Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-30 @ 12:27 AM
Study NCT ID:
NCT05420961
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2022-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011018', 'term': 'Pneumonia, Pneumococcal'}], 'ancestors': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.', 'description': 'The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 231, 'otherNumAffected': 107, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 119, 'otherNumAffected': 66, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 176, 'otherNumAffected': 85, 'seriousNumAtRisk': 174, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 52, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 106, 'otherNumAffected': 51, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 82, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 72, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 46, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortoenteric fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}, {'value': '9.4', 'groupId': 'OG003'}, {'value': '7.6', 'groupId': 'OG004'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}, {'value': '41.4', 'groupId': 'OG002'}, {'value': '47.1', 'groupId': 'OG003'}, {'value': '43.8', 'groupId': 'OG004'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '4.6', 'groupId': 'OG002'}, {'value': '16.5', 'groupId': 'OG003'}, {'value': '10.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study vaccination were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '19.0', 'groupId': 'OG002'}, {'value': '12.9', 'groupId': 'OG003'}, {'value': '21.9', 'groupId': 'OG004'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}, {'value': '11.8', 'groupId': 'OG003'}, {'value': '8.6', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '9.4', 'groupId': 'OG003'}, {'value': '8.6', 'groupId': 'OG004'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study vaccination were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~180 days', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study vaccination were analyzed.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '262.1', 'groupId': 'OG000', 'lowerLimit': '224.0', 'upperLimit': '306.8'}, {'value': '226.3', 'groupId': 'OG001', 'lowerLimit': '182.0', 'upperLimit': '281.4'}, {'value': '391.1', 'groupId': 'OG002', 'lowerLimit': '332.8', 'upperLimit': '459.6'}, {'value': '583.1', 'groupId': 'OG003', 'lowerLimit': '453.5', 'upperLimit': '749.6'}, {'value': '318.3', 'groupId': 'OG004', 'lowerLimit': '250.0', 'upperLimit': '405.3'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1653.5', 'groupId': 'OG000', 'lowerLimit': '1347.2', 'upperLimit': '2029.4'}, {'value': '2076.1', 'groupId': 'OG001', 'lowerLimit': '1571.4', 'upperLimit': '2742.8'}, {'value': '3624.0', 'groupId': 'OG002', 'lowerLimit': '3099.2', 'upperLimit': '4237.7'}, {'value': '1812.3', 'groupId': 'OG003', 'lowerLimit': '1226.6', 'upperLimit': '2677.6'}, {'value': '2097.3', 'groupId': 'OG004', 'lowerLimit': '1693.4', 'upperLimit': '2597.6'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2184.4', 'groupId': 'OG000', 'lowerLimit': '1891.4', 'upperLimit': '2522.8'}, {'value': '1750.3', 'groupId': 'OG001', 'lowerLimit': '1404.7', 'upperLimit': '2181.0'}, {'value': '3129.8', 'groupId': 'OG002', 'lowerLimit': '2609.9', 'upperLimit': '3753.3'}, {'value': '4057.0', 'groupId': 'OG003', 'lowerLimit': '3211.2', 'upperLimit': '5125.6'}, {'value': '2051.3', 'groupId': 'OG004', 'lowerLimit': '1630.2', 'upperLimit': '2581.0'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1513.8', 'groupId': 'OG000', 'lowerLimit': '1318.4', 'upperLimit': '1738.1'}, {'value': '2022.9', 'groupId': 'OG001', 'lowerLimit': '1634.1', 'upperLimit': '2504.3'}, {'value': '2528.9', 'groupId': 'OG002', 'lowerLimit': '2201.7', 'upperLimit': '2904.9'}, {'value': '3241.5', 'groupId': 'OG003', 'lowerLimit': '2646.0', 'upperLimit': '3971.0'}, {'value': '1533.8', 'groupId': 'OG004', 'lowerLimit': '1272.4', 'upperLimit': '1848.9'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1983.8', 'groupId': 'OG000', 'lowerLimit': '1698.3', 'upperLimit': '2317.4'}, {'value': '1595.6', 'groupId': 'OG001', 'lowerLimit': '1227.1', 'upperLimit': '2074.6'}, {'value': '4389.2', 'groupId': 'OG002', 'lowerLimit': '3541.1', 'upperLimit': '5440.3'}, {'value': '2524.0', 'groupId': 'OG003', 'lowerLimit': '1834.5', 'upperLimit': '3472.5'}, {'value': '1913.5', 'groupId': 'OG004', 'lowerLimit': '1453.5', 'upperLimit': '2519.0'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4311.9', 'groupId': 'OG000', 'lowerLimit': '3625.1', 'upperLimit': '5128.9'}, {'value': '3397.2', 'groupId': 'OG001', 'lowerLimit': '2665.3', 'upperLimit': '4330.0'}, {'value': '8162.9', 'groupId': 'OG002', 'lowerLimit': '6407.2', 'upperLimit': '10399.7'}, {'value': '8761.9', 'groupId': 'OG003', 'lowerLimit': '6157.4', 'upperLimit': '12468.1'}, {'value': '4654.3', 'groupId': 'OG004', 'lowerLimit': '3532.1', 'upperLimit': '6133.1'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1273.0', 'groupId': 'OG000', 'lowerLimit': '1115.1', 'upperLimit': '1453.3'}, {'value': '345.8', 'groupId': 'OG001', 'lowerLimit': '250.5', 'upperLimit': '477.5'}, {'value': '2320.1', 'groupId': 'OG002', 'lowerLimit': '1987.3', 'upperLimit': '2708.7'}, {'value': '2723.2', 'groupId': 'OG003', 'lowerLimit': '2197.4', 'upperLimit': '3374.8'}, {'value': '1486.8', 'groupId': 'OG004', 'lowerLimit': '1230.5', 'upperLimit': '1796.6'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3805.1', 'groupId': 'OG000', 'lowerLimit': '3324.0', 'upperLimit': '4356.0'}, {'value': '2176.5', 'groupId': 'OG001', 'lowerLimit': '1809.6', 'upperLimit': '2617.9'}, {'value': '7214.4', 'groupId': 'OG002', 'lowerLimit': '6062.9', 'upperLimit': '8584.6'}, {'value': '6482.5', 'groupId': 'OG003', 'lowerLimit': '4908.9', 'upperLimit': '8560.7'}, {'value': '4054.5', 'groupId': 'OG004', 'lowerLimit': '3389.4', 'upperLimit': '4850.2'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1986.2', 'groupId': 'OG000', 'lowerLimit': '1637.7', 'upperLimit': '2408.9'}, {'value': '467.5', 'groupId': 'OG001', 'lowerLimit': '337.0', 'upperLimit': '648.5'}, {'value': '3976.8', 'groupId': 'OG002', 'lowerLimit': '3360.7', 'upperLimit': '4705.8'}, {'value': '1797.6', 'groupId': 'OG003', 'lowerLimit': '1136.2', 'upperLimit': '2843.9'}, {'value': '2564.0', 'groupId': 'OG004', 'lowerLimit': '1959.1', 'upperLimit': '3355.6'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1998.5', 'groupId': 'OG000', 'lowerLimit': '1696.9', 'upperLimit': '2353.8'}, {'value': '335.6', 'groupId': 'OG001', 'lowerLimit': '228.9', 'upperLimit': '491.8'}, {'value': '2846.6', 'groupId': 'OG002', 'lowerLimit': '2411.0', 'upperLimit': '3360.8'}, {'value': '1736.6', 'groupId': 'OG003', 'lowerLimit': '1367.1', 'upperLimit': '2206.1'}, {'value': '2373.0', 'groupId': 'OG004', 'lowerLimit': '1905.4', 'upperLimit': '2955.