Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-03-26 @ 6:06 PM
Study NCT ID:
NCT04258995
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The time period for actively eliciting and collecting AEs and SAEs for each participant began from the time the participant provided informed consent, through and including Visit 2 (1 month after booster dose) for AEs and through and including Visit 3 for MAEs and SAEs (6 months after booster dose).', 'description': 'Safety population are participants who received 1 dose of the investigational product and had at least 1 safety assessment after receiving the booster dose. Medical Dictionary for Regulatory Activities (MedDRA) v23.1 was followed for AE reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'GBS6 20 μg With AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 59, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GBS6 20 μg Without AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 54, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'seriousEvents': [{'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBS6 20 μg With AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}, {'id': 'OG001', 'title': 'GBS6 20 μg Without AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}], 'classes': [{'title': 'Pain at injection site: Any', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '78.6'}, {'value': '42.7', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '54.6'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '65.5'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '27.6', 'upperLimit': '50.6'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '21.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '11.2'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Pain at injection site: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.1'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.1'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Redness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '11.2'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '11.2'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Swelling: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after booster dose', 'description': 'Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever \\>24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter \\[cm\\]), moderate (greater than \\[\\>\\] 5.0-10.0 cm),severe (\\>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis).Maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants reporting "yes" or "no" for at least 1 day were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBS6 20 μg With AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}, {'id': 'OG001', 'title': 'GBS6 20 μg Without AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}], 'classes': [{'title': 'Fever:>=38.0 degree C', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.1'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.2'}]}]}, {'title': 'Fever: 38.0°C to 38.4°C', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Fever: >38.4°C to 38.9°C', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.2'}]}]}, {'title': 'Fever: >38.9°C to 40.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Fever: >40.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Nausea/vomiting: Any', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '16.4'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '19.9'}]}]}, {'title': 'Nausea/vomiting: Mild', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '14.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '13.1'}]}]}, {'title': 'Nausea/vomiting: Moderate', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '13.1'}]}]}, {'title': 'Nausea/vomiting: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Nausea/vomiting: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Diarrhea: Any', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '26.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '26.3'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '24.4'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '19.9'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '13.1'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Diarrhea: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '41.9'}, {'value': '41.3', 'groupId': 'OG001', 'lowerLimit': '30.1', 'upperLimit': '53.3'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '31.9'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': '38.1'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '18.1'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '23.2'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.2'}]}]}, {'title': 'Headache: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Fatigue/tiredness: Any', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '56.6'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '42.4'}]}]}, {'title': 'Fatigue/tiredness: Mild', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '34.8'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '30.8'}]}]}, {'title': 'Fatigue/tiredness: Moderate', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '30.5'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '18.3'}]}]}, {'title': 'Fatigue/tiredness: Severe', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.2'}]}]}, {'title': 'Fatigue/tiredness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '34.8'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '27.8'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '21.3'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '24.7'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '18.1'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Muscle pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '21.3'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '18.3'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '14.7'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '14.9'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.1'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}, {'title': 'Joint pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after booster dose', 'description': 'Nausea/Vomiting:Mild:No interference with activity or 1-2 times in 24 hours;Moderate:Some interference with activity or\\>2 times in 24 hours;Severe:Prevented daily activity, required IV hydration.Diarrhea:Mild:2-3 loose stools in 24 hours;Moderate: 4-5 loose stools in 24 hours;Severe:\\>=6 loose stools in 24 hours.Headache:Mild:No interference with activity;Moderate:Repeated use of nonnarcotic pain reliever \\>24 hours or some interference with activity;Severe:Significant; any use of narcotic pain reliever or prevents daily activity.Fatigue:Mild:No interference with activity;Moderate: Some interference with activity;Severe: Significant; prevented daily activity.Muscle pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant;prevented daily activity.Muscle/joint pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant; prevented daily activity.Grade 4 for all AEs:Emergency visit or hospitalization.