Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05266456
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2022-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialsgov@vaxcyte.com', 'phone': '(650) 585-0029', 'title': 'Vice President of Clinical Development', 'organization': 'Vaxcyte'}, 'certainAgreement': {'otherDetails': 'Sponsor shall review within the ninety (90) day period. Upon receiving any notification from Sponsor requesting deletion of Confidential Information, correction of inaccuracies, or a delay in publication to allow the filing of patent application, Institution or Investigator shall take the requested action of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Some limitations of this clinical study include the lack of a group, such as 3·3 µg or 4·4 µg, for all serotypes, aimed at understanding whether the dose response of polysaccharide can overcome carrier suppression. The relatively low ethnic diversity of participants is also a limitation, which will be addressed in larger phase 3 clinical trials.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.', 'eventGroups': [{'id': 'EG000', 'title': 'VAX-24 Low Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VAX-24 Mid Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'VAX-24 Mixed Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PCV20 18-49 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'VAX-24 Low Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 161, 'seriousNumAtRisk': 193, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'VAX-24 Mid Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 155, 'seriousNumAtRisk': 191, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'VAX-24 Mixed Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 164, 'seriousNumAtRisk': 191, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'PCV20 50-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 196, 'deathsNumAtRisk': 196, 'otherNumAffected': 163, 'seriousNumAtRisk': 196, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'VAX-24 Low Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 170, 'seriousNumAtRisk': 209, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'VAX-24 Mid Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 168, 'seriousNumAtRisk': 207, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'VAX-24 Mixed Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 178, 'seriousNumAtRisk': 207, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'PCV20 18-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 179, 'seriousNumAtRisk': 212, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 137}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 136}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 147}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 137}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 146}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 148}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 160}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 150}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 17}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 16}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 20}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 21}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 20}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 17}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 19}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 82}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 78}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 78}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 78}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 88}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 83}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 84}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 59}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 55}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 58}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 59}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 64}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 61}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 62}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 110}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 107}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 115}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 104}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 116}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 113}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 118}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 113}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 48}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 31}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 53}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 47}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 52}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 