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '981.8', 'groupId': 'OG000', 'lowerLimit': '782.4', 'upperLimit': '1232.1'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '120.1'}, {'value': '2252.6', 'groupId': 'OG002', 'lowerLimit': '2120.5', 'upperLimit': '3072.9'}, {'value': '1402.5', 'groupId': 'OG003', 'lowerLimit': '912.2', 'upperLimit': '2156.4'}, {'value': '1235.3', 'groupId': 'OG004', 'lowerLimit': '948.3', 'upperLimit': '1609.2'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4184.9', 'groupId': 'OG000', 'lowerLimit': '3548.3', 'upperLimit': '4935.6'}, {'value': '877.2', 'groupId': 'OG001', 'lowerLimit': '616.2', 'upperLimit': '1248.7'}, {'value': '6185.2', 'groupId': 'OG002', 'lowerLimit': '5179.3', 'upperLimit': '7386.6'}, {'value': '1668.2', 'groupId': 'OG003', 'lowerLimit': '1234.4', 'upperLimit': '2254.5'}, {'value': '4328.6', 'groupId': 'OG004', 'lowerLimit': '3378.7', 'upperLimit': '5545.7'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2307.8', 'groupId': 'OG000', 'lowerLimit': '1878.4', 'upperLimit': '2835.4'}, {'value': '539.6', 'groupId': 'OG001', 'lowerLimit': '371.1', 'upperLimit': '784.6'}, {'value': '4334.4', 'groupId': 'OG002', 'lowerLimit': '3563.8', 'upperLimit': '5271.5'}, {'value': '1470.4', 'groupId': 'OG003', 'lowerLimit': '978.6', 'upperLimit': '2209.3'}, {'value': '2191.9', 'groupId': 'OG004', 'lowerLimit': '1573.2', 'upperLimit': '3053.9'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3060.5', 'groupId': 'OG000', 'lowerLimit': '2633.8', 'upperLimit': '3556.3'}, {'value': '392.3', 'groupId': 'OG001', 'lowerLimit': '301.3', 'upperLimit': '510.8'}, {'value': '4626.5', 'groupId': 'OG002', 'lowerLimit': '3861.8', 'upperLimit': '5542.6'}, {'value': '832.8', 'groupId': 'OG003', 'lowerLimit': '604.3', 'upperLimit': '1147.6'}, {'value': '2477.0', 'groupId': 'OG004', 'lowerLimit': '1887.2', 'upperLimit': '3251.2'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3599.8', 'groupId': 'OG000', 'lowerLimit': '3134.5', 'upperLimit': '4134.3'}, {'value': '939.6', 'groupId': 'OG001', 'lowerLimit': '693.7', 'upperLimit': '1272.6'}, {'value': '5963.8', 'groupId': 'OG002', 'lowerLimit': '5036.6', 'upperLimit': '7061.7'}, {'value': '4367.3', 'groupId': 'OG003', 'lowerLimit': '3372.5', 'upperLimit': '5655.7'}, {'value': '3836.7', 'groupId': 'OG004', 'lowerLimit': '3063.4', 'upperLimit': '4805.1'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2847.4', 'groupId': 'OG000', 'lowerLimit': '2433.3', 'upperLimit': '3331.8'}, {'value': '1058.9', 'groupId': 'OG001', 'lowerLimit': '829.9', 'upperLimit': '1351.1'}, {'value': '6005.5', 'groupId': 'OG002', 'lowerLimit': '4919.8', 'upperLimit': '7330.8'}, {'value': '3393.9', 'groupId': 'OG003', 'lowerLimit': '2536.9', 'upperLimit': '4540.5'}, {'value': '2433.4', 'groupId': 'OG004', 'lowerLimit': '1880.5', 'upperLimit': '3148.9'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2363.9', 'groupId': 'OG000', 'lowerLimit': '1857.4', 'upperLimit': '3008.5'}, {'value': '310.2', 'groupId': 'OG001', 'lowerLimit': '202.1', 'upperLimit': '476.0'}, {'value': '4253.4', 'groupId': 'OG002', 'lowerLimit': '3417.6', 'upperLimit': '5293.5'}, {'value': '433.6', 'groupId': 'OG003', 'lowerLimit': '247.5', 'upperLimit': '759.5'}, {'value': '3967.2', 'groupId': 'OG004', 'lowerLimit': '2764.8', 'upperLimit': '5692.7'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '673.2', 'groupId': 'OG000', 'lowerLimit': '517.1', 'upperLimit': '876.4'}, {'value': '153.0', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '237.1'}, {'value': '1530.7', 'groupId': 'OG002', 'lowerLimit': '1196.5', 'upperLimit': '1958.3'}, {'value': '203.9', 'groupId': 'OG003', 'lowerLimit': '127.6', 'upperLimit': '325.6'}, {'value': '844.0', 'groupId': 'OG004', 'lowerLimit': '608.2', 'upperLimit': '1171.4'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1822.6', 'groupId': 'OG000', 'lowerLimit': '1411.6', 'upperLimit': '2353.3'}, {'value': '106.6', 'groupId': 'OG001', 'lowerLimit': '69.7', 'upperLimit': '162.9'}, {'value': '2746.1', 'groupId': 'OG002', 'lowerLimit': '2257.9', 'upperLimit': '3339.9'}, {'value': '48.5', 'groupId': 'OG003', 'lowerLimit': '28.6', 'upperLimit': '82.1'}, {'value': '2041.5', 'groupId': 'OG004', 'lowerLimit': '1500.8', 'upperLimit': '2777.1'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3018.4', 'groupId': 'OG000', 'lowerLimit': '2473.6', 'upperLimit': '3683.3'}, {'value': '113.2', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '172.1'}, {'value': '4413.5', 'groupId': 'OG002', 'lowerLimit': '3530.2', 'upperLimit': '5517.7'}, {'value': '171.8', 'groupId': 'OG003', 'lowerLimit': '99.9', 'upperLimit': '295.6'}, {'value': '3285.5', 'groupId': 'OG004', 'lowerLimit': '2485.0', 'upperLimit': '4343.8'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6703.1', 'groupId': 'OG000', 'lowerLimit': '5732.7', 'upperLimit': '7837.8'}, {'value': '1019.1', 'groupId': 'OG001', 'lowerLimit': '739.9', 'upperLimit': '1403.7'}, {'value': '8143.5', 'groupId': 'OG002', 'lowerLimit': '6761.4', 'upperLimit': '9808.1'}, {'value': '1527.7', 'groupId': 'OG003', 'lowerLimit': '1169.5', 'upperLimit': '1995.5'}, {'value': '5836.8', 'groupId': 'OG004', 'lowerLimit': '4693.6', 'upperLimit': '7258.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 Days post-vaccination', 'description': 'OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '0.99'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '0.97'}, {'value': '0.89', 'groupId': 'OG002', 'lowerLimit': '0.77', 'upperLimit': '1.03'}, {'value': '1.58', 'groupId': 'OG003', 'lowerLimit': '1.25', 'upperLimit': '2.00'}, {'value': '0.85', 'groupId': 'OG004', 'lowerLimit': '0.70', 'upperLimit': '1.03'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.69', 'groupId': 'OG000', 'lowerLimit': '3.72', 'upperLimit': '5.90'}, {'value': '7.69', 'groupId': 'OG001', 'lowerLimit': '5.60', 'upperLimit': '10.57'}, {'value': '7.81', 'groupId': 'OG002', 'lowerLimit': '6.30', 'upperLimit': '9.68'}, {'value': '5.24', 'groupId': 'OG003', 'lowerLimit': '3.62', 'upperLimit': '7.56'}, {'value': '5.48', 'groupId': 'OG004', 'lowerLimit': '4.27', 'upperLimit': '7.03'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.71', 'groupId': 'OG000', 'lowerLimit': '4.89', 'upperLimit': '6.68'}, {'value': '6.45', 'groupId': 'OG001', 'lowerLimit': '5.08', 'upperLimit': '8.19'}, {'value': '5.65', 'groupId': 'OG002', 'lowerLimit': '4.75', 'upperLimit': '6.73'}, {'value': '8.34', 'groupId': 'OG003', 'lowerLimit': '6.57', 'upperLimit': '10.59'}, {'value': '5.07', 'groupId': 'OG004', 'lowerLimit': '4.12', 'upperLimit': '6.23'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.54', 'groupId': 'OG000', 'lowerLimit': '7.33', 'upperLimit': '9.95'}, {'value': '11.97', 'groupId': 'OG001', 'lowerLimit': '9.40', 'upperLimit': '15.24'}, {'value': '9.12', 'groupId': 'OG002', 'lowerLimit': '7.70', 'upperLimit': '10.81'}, {'value': '12.41', 'groupId': 'OG003', 'lowerLimit': '9.57', 'upperLimit': '16.11'}, {'value': '8.06', 'groupId': 'OG004', 'lowerLimit': '6.50', 'upperLimit': '9.98'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.41', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '5.28'}, {'value': '4.33', 'groupId': 'OG001', 'lowerLimit': '3.37', 'upperLimit': '5.56'}, {'value': '5.38', 'groupId': 'OG002', 'lowerLimit': '4.34', 'upperLimit': '6.66'}, {'value': '2.87', 'groupId': 'OG003', 'lowerLimit': '2.12', 'upperLimit': '3.87'}, {'value': '3.08', 'groupId': 'OG004', 'lowerLimit': '2.36', 