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All the participants reporting "yes" or "no" for at least 1 day were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GBS6 20 μg With AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}, {'id': 'OG001', 'title': 'GBS6 20 μg Without AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '14.7'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '21.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after booster dose', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. 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Booster Dose Month 1 - Booster Dose = Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.624', 'groupId': 'OG000', 'lowerLimit': '16.732', 'upperLimit': '33.353'}, {'value': '19.156', 'groupId': 'OG001', 'lowerLimit': '13.365', 'upperLimit': '27.456'}]}]}, {'title': 'II: Month 1 - Booster Dose Month 1 - Booster Dose = Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '189.611', 'groupId': 'OG000', 'lowerLimit': '105.577', 'upperLimit': '340.534'}, {'value': '52.439', 'groupId': 'OG001', 'lowerLimit': '18.337', 'upperLimit': '149.961'}]}]}, {'title': 'II: Month 1 - Booster Dose Month 1 - Booster Dose = Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.285', 'groupId': 'OG000', 'lowerLimit': '34.250', 'upperLimit': '59.876'}, {'value': '66.513', 'groupId': 'OG001', 'lowerLimit': '47.596', 'upperLimit': '92.948'}]}]}, {'title': 'III: Month 1 - Booster Dose Month 1 - Booster Dose = Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.612', 'groupId': 'OG000', 'lowerLimit': '4.268', 'upperLimit': '119.786'}, {'value': '18.368', 'groupId': 'OG001', 'lowerLimit': '6.559', 'upperLimit': '51.438'}]}]}, {'title': 'III: Month 1 - Booster Dose Month 1 - Booster Dose = Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.228', 'groupId': 'OG000', 'lowerLimit': '9.915', 'upperLimit': '17.647'}, {'value': '17.214', 'groupId': 'OG001', 'lowerLimit': '12.681', 'upperLimit': '23.366'}]}]}, {'title': 'IV: Month 1 - Booster Dose Month 1 - Booster Dose = Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.545', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '347896565796'}, {'value': '77.627', 'groupId': 'OG001', 'lowerLimit': '22.933', 'upperLimit': '262.759'}]}]}, {'title': 'IV: Month 1 - Booster Dose Month 1 - Booster Dose = Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.661', 'groupId': 'OG000', 'lowerLimit': '23.021', 'upperLimit': '38.216'}, {'value': '32.046', 'groupId': 'OG001', 'lowerLimit': '23.360', 'upperLimit': '43.960'}]}]}, {'title': 'V: Month 1 - Booster Dose Month 1 - Booster Dose = Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.017', 'groupId': 'OG000', 'lowerLimit': '19.528', 'upperLimit': '472.109'}, {'value': '103.130', 'groupId': 'OG001'}]}]}, {'title': 'V: Month 1 - Booster Dose Month 1 - Booster Dose = Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.465', 'groupId': 'OG000', 'lowerLimit': '25.698', 'upperLimit': '54.622'}, {'value': '51.842', 'groupId': 'OG001', 'lowerLimit': '36.385', 'upperLimit': '73.865'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after booster dose', 'description': 'Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. The pre-vaccination immunogenicity blood draw and booster vaccination were both performed on Day 1.', 'unitOfMeasure': 'microgram per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GBS6 20 μg With AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}, {'id': 'FG001', 'title': 'GBS6 20 μg Without AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Overall, a total of 151 participants were assigned and vaccinated with a single booster dose of group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) (20 microgram \\[μg\\] capsular polysaccharide \\[CPS\\]/serotype/dose) formulated with or without aluminum phosphate (AlPO4) based on the formulation received in the primary C1091001 study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GBS6 20 μg With AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) with AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated with AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}, {'id': 'BG001', 'title': 'GBS6 20 μg Without AlPO4', 'description': 'Participants who received a primary dose of GBS6 (5 μg, 10 µg, or 20 µg) without AlPO4 in Study C1091001 received a single booster dose of GBS6 (20 µg) formulated without AlPO4 intramuscularly on Day 1 and were followed up to 6 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '8.40', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '8.96', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '8.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the booster dose.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-07', 'size': 23368903, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-18T12:56', 'hasProtocol': True}, {'date': '2020-08-07', 'size': 3697791, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-18T12:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two arms in the study however based on the prior formulation received participants can only be enrolled into one predetermined arm in the study. Participants are assigned by an interactive response technology (IRT) based on prior formulation received.