33}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 55}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bladder Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Forearm Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 212, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '193', 'groupId': 'OG004'}, {'value': '191', 'groupId': 'OG005'}, {'value': '191', 'groupId': 'OG006'}, {'value': '196', 'groupId': 'OG007'}, {'value': '209', 'groupId': 'OG008'}, {'value': '207', 'groupId': 'OG009'}, {'value': '207', 'groupId': 'OG010'}, {'value': '212', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20 18-49 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG004', 'title': 'VAX-24 Low Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG005', 'title': 'VAX-24 Mid Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG006', 'title': 'VAX-24 Mixed Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG007', 'title': 'PCV20 50-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG008', 'title': 'VAX24 Low Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG009', 'title': 'VAX-24 Mid Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG010', 'title': 'VAX-24 Mixed Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG011', 'title': 'PCV20 18-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'title': 'Any solicited local AE; Overall, Any Grade', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}, {'value': '81.3', 'groupId': 'OG002'}, {'value': '93.8', 'groupId': 'OG003'}, {'value': '73.6', 'groupId': 'OG004'}, {'value': '71.7', 'groupId': 'OG005'}, {'value': '77.5', 'groupId': 'OG006'}, {'value': '71.9', 'groupId': 'OG007'}, {'value': '72.2', 'groupId': 'OG008'}, {'value': '72.5', 'groupId': 'OG009'}, {'value': '77.8', 'groupId': 'OG010'}, {'value': '73.6', 'groupId': 'OG011'}]}]}, {'title': 'Pain at injection site; Overall, Any Grade', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '81.3', 'groupId': 'OG002'}, {'value': '81.3', 'groupId': 'OG003'}, {'value': '71.0', 'groupId': 'OG004'}, {'value': '71.2', 'groupId': 'OG005'}, {'value': '77.0', 'groupId': 'OG006'}, {'value': '69.9', 'groupId': 'OG007'}, {'value': '69.9', 'groupId': 'OG008'}, {'value': '71.5', 'groupId': 'OG009'}, {'value': '77.3', 'groupId': 'OG010'}, {'value': '70.8', 'groupId': 'OG011'}]}]}, {'title': 'Erythema (redness) at injection site; Overall, Any Grade', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '6.7', 'groupId': 'OG004'}, {'value': '7.9', 'groupId': 'OG005'}, {'value': '8.9', 'groupId': 'OG006'}, {'value': '8.7', 'groupId': 'OG007'}, {'value': '6.7', 'groupId': 'OG008'}, {'value': '7.7', 'groupId': 'OG009'}, {'value': '9.7', 'groupId': 'OG010'}, {'value': '9.9', 'groupId': 'OG011'}]}]}, {'title': 'Edema (swelling) at injection site; Overall, Any Grade', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '18.8', 'groupId': 'OG003'}, {'value': '8.8', 'groupId': 'OG004'}, {'value': '7.9', 'groupId': 'OG005'}, {'value': '7.9', 'groupId': 'OG006'}, {'value': '10.7', 'groupId': 'OG007'}, {'value': '9.6', 'groupId': 'OG008'}, {'value': '8.2', 'groupId': 'OG009'}, {'value': '9.2', 'groupId': 'OG010'}, {'value': '11.3', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after vaccination', 'description': 'Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all patients exposed to study vaccine. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '193', 'groupId': 'OG004'}, {'value': '191', 'groupId': 'OG005'}, {'value': '191', 'groupId': 'OG006'}, {'value': '196', 'groupId': 'OG007'}, {'value': '209', 'groupId': 'OG008'}, {'value': '207', 'groupId': 'OG009'}, {'value': '207', 'groupId': 'OG010'}, {'value': '212', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20 18-49 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG004', 'title': 'VAX-24 Low Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG005', 'title': 'VAX-24 Mid Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG006', 'title': 'VAX-24 Mixed Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG007', 'title': 'PCV20 50-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG008', 'title': 'VAX-24 Low Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG009', 'title': 'VAX-24 Mid Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG010', 'title': 'VAX-24 Mixed Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG011', 'title': 'PCV20 18-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'title': 'Any solicited systemic adverse event', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}, {'value': '56.3', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '69.4', 'groupId': 'OG004'}, {'value': '69.6', 'groupId': 'OG005'}, {'value': '71.2', 'groupId': 'OG006'}, {'value': '64.8', 'groupId': 'OG007'}, {'value': '67.9', 'groupId': 'OG008'}, {'value': '69.1', 'groupId': 'OG009'}, {'value': '70.0', 'groupId': 'OG010'}, {'value': '65.6', 'groupId': 'OG011'}]}]}, {'title': 'Fever (oral temperature >= 100.4ºF)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '12.5', 'groupId': 'OG003'}, {'value': '1.0', 'groupId': 'OG004'}, {'value': '0.5', 