'upperLimit': '4.01'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.36', 'groupId': 'OG000', 'lowerLimit': '11.22', 'upperLimit': '15.91'}, {'value': '12.72', 'groupId': 'OG001', 'lowerLimit': '10.37', 'upperLimit': '15.61'}, {'value': '15.04', 'groupId': 'OG002', 'lowerLimit': '12.31', 'upperLimit': '18.37'}, {'value': '13.92', 'groupId': 'OG003', 'lowerLimit': '10.23', 'upperLimit': '18.94'}, {'value': '9.66', 'groupId': 'OG004', 'lowerLimit': '7.53', 'upperLimit': '12.40'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.58', 'groupId': 'OG000', 'lowerLimit': '8.21', 'upperLimit': '11.17'}, {'value': '3.56', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '4.62'}, {'value': '11.29', 'groupId': 'OG002', 'lowerLimit': '9.28', 'upperLimit': '13.73'}, {'value': '14.47', 'groupId': 'OG003', 'lowerLimit': '10.86', 'upperLimit': '19.27'}, {'value': '7.48', 'groupId': 'OG004', 'lowerLimit': '5.87', 'upperLimit': '9.53'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.06', 'groupId': 'OG000', 'lowerLimit': '5.92', 'upperLimit': '8.43'}, {'value': '3.59', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': '4.55'}, {'value': '8.48', 'groupId': 'OG002', 'lowerLimit': '6.89', 'upperLimit': '10.44'}, {'value': '7.32', 'groupId': 'OG003', 'lowerLimit': '5.47', 'upperLimit': '9.78'}, {'value': '4.15', 'groupId': 'OG004', 'lowerLimit': '3.23', 'upperLimit': '5.34'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '7.99', 'upperLimit': '12.18'}, {'value': '2.77', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '3.63'}, {'value': '18.21', 'groupId': 'OG002', 'lowerLimit': '14.30', 'upperLimit': '23.18'}, {'value': '7.29', 'groupId': 'OG003', 'lowerLimit': '4.94', 'upperLimit': '10.74'}, {'value': '10.03', 'groupId': 'OG004', 'lowerLimit': '7.21', 'upperLimit': '13.98'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.16', 'groupId': 'OG000', 'lowerLimit': '6.09', 'upperLimit': '8.42'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.65', 'upperLimit': '2.58'}, {'value': '9.13', 'groupId': 'OG002', 'lowerLimit': '7.44', 'upperLimit': '11.22'}, {'value': '3.95', 'groupId': 'OG003', 'lowerLimit': '2.98', 'upperLimit': '5.23'}, {'value': '4.78', 'groupId': 'OG004', 'lowerLimit': '3.79', 'upperLimit': '6.03'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '1.81'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.55'}, {'value': '1.91', 'groupId': 'OG002', 'lowerLimit': '1.44', 'upperLimit': '2.53'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.65', 'upperLimit': '1.56'}, {'value': '0.96', 'groupId': 'OG004', 'lowerLimit': '0.70', 'upperLimit': '1.31'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.35', 'groupId': 'OG000', 'lowerLimit': '13.45', 'upperLimit': '19.88'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.19', 'upperLimit': '2.05'}, {'value': '20.24', 'groupId': 'OG002', 'lowerLimit': '15.92', 'upperLimit': '25.75'}, {'value': '2.15', 'groupId': 'OG003', 'lowerLimit': '1.52', 'upperLimit': '3.03'}, {'value': '11.16', 'groupId': 'OG004', 'lowerLimit': '7.91', 'upperLimit': '15.75'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.08', 'groupId': 'OG000', 'lowerLimit': '9.01', 'upperLimit': '13.62'}, {'value': '3.25', 'groupId': 'OG001', 'lowerLimit': '2.37', 'upperLimit': '4.45'}, {'value': '16.67', 'groupId': 'OG002', 'lowerLimit': '12.78', 'upperLimit': '21.76'}, {'value': '4.31', 'groupId': 'OG003', 'lowerLimit': '2.91', 'upperLimit': '6.38'}, {'value': '6.51', 'groupId': 'OG004', 'lowerLimit': '4.72', 'upperLimit': '8.99'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.69', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '5.87'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '0.48'}, {'value': '4.04', 'groupId': 'OG002', 'lowerLimit': '3.19', 'upperLimit': '5.10'}, {'value': '0.30', 'groupId': 'OG003', 'lowerLimit': '0.22', 'upperLimit': '0.41'}, {'value': '2.46', 'groupId': 'OG004', 'lowerLimit': '1.78', 'upperLimit': '3.41'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.20', 'groupId': 'OG000', 'lowerLimit': '11.18', 'upperLimit': '15.58'}, {'value': '2.68', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '3.46'}, {'value': '14.96', 'groupId': 'OG002', 'lowerLimit': '12.37', 'upperLimit': '18.08'}, {'value': '7.23', 'groupId': 'OG003', 'lowerLimit': '5.26', 'upperLimit': '9.92'}, {'value': '9.92', 'groupId': 'OG004', 'lowerLimit': '7.86', 'upperLimit': '12.53'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.83', 'groupId': 'OG000', 'lowerLimit': '12.37', 'upperLimit': '17.77'}, {'value': '4.93', 'groupId': 'OG001', 'lowerLimit': '3.83', 'upperLimit': '6.36'}, {'value': '22.21', 'groupId': 'OG002', 'lowerLimit': '17.77', 'upperLimit': '27.75'}, {'value': '10.73', 'groupId': 'OG003', 'lowerLimit': '7.48', 'upperLimit': '15.41'}, {'value': '12.16', 'groupId': 'OG004', 'lowerLimit': '8.99', 'upperLimit': '16.46'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.38', 'groupId': 'OG000', 'lowerLimit': '4.19', 'upperLimit': '6.90'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '1.02'}, {'value': '6.03', 'groupId': 'OG002', 'lowerLimit': '4.55', 'upperLimit': '7.99'}, {'value': '0.62', 'groupId': 'OG003', 'lowerLimit': '0.43', 'upperLimit': '0.90'}, {'value': '4.25', 'groupId': 'OG004', 'lowerLimit': '2.88', 'upperLimit': '6.26'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.66', 'groupId': 'OG000', 'lowerLimit': '5.53', 'upperLimit': '8.03'}, {'value': '2.61', 'groupId': 'OG001', 'lowerLimit': '1.96', 'upperLimit': '3.48'}, {'value': '6.00', 'groupId': 'OG002', 'lowerLimit': '4.91', 'upperLimit': '7.33'}, {'value': '2.31', 'groupId': 'OG003', 'lowerLimit': '1.75', 'upperLimit': '3.06'}, {'value': '5.05', 'groupId': 'OG004', 'lowerLimit': '3.90', 'upperLimit': '6.54'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.05', 'groupId': 'OG000', 'lowerLimit': '7.59', 'upperLimit': '13.32'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.61'}, {'value': '7.48', 'groupId': 'OG002', 'lowerLimit': '5.45', 'upperLimit': '10.46'}, {'value': '0.31', 'groupId': 'OG003', 'lowerLimit': '0.23', 'upperLimit': '0.42'}, {'value': '6.12', 'groupId': 'OG004', 'lowerLimit': '3.84', 'upperLimit': '9.75'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.48', 'groupId': 'OG000', 'lowerLimit': '3.66', 'upperLimit': '5.48'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.47'}, {'value': '3.58', 'groupId': 'OG002', 'lowerLimit': '2.87', 'upperLimit': '4.46'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.24', 'upperLimit': '0.44'}, {'value': '3.66', 'groupId': 'OG004', 'lowerLimit': '2.64', 'upperLimit': '5.08'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.31', 'groupId': 'OG000', 'lowerLimit': '21.60', 'upperLimit': '32.04'}, {'value': '1.45', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.78'}, {'value': '24.55', 'groupId': 'OG002', 'lowerLimit': '20.09', 'upperLimit': '30.01'}, {'value': '1.45', 'groupId': 'OG003', 'lowerLimit': '1.17', 'upperLimit': '1.80'}, {'value': '18.15', 'groupId': 'OG004', 'lowerLimit': '13.61', 'upperLimit': '24.21'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 Days post-vaccination', 'description': 'The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '5.