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2020-02-04', 'resultsFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-11', 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Prompted Local Reactions Within 14 Days Following Booster Dose (Redness, Swelling, and Pain at the Injection Site)', 'timeFrame': 'Within 14 days after booster dose', 'description': 'Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever \\>24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter \\[cm\\]), moderate (greater than \\[\\>\\] 5.0-10.0 cm),severe (\\>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis).Maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.'}, {'measure': 'Percentage of Participants Reporting Prompted Systemic Events Within 14 Days Following Booster Dose (Fever, Nausea/Vomiting, Diarrhea, Headache, Fatigue, Muscle Pain, and Joint Pain)', 'timeFrame': 'Within 14 days after booster dose', 'description': 'Nausea/Vomiting:Mild:No interference with activity or 1-2 times in 24 hours;Moderate:Some interference with activity or\\>2 times in 24 hours;Severe:Prevented daily activity, required IV hydration.Diarrhea:Mild:2-3 loose stools in 24 hours;Moderate: 4-5 loose stools in 24 hours;Severe:\\>=6 loose stools in 24 hours.Headache:Mild:No interference with activity;Moderate:Repeated use of nonnarcotic pain reliever \\>24 hours or some interference with activity;Severe:Significant; any use of narcotic pain reliever or prevents daily activity.Fatigue:Mild:No interference with activity;Moderate: Some interference with activity;Severe: Significant; prevented daily activity.Muscle pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant;prevented daily activity.Muscle/joint pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant; prevented daily activity.Grade 4 for all AEs:Emergency visit or hospitalization.'}, {'measure': 'Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month Following Booster Dose', 'timeFrame': 'Within 1 month after booster dose', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.'}, {'measure': 'Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Within 6 Months Following Booster Dose', 'timeFrame': 'Within 6 months after booster dose', 'description': 'An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Booster Dose', 'timeFrame': 'Within 6 months after booster dose', 'description': 'An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.'}], 'secondaryOutcomes': [{'measure': 'GBS Serotype-Specific IgG Geometric Mean Concentrations (GMC) Measured Before and 1 Month After Booster Dose', 'timeFrame': 'Before and 1 month after booster dose', 'description': 'Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.'}, {'measure': 'GBS Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers Measured Before to 1 Month After Booster Dose', 'timeFrame': 'Within 6 months after primary dose and within 1 month after booster dose', 'description': 'OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.'}, {'measure': 'GBS Serotype-Specific IgG Geometric Mean Fold Rise (GMFR) From Before To 1 Month After Booster Dose', 'timeFrame': '1 month after booster dose', 'description': 'IgG for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.'}, {'measure': 'GBS Serotype-Specific OPA GMFR Measured Before and 1 Month After Booster Dose', 'timeFrame': '1 month after booster dose', 'description': 'OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.'}, {'measure': 'GBS Serotype-Specific IgG GMC Measured 1 Month After Booster Dose Stratified by Baseline Pre-vaccination Status (Before the Primary Dose)', 'timeFrame': '1 month after booster dose', 'description': 'Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. The pre-vaccination immunogenicity blood draw and booster vaccination were both performed on Day 1.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Group B Streptococcal Infections']}, 'referencesModule': {'references': [{'pmid': '40523378', 'type': 'DERIVED', 'citation': 'Jongihlati B, Segall N, Block SL, Absalon J, Perez J, Munson S, Sanchez-Pearson Y, Simon R, Silmon de Monerri NC, Radley D, McLaughlin LC, Gaylord M, Gruber WC, Jansen KU, Scott DA, Anderson AS. Safety and immunogenicity of a booster dose of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 2, open-label extension of a phase 1/2 randomised controlled trial. Lancet Infect Dis. 2025 Oct;25(10):1138-1148. doi: 10.1016/S1473-3099(25)00216-6. Epub 2025 Jun 13.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C1091007', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adults (male and female) at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.\n2. Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.\n\nExclusion Criteria:\n\n1. Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 3 months after the last dose of investigational product.\n2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.\n3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.\n4. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).\n5. Previous vaccination with any licensed or investigational group B streptococcus vaccine (other than GBS6), or planned receipt during the participant's participation in the study (through 6-month telephone call)."}, 'identificationModule': {'nctId': 'NCT04258995', 'briefTitle': 'A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS', 'orgStudyIdInfo': {'id': 'C1091007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GBS6 no aluminum phosphate (GBS6 no AlPO4)', 'interventionNames': ['Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)']}, {'type': 'EXPERIMENTAL', 'label': 'GBS6 with aluminum phosphate (GBS6 with AlPO4)', 'interventionNames': ['Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)']}], 'interventions': [{'name': 'Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)', 'type': 'BIOLOGICAL', 'otherNames': ['GBS6'], 'description': '2 formulations at 1 dose level', 'armGroupLabels': ['GBS6 no aluminum phosphate (GBS6 no AlPO4)', 'GBS6 with aluminum phosphate (GBS6 with AlPO4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatric & Adult Research Inc.', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc./ Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}