'groupId': 'OG005'}, {'value': '2.1', 'groupId': 'OG006'}, {'value': '1.0', 'groupId': 'OG007'}, {'value': '1.4', 'groupId': 'OG008'}, {'value': '1.0', 'groupId': 'OG009'}, {'value': '1.9', 'groupId': 'OG010'}, {'value': '1.9', 'groupId': 'OG011'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}, {'value': '37.5', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '42.5', 'groupId': 'OG004'}, {'value': '40.8', 'groupId': 'OG005'}, {'value': '40.8', 'groupId': 'OG006'}, {'value': '39.8', 'groupId': 'OG007'}, {'value': '42.1', 'groupId': 'OG008'}, {'value': '40.1', 'groupId': 'OG009'}, {'value': '40.6', 'groupId': 'OG010'}, {'value': '40.6', 'groupId': 'OG011'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '37.5', 'groupId': 'OG003'}, {'value': '30.6', 'groupId': 'OG004'}, {'value': '28.8', 'groupId': 'OG005'}, {'value': '30.4', 'groupId': 'OG006'}, {'value': '30.1', 'groupId': 'OG007'}, {'value': '30.6', 'groupId': 'OG008'}, {'value': '29.5', 'groupId': 'OG009'}, {'value': '30.0', 'groupId': 'OG010'}, {'value': '30.7', 'groupId': 'OG011'}]}]}, {'title': 'Muscle Pain', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': '56.3', 'groupId': 'OG003'}, {'value': '57.0', 'groupId': 'OG004'}, {'value': '56.0', 'groupId': 'OG005'}, {'value': '60.2', 'groupId': 'OG006'}, {'value': '53.1', 'groupId': 'OG007'}, {'value': '55.5', 'groupId': 'OG008'}, {'value': '54.6', 'groupId': 'OG009'}, {'value': '57.0', 'groupId': 'OG010'}, {'value': '53.3', 'groupId': 'OG011'}]}]}, {'title': 'Joint Pain', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '43.8', 'groupId': 'OG003'}, {'value': '24.9', 'groupId': 'OG004'}, {'value': '16.2', 'groupId': 'OG005'}, {'value': '27.7', 'groupId': 'OG006'}, {'value': '24.0', 'groupId': 'OG007'}, {'value': '24.9', 'groupId': 'OG008'}, {'value': '15.9', 'groupId': 'OG009'}, {'value': '26.6', 'groupId': 'OG010'}, {'value': '25.5', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after vaccination', 'description': 'Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, which included all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '193', 'groupId': 'OG004'}, {'value': '191', 'groupId': 'OG005'}, {'value': '191', 'groupId': 'OG006'}, {'value': '196', 'groupId': 'OG007'}, {'value': '209', 'groupId': 'OG008'}, {'value': '207', 'groupId': 'OG009'}, {'value': '207', 'groupId': 'OG010'}, {'value': '212', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20 18-49 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG004', 'title': 'VAX-24 Low Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG005', 'title': 'VAX-24 Mid Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG006', 'title': 'VAX-24 Mixed Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG007', 'title': 'PCV20 50-64', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG008', 'title': 'VAX-24 Low Dose 18-64', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG009', 'title': 'VAX-24 Mid Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG010', 'title': 'VAX-24 Mixed Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG011', 'title': 'PCV20 18-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}, {'value': '6.3', 'groupId': 'OG003'}, {'value': '15.5', 'groupId': 'OG004'}, {'value': '11.5', 'groupId': 'OG005'}, {'value': '13.1', 'groupId': 'OG006'}, {'value': '16.8', 'groupId': 'OG007'}, {'value': '15.3', 'groupId': 'OG008'}, {'value': '11.6', 'groupId': 'OG009'}, {'value': '12.6', 'groupId': 'OG010'}, {'value': '16.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after vaccination', 'description': 'Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, including all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '193', 'groupId': 'OG004'}, {'value': '191', 'groupId': 'OG005'}, {'value': '191', 'groupId': 'OG006'}, {'value': '196', 'groupId': 'OG007'}, {'value': '209', 'groupId': 'OG008'}, {'value': '207', 'groupId': 'OG009'}, {'value': '207', 'groupId': 'OG010'}, {'value': '212', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20 18-49 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG004', 'title': 'VAX-24 Low Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG005', 'title': 'VAX-24 Mid Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG006', 'title': 'VAX-24 Mixed Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG007', 'title': 'PCV20 50-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG008', 'title': 'VAX-24 Low Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG009', 'title': 'VAX-24 Mid Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG010', 'title': 'VAX-24 Mixed Dose 18-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG011', 'title': 'PCV20 18-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'title': 'Subjects with at least one SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.0', 'groupId': 'OG004'}, {'value': '1.6', 'groupId': 'OG005'}, {'value': '0.5', 'groupId': 'OG006'}, {'value': '2.0', 'groupId': 'OG007'}, {'value': '1.0', 'groupId': 'OG008'}, {'value': '1.4', 'groupId': 'OG009'}, {'value': '0.5', 'groupId': 