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '5.3'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '7.6'}, {'value': '7.5', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '10.5'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '3.6', 'upperLimit': '7.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '7.7'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '10.3'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '5.3'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '2.4'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '7.4'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '5.1'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '5.4'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '5.9'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '5.8'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '5.3'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '4.4'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '3.3'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '4.7'}, {'value': '2.5', 'groupId': 'OG004', 'lowerLimit': '1.8', 'upperLimit': '3.3'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '9.0'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '10.6'}, {'value': '26.3', 'groupId': 'OG002', 'lowerLimit': '17.7', 'upperLimit': '39.2'}, {'value': '14.8', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '25.1'}, {'value': '7.5', 'groupId': 'OG004', 'lowerLimit': '4.9', 'upperLimit': '11.4'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.6'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.4'}, {'value': '6.3', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '8.4'}, {'value': '9.2', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': '15.3'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '3.7'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.4'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.0'}, {'value': '16.6', 'groupId': 'OG002', 'lowerLimit': '12.2', 'upperLimit': '22.7'}, {'value': '18.6', 'groupId': 'OG003', 'lowerLimit': '11.9', 'upperLimit': '29.1'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '5.3'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.7'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.7'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '4.7', 'upperLimit': '7.4'}, {'value': '6.8', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '9.8'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '4.5'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '5.4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.2'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '12.7', 'upperLimit': '23.0'}, {'value': '11.8', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '18.6'}, {'value': '4.7', 'groupId': 'OG004', 'lowerLimit': '3.4', 'upperLimit': '6.5'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '8.2'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.7'}, {'value': '21.0', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '30.4'}, {'value': '9.2', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '14.4'}, {'value': '9.5', 'groupId': 'OG004', 'lowerLimit': '6.2', 'upperLimit': '14.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '15.4'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '82.2', 'groupId': 'OG002', 'lowerLimit': '62.9', 'upperLimit': '107.4'}, {'value': '41.9', 'groupId': 'OG003', 'lowerLimit': '26.1', 'upperLimit': '67.2'}, {'value': '13.7', 'groupId': 'OG004', 'lowerLimit': '9.0', 'upperLimit': '20.8'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '7.4'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.5'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '11.8'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '4.5'}, {'value': '7.2', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '11.2'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '10.9'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.7'}, {'value': '30.6', 'groupId': 'OG002', 'lowerLimit': '22.5', 'upperLimit': '41.5'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '8.5', 'upperLimit': '18.8'}, {'value': '11.6', 'groupId': 'OG004', 'lowerLimit': '8.1', 'upperLimit': '16.4'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '8.5'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.3'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '12.4'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '2.7'}, {'value': '7.2', 'groupId': 'OG004', 'lowerLimit': '5.5', 'upperLimit': '9.6'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.1'}, {'value': '13.5', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '19.2'}, {'value': '8.1', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': '11.7'}, {'value': '6.5', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '9.3'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '16.0'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '8.3'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '6.1'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '11.6'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.9'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '13.5', 'upperLimit': '26.9'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '4.9'}, {'value': '16.3', 'groupId': 'OG004', 'lowerLimit': '10.3', 'upperLimit': '25.7'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '28.1'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '6.0'}, {'value': '35.5', 'groupId': 'OG002', 'lowerLimit': '25.9', 'upperLimit': '48.6'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '3.5', 'upperLimit': '7.6'}, {'value': '26.1', 'groupId': 'OG004', 'lowerLimit': '17.5', 'upperLimit': '38.9'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '34.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.3'}, {'value': '31.1', 'groupId': 'OG002', 'lowerLimit': '22.8', 'upperLimit': '42.6'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '1.3'}, {'value': '39.5', 'groupId': 'OG004', 'lowerLimit': '27.4', 'upperLimit': '56.9'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '22.3'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.2'}, {'value': '35.6', 'groupId': 'OG002', 'lowerLimit': '24.8', 'upperLimit': '51.2'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '2.6'}, {'value': '30.5', 'groupId': 'OG004', 'lowerLimit': '19.1', 'upperLimit': '48.6'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '7.4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.2'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '9.2'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.8'}, {'value': '5.7', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '7.