Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 10:47 PM
Study NCT ID:
NCT00627458
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541235', 'term': 'diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).', 'eventGroups': [{'id': 'EG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 116, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 126, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 129, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 58}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Fever/(Rectal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 78}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 136, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 138, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia adenoviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster administration (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-HBs ≥ 10 mIU/mL', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Anti HBs ≥ 100 mIU/mL', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-HBs ≥ 10 mIU/mL', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Anti HBs ≥ 100 mIU/mL', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PRP ≥ 0.15μg/mL', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP ≥ 1.0μg/mL', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PRP ≥ 0.15 µg/mL', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRP ≥ 1.0 µg/mL', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With a Vaccine Response to PT, FHA and PR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \\[i.e. with concentrations lower than (\\<) the cut-off value\\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \\[i.e. with concentrations greater than (\\>) the cut-off value).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '0.064', 'groupId': 'OG000', 'lowerLimit': '0.058', 'upperLimit': '0.071'}, {'value': '0.069', 'groupId': 'OG001', 'lowerLimit': '0.062', 'upperLimit': '0.076'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '0.216', 'groupId': 'OG000', 'lowerLimit': '0.184', 'upperLimit': '0.254'}, {'value': '0.248', 'groupId': 'OG001', 'lowerLimit': '0.213', 'upperLimit': '0.289'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '2.237', 'groupId': 'OG000', 'lowerLimit': '1.877', 'upperLimit': '2.666'}, {'value': '2.242', 'groupId': 'OG001', 'lowerLimit': '1.868', 'upperLimit': '2.689'}]}]}, {'title': 'Anti-T', 'categories': [{'measurements': [{'value': '9.799', 'groupId': 'OG000', 'lowerLimit': '8.39', 'upperLimit': '11.444'}, {'value': '9.136', 'groupId': 'OG001', 'lowerLimit': '7.838', 'upperLimit': '10.648'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '9.1'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '8.1'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '25.9'}, {'value': '22.1', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '26.2'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '10.3'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '10.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '150.9', 'groupId': 'OG000', 'lowerLimit': '132.9', 'upperLimit': '171.2'}, {'value': '117.1', 'groupId': 'OG001', 'lowerLimit': '101.5', 'upperLimit': '135'}]}]}, {'title': 'Anti-FHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '609.6', 'groupId': 'OG000', 'lowerLimit': '534.1', 'upperLimit': '695.7'}, {'value': '533.7', 'groupId': 'OG001', 'lowerLimit': '463', 'upperLimit': '615.1'}]}]}, {'title': 'Anti-PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '308.5', 'groupId': 'OG000', 'lowerLimit': '261.3', 'upperLimit': '364.2'}, {'value': '311.7', 'groupId': 'OG001', 'lowerLimit': '260.3', 'upperLimit': '373.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '108.2'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '109.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '3291.7', 'groupId': 'OG000', 'lowerLimit': '2373.6', 'upperLimit': '4565'}, {'value': '3528.1', 'groupId': 'OG001', 'lowerLimit': '2546.1', 'upperLimit': '4888.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '16.3'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '18.9'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '11.3'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '10.5'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '11.6'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '20.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-polio 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '726.3', 'groupId': 'OG000', 'lowerLimit': '560.4', 'upperLimit': '941.4'}, {'value': '942.4', 'groupId': 'OG001', 'lowerLimit': '734.1', 'upperLimit': '1209.7'}]}]}, {'title': 'Anti-polio 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '712.8', 'groupId': 'OG000', 'lowerLimit': '529.1', 'upperLimit': '960.4'}, {'value': '812.9', 'groupId': 'OG001', 'lowerLimit': '632.8', 'upperLimit': '1044.3'}]}]}, {'title': 'Anti-polio 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '780', 'groupId': 'OG000', 'lowerLimit': '591', 'upperLimit': '1029.3'}, {'value': '1145.8', 'groupId': 'OG001', 'lowerLimit': '891.6', 'upperLimit': '1472.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.249', 'groupId': 'OG000', 'lowerLimit': '0.199', 'upperLimit': '0.31'}, {'value': '0.314', 'groupId': 'OG001', 'lowerLimit': '0.252', 'upperLimit': '0.392'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.866', 'groupId': 'OG000', 'lowerLimit': '28.61', 'upperLimit': '47.504'}, {'value': '35.318', 'groupId': 'OG001', 'lowerLimit': '27.447', 'upperLimit': '45.445'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-D, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Anti-T, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Anti-T, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-HBs ≥ 10 mIU/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Anti-HBs ≥ 10 mIU/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Anti HBs ≥ 100 mIU/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Anti HBs ≥ 100 mIU/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-polio 1, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Anti-polio 1, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'Anti-polio 2, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Anti-polio 2, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'Anti-polio 3, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Anti-polio 3, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against PT, FHA and PRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PT, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Anti-FHA, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Anti-FHA, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRN, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRN, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PRP ≥ 0.15 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRP ≥ 0.15 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRP ≥ 1.0 μg/mL, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRP ≥ 1.0 μg/mL, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Anti-D and Anti-T Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-D, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.084', 'groupId': 'OG000', 'lowerLimit': '0.073', 'upperLimit': '0.097'}]}]}, {'title': 'Anti-D, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.952', 'groupId': 'OG000', 'lowerLimit': '3.365', 'upperLimit': '4.642'}]}]}, {'title': 'Anti-T, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.261', 'groupId': 'OG000', 'lowerLimit': '0.219', 'upperLimit': '0.31'}]}]}, {'title': 'Anti-T, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.833', 'groupId': 'OG000', 'lowerLimit': '9.505', 'upperLimit': '12.347'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '10.3'}]}]}, {'title': 'Anti-PT, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '153.7', 'groupId': 'OG000', 'lowerLimit': '135.1', 'upperLimit': '174.9'}]}]}, {'title': 'Anti-FHA, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '41.1'}]}]}, {'title': 'Anti-FHA, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '791.9', 'groupId': 'OG000', 'lowerLimit': '708.8', 'upperLimit': '884.8'}]}]}, {'title': 'Anti-PRN, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '18.5'}]}]}, {'title': 'Anti-PRN, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '564.1', 'groupId': 'OG000', 'lowerLimit': '489.5', 'upperLimit': '650.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-HBs, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.8', 'groupId': 'OG000', 'lowerLimit': '107.2', 'upperLimit': '182.3'}]}]}, {'title': 'Anti-HBs, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6132.7', 'groupId': 'OG000', 'lowerLimit': '4587.8', 'upperLimit': '8197.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Anti-poliovirus Type 1, 2 and 3 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-polio 1, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '27.4'}]}]}, {'title': 'Anti-polio 1, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1288.8', 'groupId': 'OG000', 'lowerLimit': '1029.1', 'upperLimit': '1614'}]}]}, {'title': 'Anti-polio 2, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '15'}]}]}, {'title': 'Anti-polio 2, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1231', 'groupId': 'OG000', 'lowerLimit': '961', 'upperLimit': '1576.9'}]}]}, {'title': 'Anti-polio 3, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '27.7'}]}]}, {'title': 'Anti-polio 3, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1794.8', 'groupId': 'OG000', 'lowerLimit': '1426.8', 'upperLimit': '2257.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PRP, M0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.487', 'groupId': 'OG000', 'lowerLimit': '0.383', 'upperLimit': '0.62'}]}]}, {'title': 'Anti-PRP, M1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.087', 'groupId': 'OG000', 'lowerLimit': '60.224', 'upperLimit': '98.672'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Vaccine Response to PT, FHA and PR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Anti-PT, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PT, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PT, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'Anti-FHA, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anti-FHA, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Anti-FHA, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRN, S-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRN, S+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Anti-PRN, Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month after the booster dose (At Month 1)', 'description': 'Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations \\< cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations \\> cut-off value).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after the booster vaccination', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever (Rectal)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}, {'title': 'Any Loss of Appetite', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after the booster vaccination', 'description': 'Assessed solicited general symptoms were drowsiness, fever \\[defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 31-day (Day 0-30) follow-up period after the booster vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 to Month 1, during the entire study period', 'description': 'Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'classes': [{'title': 'Any concomitant medication', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}]}, {'title': 'Any antipyretic', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after the booster vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'FG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Migrated from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '403', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Infanrix Hexa PF Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'BG001', 'title': 'Infanrix Hexa PC Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '1.12', 'groupId': 'BG000'}, {'value': '18', 'spread': '1.03', 'groupId': 'BG001'}, {'value': '17.8', 'spread': '1.11', 'groupId': 'BG002'}, {'value': '17.90', 'spread': '1.