'OG010'}, {'value': '1.9', 'groupId': 'OG011'}]}]}, {'title': 'Subjects with at least one NOCI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1.6', 'groupId': 'OG004'}, {'value': '1.6', 'groupId': 'OG005'}, {'value': '3.1', 'groupId': 'OG006'}, {'value': '2.6', 'groupId': 'OG007'}, {'value': '1.4', 'groupId': 'OG008'}, {'value': '1.4', 'groupId': 'OG009'}, {'value': '2.9', 'groupId': 'OG010'}, {'value': '2.4', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after vaccination', 'description': 'Percentage of participants with SAEs and NOCIs', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, including all subjects in the exposed population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'title': 'Bicarbonate: Low', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}, {'value': '11.8', 'groupId': 'OG003'}]}]}, {'title': 'Cholesterol: High', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '8.7', 'groupId': 'OG002'}, {'value': '8.5', 'groupId': 'OG003'}]}]}, {'title': 'Triglycerides: High', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}, {'value': '10.8', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine: High', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}, {'value': '8.5', 'groupId': 'OG003'}]}]}, {'title': 'Glucose: High', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'Uric Acid: High', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '5.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after vaccination', 'description': 'Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in \\>5% of Subjects Aged 50 to 64 Years', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified analysis population included all subjects age 50-64 in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.'}, {'type': 'SECONDARY', 'title': 'VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '190.08', 'groupId': 'OG000', 'lowerLimit': '147.05', 'upperLimit': '245.69'}, {'value': '317.62', 'groupId': 'OG001', 'lowerLimit': '246.32', 'upperLimit': '409.56'}, {'value': '228.09', 'groupId': 'OG002', 'lowerLimit': '176.35', 'upperLimit': '295.01'}, {'value': '358.18', 'groupId': 'OG003', 'lowerLimit': '278.29', 'upperLimit': '461.00'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1371.45', 'groupId': 'OG000', 'lowerLimit': '1135.70', 'upperLimit': '1656.12'}, {'value': '1698.18', 'groupId': 'OG001', 'lowerLimit': '1409.82', 'upperLimit': '2045.51'}, {'value': '1822.43', 'groupId': 'OG002', 'lowerLimit': '1509.74', 'upperLimit': '2199.89'}, {'value': '62.40', 'groupId': 'OG003', 'lowerLimit': 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'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20.'}, {'type': 'SECONDARY', 'title': 'VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VAX-24 Low Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG001', 'title': 'VAX-24 Mid Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG002', 'title': 'VAX-24 Mixed Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'OG003', 'title': 'PCV20', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '3.55'}, {'value': '4.65', 'groupId': 'OG001', 'lowerLimit': '3.75', 'upperLimit': '5.77'}, {'value': '4.01', 'groupId': 'OG002', 'lowerLimit': '3.22', 'upperLimit': '4.99'}, {'value': '4.39', 'groupId': 'OG003', 'lowerLimit': '3.54', 'upperLimit': '5.45'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.31', 'groupId': 'OG000', 'lowerLimit': '10.99', 'upperLimit': '16.11'}, {'value': '16.37', 'groupId': 'OG001', 'lowerLimit': '13.56', 'upperLimit': '19.76'}, {'value': '18.73', 'groupId': 'OG002', 'lowerLimit': '15.47', 'upperLimit': '22.68'}, {'value': '1.02', 'groupId': 'OG003', 'lowerLimit': '0.85', 'upperLimit': '1.23'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '0.50'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.64'}, {'value': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '0.97'}, {'value': '0.48', 'groupId': 'OG003', 'lowerLimit': '0.40', 'upperLimit': '0.59'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '2.21'}, {'value': '2.52', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '3.10'}, {'value': '1.83', 'groupId': 'OG002', 'lowerLimit': '1.48', 'upperLimit': '2.26'}, {'value': '2.02', 'groupId': 'OG003', 'lowerLimit': '1.64', 'upperLimit': '2.48'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000', 'lowerLimit': '1.66', 'upperLimit': '2.73'}, {'value': '2.42', 'groupId': 'OG001', 'lowerLimit': '1.90', 'upperLimit': '3.10'}, {'value': '1.78', 'groupId': 'OG002', 'lowerLimit': '1.39', 'upperLimit': '2.28'}, {'value': '3.70', 'groupId': 'OG003', 'lowerLimit': '2.90', 'upperLimit': '4.73'}]}]}, {'title': '6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.92', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '5.11'}, {'value': '4.66', 'groupId': 'OG001', 'lowerLimit': '3.59', 'upperLimit': '6.06'}, {'value': '4.38', 'groupId': 'OG002', 'lowerLimit': '3.36', 'upperLimit': '5.71'}, {'value': '4.62', 'groupId': 'OG003', 'lowerLimit': '3.56', 'upperLimit': '5.99'}]}]}, {'title': '6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '3.73'}, {'value': '3.78', 