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': '62.6'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '65.4'}, {'value': '64.1', 'groupId': 'OG002', 'lowerLimit': '55.3', 'upperLimit': '72.3'}, {'value': '66.2', 'groupId': 'OG003', 'lowerLimit': '53.7', 'upperLimit': '77.2'}, {'value': '48.7', 'groupId': 'OG004', 'lowerLimit': '37.0', 'upperLimit': '60.4'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '65.4'}, {'value': '58.6', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '69.1'}, {'value': '46.3', 'groupId': 'OG002', 'lowerLimit': '37.7', 'upperLimit': '55.1'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '29.6'}, {'value': '56.2', 'groupId': 'OG004', 'lowerLimit': '45.3', 'upperLimit': '66.7'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '31.7', 'upperLimit': '45.6'}, {'value': '43.1', 'groupId': 'OG001', 'lowerLimit': '33.4', 'upperLimit': '53.3'}, {'value': '44.5', 'groupId': 'OG002', 'lowerLimit': '36.3', 'upperLimit': '53.0'}, {'value': '49.3', 'groupId': 'OG003', 'lowerLimit': '37.0', 'upperLimit': '61.6'}, {'value': '38.0', 'groupId': 'OG004', 'lowerLimit': '28.1', 'upperLimit': '48.8'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '35.2'}, {'value': '34.6', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '44.6'}, {'value': '33.6', 'groupId': 'OG002', 'lowerLimit': '26.0', 'upperLimit': '41.7'}, {'value': '38.9', 'groupId': 'OG003', 'lowerLimit': '27.6', 'upperLimit': '51.1'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '20.8', 'upperLimit': '40.6'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '61.1'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '64.8'}, {'value': '77.4', 'groupId': 'OG002', 'lowerLimit': '69.0', 'upperLimit': '84.4'}, {'value': '65.6', 'groupId': 'OG003', 'lowerLimit': '52.7', 'upperLimit': '77.1'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '39.5', 'upperLimit': '60.5'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '26.4'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '28.9'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '42.9', 'upperLimit': '61.0'}, {'value': '56.0', 'groupId': 'OG003', 'lowerLimit': '41.3', 'upperLimit': '70.0'}, {'value': '29.4', 'groupId': 'OG004', 'lowerLimit': '20.0', 'upperLimit': '40.3'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '26.8', 'upperLimit': '40.4'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '7.9'}, {'value': '70.2', 'groupId': 'OG002', 'lowerLimit': '62.2', 'upperLimit': '77.4'}, {'value': '74.6', 'groupId': 'OG003', 'lowerLimit': '62.9', 'upperLimit': '84.2'}, {'value': '34.4', 'groupId': 'OG004', 'lowerLimit': '25.0', 'upperLimit': '44.8'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '87', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '28.7'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '12.9'}, {'value': '57.4', 'groupId': 'OG002', 'lowerLimit': '48.6', 'upperLimit': '65.8'}, {'value': '67.9', 'groupId': 'OG003', 'lowerLimit': '53.7', 'upperLimit': '80.1'}, {'value': '39.1', 'groupId': 'OG004', 'lowerLimit': '28.8', 'upperLimit': '50.1'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '53.2'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '7.7'}, {'value': '74.3', 'groupId': 'OG002', 'lowerLimit': '66.5', 'upperLimit': '81.1'}, {'value': '67.6', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '78.2'}, {'value': '49.5', 'groupId': 'OG004', 'lowerLimit': '38.9', 'upperLimit': '60.0'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '61.1'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '20.6'}, {'value': '73.3', 'groupId': 'OG002', 'lowerLimit': '64.8', 'upperLimit': '80.6'}, {'value': '53.8', 'groupId': 'OG003', 'lowerLimit': '41.0', 'upperLimit': '66.3'}, {'value': '59.0', 'groupId': 'OG004', 'lowerLimit': '47.7', 'upperLimit': '69.7'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '93', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000', 'lowerLimit': '55.8', 'upperLimit': '69.4'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '12.5'}, {'value': '93.0', 'groupId': 'OG002', 'lowerLimit': '87.8', 'upperLimit': '96.5'}, {'value': '81.9', 'groupId': 'OG003', 'lowerLimit': '71.1', 'upperLimit': '90.0'}, {'value': '60.2', 'groupId': 'OG004', 'lowerLimit': '49.5', 'upperLimit': '70.2'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '61.9'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '22.3'}, {'value': '70.9', 'groupId': 'OG002', 'lowerLimit': '61.5', 'upperLimit': '79.2'}, {'value': '35.0', 'groupId': 'OG003', 'lowerLimit': '20.6', 'upperLimit': '51.7'}, {'value': '59.7', 'groupId': 'OG004', 'lowerLimit': '46.4', 'upperLimit': '71.9'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '68.3'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '17.5'}, {'value': '84.4', 'groupId': 'OG002', 'lowerLimit': '77.3', 'upperLimit': '90.0'}, {'value': '72.1', 'groupId': 'OG003', 'lowerLimit': '59.9', 'upperLimit': '82.3'}, {'value': '72.0', 'groupId': 'OG004', 'lowerLimit': '60.9', 'upperLimit': '81.3'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '74.9'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '15.2'}, {'value': '70.5', 'groupId': 'OG002', 'lowerLimit': '61.9', 'upperLimit': '78.1'}, {'value': '30.9', 'groupId': 'OG003', 'lowerLimit': '20.2', 'upperLimit': '43.3'}, {'value': '70.9', 'groupId': 'OG004', 'lowerLimit': '60.1', 'upperLimit': '80.2'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000', 'lowerLimit': '30.7', 'upperLimit': '45.2'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '7.0'}, {'value': '74.1', 'groupId': 'OG002', 'lowerLimit': '65.2', 'upperLimit': '81.8'}, {'value': '62.5', 'groupId': 'OG003', 'lowerLimit': '49.5', 'upperLimit': '74.3'}, {'value': '54.4', 'groupId': 'OG004', 'lowerLimit': '42.8', 'upperLimit': '65.7'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '44.9'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '8.1'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '68.5', 'upperLimit': '83.7'}, {'value': '60.9', 'groupId': 'OG003', 'lowerLimit': '48.4', 'upperLimit': '72.4'}, {'value': '46.9', 'groupId': 'OG004', 'lowerLimit': '35.7', 'upperLimit': '58.3'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '67.6'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '31.9'}, {'value': '73.7', 'groupId': 'OG002', 'lowerLimit': '64.8', 'upperLimit': '81.4'}, {'value': '34.2', 'groupId': 'OG003', 'lowerLimit': '19.6', 'upperLimit': '51.4'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '68.2', 'upperLimit': '88.9'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '80.9'}, {'value': '40.4', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '50.2'}, {'value': '80.6', 'groupId': 'OG002', 'lowerLimit': '73.5', 'upperLimit': '86.5'}, {'value': '43.7', 'groupId': 'OG003', 'lowerLimit': '31.9', 'upperLimit': '56.0'}, {'value': '80.9', 'groupId': 'OG004', 'lowerLimit': '71.4', 'upperLimit': '88.2'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '85.7'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '15.2'}, {'value': '81.9', 'groupId': 'OG002', 'lowerLimit': '74.1', 'upperLimit': '88.2'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '13.7'}, {'value': '89.0', 'groupId': 'OG004', 'lowerLimit': '80.2', 'upperLimit': '94.9'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '63.7', 'upperLimit': '77.5'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '15.6'}, {'value': '81.3', 'groupId': 'OG002', 'lowerLimit': '73.7', 'upperLimit': '87.5'}, {'value': '18.0', 'groupId': 'OG003', 'lowerLimit': '9.4', 'upperLimit': '30.0'}, {'value': '82.1', 'groupId': 'OG004', 'lowerLimit': '72.3', 'upperLimit': '89.6'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '62.5'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '14.3'}, {'value': '65.3', 'groupId': 'OG002', 'lowerLimit': '56.9', 'upperLimit': '73.0'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '15.7'}, {'value': '57.6', 'groupId': 'OG004', 'lowerLimit': '46.4', 'upperLimit': '68.