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'categories': [{'title': 'White-Caucasian/European heritage', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '394', 'groupId': 'BG003'}]}, {'title': 'White-Arabic/North African heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not specified', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2009-05-20', 'completionDateStruct': {'date': '2008-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2008-02-20', 'dispFirstSubmitQcDate': '2009-05-21', 'resultsFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2008-02-20', 'dispFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-07', 'studyFirstPostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'timeFrame': 'Before the booster administration (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.'}, {'measure': 'Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.'}, {'measure': 'Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).'}, {'measure': 'Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.'}, {'measure': 'Number of Subjects With a Vaccine Response to PT, FHA and PR', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \\[i.e. with concentrations lower than (\\<) the cut-off value\\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \\[i.e. with concentrations greater than (\\>) the cut-off value).'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': 'Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.'}, {'measure': 'Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'Before the booster vaccination (At Month 0)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'One month after the booster vaccination (At Month 1)', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .'}, {'measure': 'Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.'}, {'measure': 'Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.'}, {'measure': 'Number of Seroprotected Subjects Against PT, FHA and PRN', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .'}, {'measure': 'Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.'}, {'measure': 'Anti-D and Anti-T Antibody Concentrations', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.'}, {'measure': 'Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': 'Anti-HBs Antibody Concentrations', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.'}, {'measure': 'Anti-poliovirus Type 1, 2 and 3 Antibody Titers', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody titers were presented as geometric mean titers (GMTs).'}, {'measure': 'Anti-PRP Antibody Concentrations', 'timeFrame': 'Before (Month 0) and one month after (Month 1) the booster vaccination', 'description': 'Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.'}, {'measure': 'Number of Subjects With a Vaccine Response to PT, FHA and PR', 'timeFrame': 'One month after the booster dose (At Month 1)', 'description': 'Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations \\< cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations \\> cut-off value).'}, {'measure': 'Number of Subjects With Any Solicited Local Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after the booster vaccination', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects With Any Solicited General Symptoms', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after the booster vaccination', 'description': 'Assessed solicited general symptoms were drowsiness, fever \\[defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 31-day (Day 0-30) follow-up period after the booster vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Month 0 to Month 1, during the entire study period', 'description': 'Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects Reporting Concomitant Medications', 'timeFrame': 'During the 4-day (Days 0-3) follow-up period after the booster vaccination'}]}, 'conditionsModule': {'keywords': ['Hexavalent vaccine', 'Booster'], 'conditions': ['Acellular Pertussis', 'Diphtheria', 'Poliomyelitis', 'Haemophilus Influenzae Type b', 'Tetanus', 'Hepatitis B']}, 'referencesModule': {'availIpds': [{'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111344', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).', 'detailedDescription': 'This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '20 Months', 'minimumAge': '16 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol\n* Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.\n* A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.\n* Written informed consent obtained from the parent or guardian of the subject\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.\n* Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.\n* Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT00627458', 'briefTitle': "Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose", 'orgStudyIdInfo': {'id': '111344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INFANRIX HEXA PF GROUP', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.', 'interventionNames': ['Biological: Infanrix Hexa']}, {'type': 'EXPERIMENTAL', 'label': 'INFANRIX HEXA PC GROUP', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.', 'interventionNames': ['Biological: Infanrix Hexa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.', 'interventionNames': ['Biological: Infanrix Hexa']}], 'interventions': [{'name': 'Infanrix Hexa', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biological's combined DTPa-HBV-IPV/Hib vaccine"], 'description': 'Vaccine administered as a booster dose at 16-20 months of age', 'armGroupLabels': ['CONTROL GROUP', 'INFANRIX HEXA PC GROUP', 'INFANRIX HEXA PF GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '01300', 'city': 'Vantaa', 'country': 'Finland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}