'groupId': 'OG001', 'lowerLimit': '2.87', 'upperLimit': '4.97'}, {'value': '4.43', 'groupId': 'OG002', 'lowerLimit': '3.36', 'upperLimit': '5.86'}, {'value': '2.44', 'groupId': 'OG003', 'lowerLimit': '1.85', 'upperLimit': '3.20'}]}]}, {'title': '7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '4.10', 'upperLimit': '6.04'}, {'value': '6.29', 'groupId': 'OG001', 'lowerLimit': '5.20', 'upperLimit': '7.61'}, {'value': '8.82', 'groupId': 'OG002', 'lowerLimit': '7.26', 'upperLimit': '10.70'}, {'value': '4.74', 'groupId': 'OG003', 'lowerLimit': '3.92', 'upperLimit': '5.73'}]}]}, {'title': '8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.94', 'groupId': 'OG000', 'lowerLimit': '7.25', 'upperLimit': '11.02'}, {'value': '8.79', 'groupId': 'OG001', 'lowerLimit': '7.15', 'upperLimit': '10.81'}, {'value': '8.94', 'groupId': 'OG002', 'lowerLimit': '7.25', 'upperLimit': '11.02'}, {'value': '7.30', 'groupId': 'OG003', 'lowerLimit': '5.95', 'upperLimit': '8.97'}]}]}, {'title': '9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.98', 'groupId': 'OG000', 'lowerLimit': '6.72', 'upperLimit': '9.48'}, {'value': '10.78', 'groupId': 'OG001', 'lowerLimit': '9.10', 'upperLimit': '12.78'}, {'value': '7.91', 'groupId': 'OG002', 'lowerLimit': '6.66', 'upperLimit': '9.40'}, {'value': '2.52', 'groupId': 'OG003', 'lowerLimit': '2.13', 'upperLimit': '2.99'}]}]}, {'title': '9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.93', 'groupId': 'OG000', 'lowerLimit': '3.13', 'upperLimit': '4.92'}, {'value': '5.12', 'groupId': 'OG001', 'lowerLimit': '4.10', 'upperLimit': '6.40'}, {'value': '7.15', 'groupId': 'OG002', 'lowerLimit': '5.71', 'upperLimit': '8.97'}, {'value': '2.94', 'groupId': 'OG003', 'lowerLimit': '2.36', 'upperLimit': '3.67'}]}]}, {'title': '10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.73', 'groupId': 'OG000', 'lowerLimit': '5.30', 'upperLimit': '8.54'}, {'value': '7.90', 'groupId': 'OG001', 'lowerLimit': '6.24', 'upperLimit': '10.00'}, {'value': '6.58', 'groupId': 'OG002', 'lowerLimit': '5.18', 'upperLimit': '8.36'}, {'value': '9.38', 'groupId': 'OG003', 'lowerLimit': '7.41', 'upperLimit': '11.86'}]}]}, {'title': '11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.62', 'groupId': 'OG000', 'lowerLimit': '4.73', 'upperLimit': '6.67'}, {'value': '5.76', 'groupId': 'OG001', 'lowerLimit': '4.86', 'upperLimit': '6.83'}, {'value': '4.87', 'groupId': 'OG002', 'lowerLimit': '4.10', 'upperLimit': '5.78'}, {'value': '3.72', 'groupId': 'OG003', 'lowerLimit': '3.14', 'upperLimit': '4.40'}]}]}, {'title': '12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '2.15'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '1.72', 'upperLimit': '2.64'}, {'value': '1.91', 'groupId': 'OG002', 'lowerLimit': '1.54', 'upperLimit': '2.38'}, {'value': '1.15', 'groupId': 'OG003', 'lowerLimit': '0.93', 'upperLimit': '1.42'}]}]}, {'title': '14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.62', 'groupId': 'OG000', 'lowerLimit': '6.54', 'upperLimit': '11.36'}, {'value': '10.47', 'groupId': 'OG001', 'lowerLimit': '7.97', 'upperLimit': '13.75'}, {'value': '10.47', 'groupId': 'OG002', 'lowerLimit': '7.93', 'upperLimit': '13.81'}, {'value': '8.17', 'groupId': 'OG003', 'lowerLimit': '6.23', 'upperLimit': '10.72'}]}]}, {'title': '15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.67', 'groupId': 'OG000', 'lowerLimit': '8.61', 'upperLimit': '13.23'}, {'value': '14.09', 'groupId': 'OG001', 'lowerLimit': '11.41', 'upperLimit': '17.40'}, {'value': '11.59', 'groupId': 'OG002', 'lowerLimit': '9.36', 'upperLimit': '14.36'}, {'value': '14.81', 'groupId': 'OG003', 'lowerLimit': '12.00', 'upperLimit': '18.27'}]}]}, {'title': '17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.57', 'groupId': 'OG000', 'lowerLimit': '7.92', 'upperLimit': '11.56'}, {'value': '10.51', 'groupId': 'OG001', 'lowerLimit': '8.72', 'upperLimit': '12.67'}, {'value': '9.89', 'groupId': 'OG002', 'lowerLimit': '8.18', 'upperLimit': '11.95'}, {'value': '0.46', 'groupId': 'OG003', 'lowerLimit': '0.38', 'upperLimit': '0.55'}]}]}, {'title': '18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.66', 'groupId': 'OG000', 'lowerLimit': '5.10', 'upperLimit': '8.70'}, {'value': '8.50', 'groupId': 'OG001', 'lowerLimit': '6.53', 'upperLimit': '11.07'}, {'value': '10.35', 'groupId': 'OG002', 'lowerLimit': '7.92', 'upperLimit': '13.53'}, {'value': '6.67', 'groupId': 'OG003', 'lowerLimit': '5.13', 'upperLimit': '8.67'}]}]}, {'title': '19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.35', 'groupId': 'OG000', 'lowerLimit': '5.80', 'upperLimit': '9.31'}, {'value': '9.21', 'groupId': 'OG001', 'lowerLimit': '7.29', 'upperLimit': '11.64'}, {'value': '11.50', 'groupId': 'OG002', 'lowerLimit': '9.07', 'upperLimit': '14.58'}, {'value': '8.84', 'groupId': 'OG003', 'lowerLimit': '7.01', 'upperLimit': '11.16'}]}]}, {'title': '19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.98', 'groupId': 'OG000', 'lowerLimit': '3.80', 'upperLimit': '6.52'}, {'value': '8.92', 'groupId': 'OG001', 