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise of Serotype-specific IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '4.0'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '3.7'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '4.3'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '7.4'}, {'value': '2.9', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '3.5'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '7.1'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '10.6'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '4.0'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '3.2'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '3.4', 'upperLimit': '5.7'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '3.8'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.5'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '3.8'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '3.9'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '2.6', 'upperLimit': '4.0'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.7'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.2'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '2.5'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '3.6'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '2.4'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '4.9'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.2'}, {'value': '14.3', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '18.0'}, {'value': '8.5', 'groupId': 'OG003', 'lowerLimit': '6.2', 'upperLimit': '11.6'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '4.6'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.1'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '10.5'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '7.9', 'upperLimit': '13.9'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '3.0'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '15.0'}, {'value': '14.4', 'groupId': 'OG003', 'lowerLimit': '10.3', 'upperLimit': '20.0'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '2.8'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.4'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.6'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '10.6'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '6.8', 'upperLimit': '12.1'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '2.6', 'upperLimit': '3.9'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '5.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '18.9', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '23.4'}, {'value': '10.1', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '13.4'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '5.5'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '4.7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '12.6'}, {'value': '5.6', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '7.2'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '4.3'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '14.2', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '17.9'}, {'value': '8.4', 'groupId': 'OG003', 'lowerLimit': '5.8', 'upperLimit': '12.0'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '4.5'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '14.7'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '19.7', 'upperLimit': '30.3'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '3.0'}, {'value': '16.6', 'groupId': 'OG004', 'lowerLimit': '12.0', 'upperLimit': '22.9'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.2'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '14.9', 'upperLimit': '23.8'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '4.8', 'upperLimit': '8.2'}, {'value': '6.4', 'groupId': 'OG004', 'lowerLimit': '5.0', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '18.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '15.7', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '19.0'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '1.8'}, {'value': '11.9', 'groupId': 'OG004', 'lowerLimit': '9.2', 'upperLimit': '15.4'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.5'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '17.4', 'groupId': 'OG002', 'lowerLimit': '14.3', 'upperLimit': '21.1'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '7.8', 'upperLimit': '14.1'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '5.0'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.4'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '12.2', 'upperLimit': '17.9'}, {'value': '8.5', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '11.4'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '4.8'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '16.5'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.2'}, {'value': '18.9', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '23.4'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '2.7'}, {'value': '13.1', 'groupId': 'OG004', 'lowerLimit': '9.6', 'upperLimit': '17.7'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '10.0'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.5'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '8.9'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '2.9'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '5.4', 'upperLimit': '9.7'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '33.1'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '21.7', 'groupId': 'OG002', 'lowerLimit': '17.3', 'upperLimit': '27.2'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.1'}, {'value': '24.4', 'groupId': 'OG004', 'lowerLimit': '17.1', 'upperLimit': '34.9'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '15.6'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '14.4', 'groupId': 'OG002', 'lowerLimit': '11.9', 'upperLimit': '17.3'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '1.8'}, {'value': '13.0', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '17.0'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '20.3'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '18.7'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.0'}, {'value': '15.7', 'groupId': 'OG004', 'lowerLimit': '11.9', 'upperLimit': '20.