Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00772369
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2008-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], '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': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D003015', 'term': 'Clostridium 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety data were solicited through a retrospective survey within 6 months of the post-4th dose of Pentacel™ vaccine.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Group', 'description': 'Received 4th dose of the Pentacel® series before 2nd birthday', 'otherNumAtRisk': 3123, 'otherNumAffected': 0, 'seriousNumAtRisk': 3213, 'seriousNumAffected': 93}], 'seriousEvents': [{'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Injury, poisoning and procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3213, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Received 4th dose of the Pentacel® series before 2nd birthday'}], 'classes': [{'title': 'Participants with no events reported', 'categories': [{'measurements': [{'value': '3023', 'groupId': 'OG000'}]}]}, {'title': 'Participants with events reported and confirmed', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}, {'title': 'Events at 0 to 180 days after Dose 4', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}, {'title': 'Events after Day 180 only', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Events prior to Dose 4 only', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Participants with events not confirmed', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post 4th dose vaccination', 'description': "Positive response is a 'Yes' to any of the following questions:\n\n1. Has your child been admitted to a hospital?\n2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office?\n3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?\n4. Has your child been diagnosed by a physician as having:\n\nLow blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?", 'unitOfMeasure': 'Particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Received 4th dose of the Pentacel® series before 2nd birthday'}], 'classes': [{'title': 'SAEs Occurring Post-dose 4 (Any)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'SAEs Occurring Post-dose 4 (Related)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Red cell aplasia (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Red cell aplasia (Related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting nos (Any)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting nos (Related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty in walking (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty in walking (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pyrexia (Any)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pyrexia (Related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypersensitivity nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypersensitivity nos (Related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bronchiolitis (Any)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Bronchiolitis (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bronchitis viral (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bronchitis viral (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bronchopneumonia nos (Any)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Bronchopneumonia nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cellulitis (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cellulitis (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Croup infectious (Any)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Croup infectious (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis nos (Any)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis rotavirus (Any)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis rotavirus (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis viral nos (Any)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis viral nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Herpes zoster (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Herpes zoster (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Kawasaki's disease (Any)", 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': "Kawasaki's disease (Related)", 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lobar pneumonia nos (Any)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Lobar pneumonia nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Localised infection (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Localised infection (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Periorbital cellulitis (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Periorbital cellulitis (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pharyngitis (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pharyngitis (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia nos (Any)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia viral nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia viral nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Tonsillitis viral nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Tonsillitis viral nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Upper respiratory tract infection nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Upper respiratory tract infection nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urinary tract infection nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urinary tract infection nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Viral infection nos (Any)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Viral infection nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Femur fracture (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Femur fracture (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hip dislocation (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hip dislocation (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes mellitus nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes mellitus nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Acute lymphocytic leukaemia (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Acute lymphocytic leukaemia (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Autism (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Autism (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Convulsions nos (Any)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Convulsions nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Febrile convulsion (Any)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Febrile convulsion (Related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Breath holding (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Breath holding (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Balanitis nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Balanitis nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Asthma nos (Any)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Asthma nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bronchitis nos (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bronchitis nos (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia aspiration (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia aspiration (Related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Wheezing (Any)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Wheezing (Related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months post 4th dose vaccination', 'description': 'SAE: any untoward medical occurrence with the following outcomes:\n\n* death,\n* a life-threatening adverse drug experience (as confirmed by the investigators),\n* inpatient hospitalization or prolongation of existing hospitalization,\n* a persistent or significant disability/incapacity, or\n* a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Response to questionnaire that were confirmed by the primary care physician's office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group', 'description': 'Received 4th dose of the Pentacel® series before 2nd birthday'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3213'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Did not return record release form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Telephone contact for this study was from 20 September 2003 to 30 April 2004.', 'preAssignmentDetails': 'A total of 3214 participants that met the inclusion and exclusion criteria were enrolled in this survey. One participant did not return a record release form and twenty-nine (29) others were also excluded from the Primary Analysis Population because their safety data could not be confirmed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3214', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group', 'description': 'Received 4th dose of the Pentacel® series before 2nd birthday'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3214', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '1.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1538', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1676', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3214', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2008-10-13', 'resultsFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2008-10-13', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-15', 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series', 'timeFrame': '6 months post 4th dose vaccination', 'description': "Positive response is a 'Yes' to any of the following questions:\n\n1. Has your child been admitted to a hospital?\n2. Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician's office?\n3. Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?\n4. Has your child been diagnosed by a physician as having:\n\nLow blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?"}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.', 'timeFrame': '6 Months post 4th dose vaccination', 'description': 'SAE: any untoward medical occurrence with the following outcomes:\n\n* death,\n* a life-threatening adverse drug experience (as confirmed by the investigators),\n* inpatient hospitalization or prolongation of existing hospitalization,\n* a persistent or significant disability/incapacity, or\n* a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pertussis', 'Whooping cough', 'Diphtheria', 'Tetanus', 'Haemophilus influenzae', 'Poliovirus Types 1, 2, and 3.'], 'conditions': ['Diphtheria', 'Pertussis', 'Haemophilus Infection', 'Tetanus', 'Polio']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this survey is to collect selected safety data.\n\nPrimary Objective:\n\nTo collect selected safety data at 6 months following the 4th dose of the Pentacel® series.', 'detailedDescription': 'This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.\n* Written Informed Consent and Telephone consent from the parent(s) or guardian(s).\n* Able to comply with the survey procedures.\n\nExclusion Criteria:\n\n* Fourth dose of the Pentacel® series received on or after the child's 2nd birthday."}, 'identificationModule': {'nctId': 'NCT00772369', 'briefTitle': 'Retrospective Survey of Safety of Fourth Dose Pentacel® in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children', 'orgStudyIdInfo': {'id': 'M5A08'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4R4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}