'lowerLimit': '6.83', 'upperLimit': '11.64'}, {'value': '9.96', 'groupId': 'OG002', 'lowerLimit': '7.60', 'upperLimit': '13.04'}, {'value': '4.34', 'groupId': 'OG003', 'lowerLimit': '3.33', 'upperLimit': '5.66'}]}]}, {'title': '20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '177', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.53', 'groupId': 'OG000', 'lowerLimit': '16.82', 'upperLimit': '22.68'}, {'value': '24.90', 'groupId': 'OG001', 'lowerLimit': '21.49', 'upperLimit': '28.84'}, {'value': '19.40', 'groupId': 'OG002', 'lowerLimit': '16.71', 'upperLimit': '22.52'}, {'value': '4.06', 'groupId': 'OG003', 'lowerLimit': '3.50', 'upperLimit': '4.70'}]}]}, {'title': '22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.13', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '5.00'}, {'value': '5.45', 'groupId': 'OG001', 'lowerLimit': '4.51', 'upperLimit': '6.59'}, {'value': '3.81', 'groupId': 'OG002', 'lowerLimit': '3.15', 'upperLimit': '4.61'}, {'value': '7.32', 'groupId': 'OG003', 'lowerLimit': '6.06', 'upperLimit': '8.83'}]}]}, {'title': '23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.60', 'groupId': 'OG000', 'lowerLimit': '3.59', 'upperLimit': '5.87'}, {'value': '5.90', 'groupId': 'OG001', 'lowerLimit': '4.63', 'upperLimit': '7.52'}, {'value': '5.27', 'groupId': 'OG002', 'lowerLimit': '4.12', 'upperLimit': '6.73'}, {'value': '5.18', 'groupId': 'OG003', 'lowerLimit': '4.07', 'upperLimit': '6.59'}]}]}, {'title': '33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.20', 'groupId': 'OG000', 'lowerLimit': '10.11', 'upperLimit': '14.72'}, {'value': '17.58', 'groupId': 'OG001', 'lowerLimit': '14.60', 'upperLimit': '21.17'}, {'value': '11.82', 'groupId': 'OG002', 'lowerLimit': '9.77', 'upperLimit': '14.30'}, {'value': '9.73', 'groupId': 'OG003', 'lowerLimit': '8.08', 'upperLimit': '11.71'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after vaccination', 'description': 'Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VAX-24 Low Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at the 1.1 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'FG001', 'title': 'VAX-24 Mid Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'FG002', 'title': 'VAX-24 Mixed Dose', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'FG003', 'title': 'PCV20', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}], 'periods': [{'title': 'Phase 1, Adults 18-49 Years of Age', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Phase 2, Adults 50-64 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '192'}, {'groupId': 'FG003', 'numSubjects': '194'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '186'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unavailable for follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First subject was enrolled 22-Feb-2022 and last subject randomized/vaccinated was 01-Jul-22. Study sites were medical clinics.', 'preAssignmentDetails': 'In Phase 1, 95 participants were screened; 21 did not meet inclusion/exclusion criteria, 4 withdrew consent, and 6 discontinued for other reason. Five of Phase 1 screen failures were rescreened and enrolled in Phase 2. An additional 1001 participants were screened (for a total of 1006); of these, 235 failed screening: 173 did not meet inclusion/exclusion criteria, 12 withdrew consent, and 50 failed for other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}, {'value': '192', 'groupId': 'BG005'}, {'value': '192', 'groupId': 'BG006'}, {'value': '194', 'groupId': 'BG007'}, {'value': '835', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'VAX-24 Low Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG001', 'title': 'VAX-24 Mid Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG002', 'title': 'VAX-24 Mixed Dose 18-49 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG003', 'title': 'PCV20 18-49 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG004', 'title': 'VAX-24 Low Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG005', 'title': 'VAX-24 Mid Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG006', 'title': 'VAX-24 Mixed Dose 50-64 Yrs', 'description': 'Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.\n\n24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG007', 'title': 'PCV20 50-64 Yrs', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.\n\n20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'groupId': 'BG000', 'lowerLimit': '35.0', 'upperLimit': '46.5'}, {'value': '34.0', 'groupId': 'BG001', 'lowerLimit': '30.0', 'upperLimit': '37.5'}, {'value': '39.0', 'groupId': 'BG002', 'lowerLimit': '28.5', 'upperLimit': '43.0'}, {'value': '37.0', 'groupId': 'BG003', 'lowerLimit': '26.5', 'upperLimit': '41.5'}, {'value': '57.0', 'groupId': 'BG004', 'lowerLimit': '53.0', 'upperLimit': '60.0'}, {'value': '57.0', 'groupId': 'BG005', 'lowerLimit': '53.5', 'upperLimit': '60.0'}, {'value': '57.0', 'groupId': 'BG006', 'lowerLimit': '53.0', 'upperLimit': '60.0'}, {'value': '57.0', 'groupId': 'BG007', 'lowerLimit': '53.0', 'upperLimit': '60.0'}, {'value': '57.0', 'groupId': 'BG008', 'lowerLimit': '53.0', 'upperLimit': '60.