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'OG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'OG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'OG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'OG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '49.6'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '28.0', 'upperLimit': '46.2'}, {'value': '40.7', 'groupId': 'OG002', 'lowerLimit': '33.2', 'upperLimit': '48.6'}, {'value': '54.3', 'groupId': 'OG003', 'lowerLimit': '42.9', 'upperLimit': '65.4'}, {'value': '35.4', 'groupId': 'OG004', 'lowerLimit': '26.0', 'upperLimit': '45.6'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '62.8'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '55.6', 'upperLimit': '73.5'}, {'value': '35.9', 'groupId': 'OG002', 'lowerLimit': '28.7', 'upperLimit': '43.7'}, {'value': '27.2', 'groupId': 'OG003', 'lowerLimit': '17.9', 'upperLimit': '38.2'}, {'value': '45.5', 'groupId': 'OG004', 'lowerLimit': '35.4', 'upperLimit': '55.8'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '41.4'}, {'value': '29.9', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '39.1'}, {'value': '37.7', 'groupId': 'OG002', 'lowerLimit': '30.4', 'upperLimit': '45.5'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '23.2', 'upperLimit': '44.7'}, {'value': '37.4', 'groupId': 'OG004', 'lowerLimit': '27.9', 'upperLimit': '47.7'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '30.9'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '47.0'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '26.6'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '23.2', 'upperLimit': '44.7'}, {'value': '19.2', 'groupId': 'OG004', 'lowerLimit': '12.0', 'upperLimit': '28.3'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '32.8', 'upperLimit': '46.1'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '44.4'}, {'value': '78.4', 'groupId': 'OG002', 'lowerLimit': '71.4', 'upperLimit': '84.4'}, {'value': '65.4', 'groupId': 'OG003', 'lowerLimit': '54.0', 'upperLimit': '75.7'}, {'value': '43.4', 'groupId': 'OG004', 'lowerLimit': '33.5', 'upperLimit': '53.8'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '24.9'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '20.3'}, {'value': '72.5', 'groupId': 'OG002', 'lowerLimit': '65.0', 'upperLimit': '79.1'}, {'value': '75.3', 'groupId': 'OG003', 'lowerLimit': '64.5', 'upperLimit': '84.2'}, {'value': '27.3', 'groupId': 'OG004', 'lowerLimit': '18.8', 'upperLimit': '37.1'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '36.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '78.4', 'groupId': 'OG002', 'lowerLimit': '71.4', 'upperLimit': '84.4'}, {'value': '76.5', 'groupId': 'OG003', 'lowerLimit': '65.8', 'upperLimit': '85.2'}, {'value': '26.3', 'groupId': 'OG004', 'lowerLimit': '17.9', 'upperLimit': '36.1'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '38.4'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '14.1'}, {'value': '68.9', 'groupId': 'OG002', 'lowerLimit': '61.2', 'upperLimit': '75.8'}, {'value': '72.8', 'groupId': 'OG003', 'lowerLimit': '61.8', 'upperLimit': '82.1'}, {'value': '36.4', 'groupId': 'OG004', 'lowerLimit': '26.9', 'upperLimit': '46.6'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '52.3'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '76.0', 'upperLimit': '88.1'}, {'value': '80.2', 'groupId': 'OG003', 'lowerLimit': '69.9', 'upperLimit': '88.3'}, {'value': '46.5', 'groupId': 'OG004', 'lowerLimit': '36.4', 'upperLimit': '56.8'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '50.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '72.5', 'groupId': 'OG002', 'lowerLimit': '65.0', 'upperLimit': '79.1'}, {'value': '63.0', 'groupId': 'OG003', 'lowerLimit': '51.5', 'upperLimit': '73.4'}, {'value': '43.4', 'groupId': 'OG004', 'lowerLimit': '33.5', 'upperLimit': '53.8'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '51.4'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.3'}, {'value': '75.4', 'groupId': 'OG002', 'lowerLimit': '68.2', 'upperLimit': '81.8'}, {'value': '60.5', 'groupId': 'OG003', 'lowerLimit': '49.0', 'upperLimit': '71.2'}, {'value': '39.4', 'groupId': 'OG004', 'lowerLimit': '29.7', 'upperLimit': '49.7'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '79.3'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '89.8', 'groupId': 'OG002', 'lowerLimit': '84.2', 'upperLimit': '94.0'}, {'value': '28.4', 'groupId': 'OG003', 'lowerLimit': '18.9', 'upperLimit': '39.5'}, {'value': '77.8', 'groupId': 'OG004', 'lowerLimit': '68.3', 'upperLimit': '85.5'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '50.7', 'upperLimit': '64.2'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '8.5'}, {'value': '80.1', 'groupId': 'OG002', 'lowerLimit': '73.2', 'upperLimit': '85.9'}, {'value': '64.2', 'groupId': 'OG003', 'lowerLimit': '52.8', 'upperLimit': '74.6'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '56.5', 'upperLimit': '75.8'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '87.0'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.3'}, {'value': '84.9', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '90.0'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '23.0'}, {'value': '77.8', 'groupId': 'OG004', 'lowerLimit': '68.3', 'upperLimit': '85.5'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '55.7'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '6.0'}, {'value': '83.8', 'groupId': 'OG002', 'lowerLimit': '77.4', 'upperLimit': '89.1'}, {'value': '74.1', 'groupId': 'OG003', 'lowerLimit': '63.1', 'upperLimit': '83.2'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '34.5', 'upperLimit': '54.8'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '43.3'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '83.2', 'groupId': 'OG002', 'lowerLimit': '76.7', 'upperLimit': '88.6'}, {'value': '69.1', 'groupId': 'OG003', 'lowerLimit': '57.9', 'upperLimit': '78.9'}, {'value': '49.5', 'groupId': 'OG004', 'lowerLimit': '39.3', 'upperLimit': '59.7'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '83.0'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '25.2'}, {'value': '86.7', 'groupId': 'OG002', 'lowerLimit': '80.6', 'upperLimit': '91.5'}, {'value': '21.0', 'groupId': 'OG003', 'lowerLimit': '12.7', 'upperLimit': '31.5'}, {'value': '77.8', 'groupId': 'OG004', 'lowerLimit': '68.3', 'upperLimit': '85.5'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '58.1', 'upperLimit': '71.2'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '35.5'}, {'value': '60.5', 'groupId': 'OG002', 'lowerLimit': '52.6', 'upperLimit': '67.9'}, {'value': '21.0', 'groupId': 'OG003', 'lowerLimit': '12.7', 'upperLimit': '31.5'}, {'value': '64.6', 'groupId': 'OG004', 'lowerLimit': '54.4', 'upperLimit': '74.0'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '89.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '88.0', 'groupId': 'OG002', 'lowerLimit': '82.1', 'upperLimit': '92.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.5'}, {'value': '83.8', 'groupId': 'OG004', 'lowerLimit': '75.1', 'upperLimit': '90.5'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '84.9'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.3'}, {'value': '84.4', 'groupId': 'OG002', 'lowerLimit': '78.0', 'upperLimit': '89.6'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '20.0'}, {'value': '80.8', 'groupId': 'OG004', 'lowerLimit': '71.7', 'upperLimit': '88.0'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '88.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '76.0', 'upperLimit': '88.