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '121', 'groupId': 'BG005'}, {'value': '134', 'groupId': 'BG006'}, {'value': '127', 'groupId': 'BG007'}, {'value': '522', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '58', 'groupId': 'BG006'}, {'value': '67', 'groupId': 'BG007'}, {'value': '313', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '93', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}, {'value': '172', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}, {'value': '177', 'groupId': 'BG007'}, {'value': '737', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 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'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '145', 'groupId': 'BG004'}, {'value': '157', 'groupId': 'BG005'}, {'value': '156', 'groupId': 'BG006'}, {'value': '154', 'groupId': 'BG007'}, {'value': '646', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 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{'value': '170.8', 'groupId': 'BG003', 'lowerLimit': '165.1', 'upperLimit': '176.6'}, {'value': '168.3', 'groupId': 'BG004', 'lowerLimit': '162.6', 'upperLimit': '176.5'}, {'value': '167.6', 'groupId': 'BG005', 'lowerLimit': '162.6', 'upperLimit': '175.3'}, {'value': '167.6', 'groupId': 'BG006', 'lowerLimit': '160.6', 'upperLimit': '173.0'}, {'value': '167.6', 'groupId': 'BG007', 'lowerLimit': '160.0', 'upperLimit': '176.5'}, {'value': '167.6', 'groupId': 'BG008', 'lowerLimit': '161.3', 'upperLimit': '175.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '80.85', 'groupId': 'BG000', 'lowerLimit': '69.91', 'upperLimit': '96.16'}, {'value': '92.10', 'groupId': 'BG001', 'lowerLimit': '74.94', 'upperLimit': '117.24'}, {'value': '90.50', 'groupId': 'BG002', 'lowerLimit': '71.96', 'upperLimit': '103.65'}, {'value': '78.07', 'groupId': 'BG003', 'lowerLimit': '72.04', 'upperLimit': '96.62'}, {'value': '87.82', 'groupId': 'BG004', 'lowerLimit': '71.85', 'upperLimit': '103.42'}, {'value': '86.72', 'groupId': 'BG005', 'lowerLimit': '72.58', 'upperLimit': '104.33'}, {'value': '83.10', 'groupId': 'BG006', 'lowerLimit': '70.46', 'upperLimit': '97.39'}, {'value': '82.83', 'groupId': 'BG007', 'lowerLimit': '70.31', 'upperLimit': '97.52'}, {'value': '84.81', 'groupId': 'BG008', 'lowerLimit': '71.67', 'upperLimit': '99.97'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Mass Index (kg/m^2) Median, Q1 - Q3', 'classes': [{'categories': [{'measurements': [{'value': '26.99', 'groupId': 'BG000', 'lowerLimit': '24.01', 'upperLimit': '30.12'}, {'value': '31.09', 'groupId': 'BG001', 'lowerLimit': '26.20', 'upperLimit': '36.81'}, {'value': '29.16', 'groupId': 'BG002', 'lowerLimit': '26.66', 'upperLimit': '34.56'}, {'value': '26.91', 'groupId': 'BG003', 'lowerLimit': '23.95', 'upperLimit': '31.83'}, {'value': '29.87', 'groupId': 'BG004', 'lowerLimit': '25.75', 'upperLimit': '35.99'}, {'value': '30.65', 'groupId': 'BG005', 'lowerLimit': '26.15', 'upperLimit': '35.88'}, {'value': '29.34', 'groupId': 'BG006', 'lowerLimit': '25.20', 'upperLimit': '33.20'}, {'value': '29.06', 'groupId': 'BG007', 'lowerLimit': '25.41', 'upperLimit': '34.28'}, {'value': '29.49', 'groupId': 'BG008', 'lowerLimit': '25.61', 'upperLimit': '34.68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Baseline demographics include all randomized subjects from Phase 1 and Phase 2 by age group. The prespecified immunogenicity analysis and Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values included only subjects 50-64 years old.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-31', 'size': 1291833, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-01T11:09', 'hasProtocol': True}, {'date': '2022-12-29', 'size': 1212012, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-01T11:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple (Participant, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 835}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2022-02-23', 'resultsFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-25', 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group', 'timeFrame': '7 days after vaccination', 'description': 'Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group'}, {'measure': 'Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group', 'timeFrame': '7 days after vaccination', 'description': 'Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain'}, {'measure': 'Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group', 'timeFrame': '1 month after vaccination', 'description': 'Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.'}, {'measure': 'Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)', 'timeFrame': '6 months after vaccination', 'description': 'Percentage of participants with SAEs and NOCIs'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values', 'timeFrame': '1 month after vaccination', 'description': 'Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in \\>5% of Subjects Aged 50 to 64 Years'}, {'measure': 'VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)', 'timeFrame': '1 month after vaccination', 'description': 'Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24'}, {'measure': 'VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)', 'timeFrame': '1 month after vaccination', 'description': 'Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Vaccines']}, 'referencesModule': {'references': [{'pmid': '38061367', 'type': 'RESULT', 'citation': 'Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK. Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. Lancet Infect Dis. 2024 Mar;24(3):308-318. doi: 10.1016/S1473-3099(23)00572-8. Epub 2023 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.', 'detailedDescription': 'The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to PCV20 in adults aged 50 to 64 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female age 18 to 49 years (inclusive) for the Phase 1 group, or 50 to 64 years (inclusive) for the Phase 2 group at the time of enrollment into the study.\n* Able and willing to complete the informed consent process.\n* Available for clinical follow-up through the last study visit at 6 months after the study vaccination.\n* In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the investigator.\n* Screening laboratory values must be within the central laboratory normal limits prior to study enrollment. Minor abnormalities are considered acceptable if not clinically significant.\n* Willing to have blood samples collected, stored indefinitely, and used for research purposes.\n* Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.\n* Negative pregnancy test (urine and serum) for women of childbearing potential.\n\nExclusion Criteria:\n\n* Previous pneumococcal disease (either confirmed or by self-reporting).\n* Previous receipt of a licensed or investigational pneumococcal vaccine.\n* Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.\n* Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Day 29.\n* Physical examination indicating any clinically significant medical condition.\n* Body Temperature \\> 38.0°C (\\> 100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).\n* Seropositive to HIV, HCV, or HBsAg.\n* History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.\n* Female who is breast-feeding or planning to become pregnant during study participation.\n* Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.\n* Any other chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.\n* Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.\n* Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.\n* Received systemic corticosteroids for ≥ 14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.\n* Receiving immunosuppressive therapy.\n* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer."}, 'identificationModule': {'nctId': 'NCT05266456', 'briefTitle': 'Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vaxcyte, Inc.'}, 'officialTitle': 'A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years', 'orgStudyIdInfo': {'id': 'VAX24-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VAX-24 Low Dose', 'description': 'Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.', 'interventionNames': ['Biological: 24 valent pneumococcal conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'VAX-24 Mid Dose', 'description': 'Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.', 'interventionNames': ['Biological: 24 valent pneumococcal conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'VAX-24 Mixed Dose', 'description': 'Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.', 'interventionNames': ['Biological: 24 valent pneumococcal conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCV20', 'description': 'Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.', 'interventionNames': ['Biological: 20 valent pneumococcal conjugate vaccine']}], 'interventions': [{'name': '24 valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1', 'armGroupLabels': ['VAX-24 Low Dose', 'VAX-24 Mid Dose', 'VAX-24 Mixed Dose']}, {'name': '20 valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1', 'armGroupLabels': ['PCV20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'CenExel RCA', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Clinical Research', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Johnson County Clin-Trials', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Acellacare of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29405', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '76904', 'city': 'San Angelo', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 31.46377, 'lon': -100.43704}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Clinical Development', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vaxcyte, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.', 'ipdSharing': 'YES', 'description': "Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.", 'accessCriteria': 'Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vaxcyte, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}