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '4.5'}, {'value': '84.8', 'groupId': 'OG004', 'lowerLimit': '76.2', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'FG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'FG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'FG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'FG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '176'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '106'}]}, {'type': 'Day 1 - Vaccinated With V116', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'comment': 'This participant inadvertently received V116. Per protocol this participant was included in the Cohort 1 V116 group.', 'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '174'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '105'}]}, {'type': 'Day 1 - Vaccinated With PCV15', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Day 1 - Vaccinated With PPSV23', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This participant inadvertently received PPSV23. Per protocol this participant was excluded from the all participants as treated (APaT) population because the actual intervention received was not one of the two designated interventions in Cohort 1.', 'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '173'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Randomized by mistake without study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '717 adults were randomized to 1 of 3 cohorts. One participant randomized to receive PCV15 in Cohort 1 incorrectly received V116. Per protocol the participant was included in the Cohort 1 V116 group. One participant randomized to receive PCV15 in Cohort 1 incorrectly received PPSV23 (intervention for Cohort 2). Per protocol this participant was excluded from the all participants as treated population because the actual intervention received was not 1 of the 2 designated interventions in Cohort 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}, {'value': '717', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: V116', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) prior to the enrollment.'}, {'id': 'BG001', 'title': 'Cohort 1: PCV15', 'description': 'Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.'}, {'id': 'BG002', 'title': 'Cohort 2: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.'}, {'id': 'BG003', 'title': 'Cohort 2: PPSV23', 'description': 'Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.'}, {'id': 'BG004', 'title': 'Cohort 3: V116', 'description': 'Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '65.4', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '65.4', 'spread': '6.6', 'groupId': 'BG003'}, {'value': '71.0', 'spread': '7.6', 'groupId': 'BG004'}, {'value': '67.9', 'spread': '7.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '383', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '334', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '103', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}, {'value': '612', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '236', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '459', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-06', 'size': 760175, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-04T11:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 717}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2022-06-13', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-04', 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs)', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.'}, {'measure': 'Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)', 'timeFrame': 'Up to ~180 days', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.'}, {'measure': 'Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)', 'timeFrame': '30 Days post-vaccination', 'description': 'OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)', 'timeFrame': '30 Days post-vaccination', 'description': 'The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.'}, {'measure': 'Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.'}, {'measure': 'Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.'}, {'measure': 'Geometric Mean Fold Rise of Serotype-specific IgG', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.'}, {'measure': 'Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response', 'timeFrame': 'Day 1 (Baseline) and 30 days post-vaccination', 'description': 'Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia, Pneumococcal']}, 'referencesModule': {'references': [{'pmid': '39082735', 'type': 'RESULT', 'citation': 'Scott P, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26093&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.', 'detailedDescription': 'Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \\[23-valent\\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has received pneumococcal vaccine \\>= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).\n\nExclusion Criteria:\n\n* Has a history of invasive pneumococcal disease (IPD).\n* Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.\n* Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.\n* Has a coagulation disorder contraindicating intramuscular vaccination.\n* Has a known malignancy that is progressing or has required active treatment.\n* Has received PPSV23 followed by either PCV15 or PCV20.\n* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).\n* Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.\n* Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.\n* Has received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.\n* Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.'}, 'identificationModule': {'nctId': 'NCT05420961', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older', 'orgStudyIdInfo': {'id': 'V116-006'}, 'secondaryIdInfos': [{'id': 'jRCT2071220025', 'type': 'REGISTRY', 'domain': 'jRCT'}, {'id': '2021-006679-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: V116', 'description': 'Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1: PCV15', 'description': 'Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.', 'interventionNames': ['Biological: PCV15']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: V116', 'description': 'Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2: PPSV23', 'description': 'Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.', 'interventionNames': ['Biological: PPSV23']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: V116', 'description': 'Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.', 'interventionNames': ['Biological: V116']}], 'interventions': [{'name': 'V116', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 21-valent Conjugate Vaccine'], 'description': 'Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution', 'armGroupLabels': ['Cohort 1: V116', 'Cohort 2: V116', 'Cohort 3: V116']}, {'name': 'PCV15', 'type': 'BIOLOGICAL', 'otherNames': ['VAXNEUVANCE™'], 'description': 'Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension', 'armGroupLabels': ['Cohort 1: PCV15']}, {'name': 'PPSV23', 'type': 'BIOLOGICAL', 'otherNames': ['PNEUMOVAX™23'], 'description': 'Pneumococcal 23-valent vaccine with 25 μg of each of the PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution', 'armGroupLabels': ['Cohort 2: PPSV23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates ( Site 0024)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Lenzmeier Family Medicine/CCT Research ( Site 0008)', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Southland Clinical Research Center ( Site 0026)', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc. 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