Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-03-15 @ 12:11 PM
Study NCT ID:
NCT05425732
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'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'}]}}, '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': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.', 'description': 'ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.', 'otherNumAtRisk': 1177, 'deathsNumAtRisk': 1179, 'otherNumAffected': 615, 'seriousNumAtRisk': 1177, 'deathsNumAffected': 4, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Cohort 1: PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.', 'otherNumAtRisk': 1175, 'deathsNumAtRisk': 1179, 'otherNumAffected': 722, 'seriousNumAtRisk': 1175, 'deathsNumAffected': 2, 'seriousNumAffected': 24}, {'id': 'EG002', 'title': 'Cohort 2: V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 201, 'otherNumAffected': 161, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort 2: PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 78, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Unplanned Participants', 'description': 'Participants with unplanned randomization and unplanned treatment with both V116 and PCV20.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 243, 'numAffected': 240}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 237, 'numAffected': 235}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 81, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 83, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 87, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 474, 'numAffected': 471}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 615, 'numAffected': 608}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 143, 'numAffected': 143}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 74, 'numAffected': 74}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 79, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 105, 'numAffected': 103}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 75, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 83, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 176, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 184, 'numAffected': 174}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 62, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Jejunal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oral mucosa erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Subcapsular hepatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Encephalitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 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{'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 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{'groupId': 'EG002', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal 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': '1177', 'groupId': 'OG000'}, {'value': '1175', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 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'6.0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '14.0', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '-0.9', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '1.1', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Injection site erythema: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-16.2', 'ciUpperLimit': '-8.2', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Injection site pain: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 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'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}, {'value': '40.5', 'groupId': 'OG002'}, {'value': '34.0', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}, {'value': '29.5', 'groupId': 'OG002'}, {'value': '24.0', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}, {'value': '16.5', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '3.8', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Fatigue: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '1.2', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Headache: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '-0.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '1.2', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Myalgia: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.0', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Pyrexia: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '17.6', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Fatigue: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '05', 'paramValue': '5.5', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '15.5', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Headache: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '10.6', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Myalgia: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '6.2', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Pyrexia: estimated difference in percent', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Miettinen \\& Nurminen method'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine-related Serious AE (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1175', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 194 days post-vaccination', 'description': 'A vaccine-related SAE is any untoward medical consequence that 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 an other important medical event, which is determined by the investigator to be related to the vaccine.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.'}, {'type': 'PRIMARY', 'title': 'Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1154', 'groupId': 'OG000'}, {'value': '1161', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '274.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '176.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1148', 'groupId': 'OG000'}, {'value': '1153', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2302.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2972.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1152', 'groupId': 'OG000'}, {'value': '1158', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3637.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3429.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1155', 'groupId': 'OG000'}, {'value': '1158', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2501.3', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1811.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1161', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3893.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4678.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1145', 'groupId': 'OG000'}, {'value': '1150', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3232.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2092.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1160', 'groupId': 'OG000'}, {'value': '1161', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2641.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2499.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1159', 'groupId': 'OG000'}, {'value': '1162', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2136.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2817.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '1154', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3874.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4770.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1154', 'groupId': 'OG000'}, {'value': '1157', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13558.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11742.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'OG000'}, {'value': '1150', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7470.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1640.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1107', 'groupId': 'OG000'}, {'value': '1102', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5237.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1589.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '1158', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4216.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2072.3', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1151', 'groupId': 'OG000'}, {'value': '1153', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4868.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '846.3', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined..', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1148', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7764.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '460.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1161', 'groupId': 'OG000'}, {'value': '1155', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6099.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '631.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1132', 'groupId': 'OG000'}, {'value': '1104', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3737.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '461.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1160', 'groupId': 'OG000'}, {'value': '1160', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1082.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '107.3', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2728.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '70.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '1154', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3132.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '144.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8527.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1383.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.40', 'ciUpperLimit': '1.72', 'pValueComment': '1-sided', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 3: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.88', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 6A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.18', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 7F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '1.25', 'ciUpperLimit': '1.53', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 8: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.93', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 10A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.39', 'ciUpperLimit': '1.72', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 11A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.21', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 12F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.84', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 19A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.92', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 22F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.32', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 33F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.55', 'ciLowerLimit': '4.12', 'ciUpperLimit': '5.04', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 9N: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '2.91', 'ciUpperLimit': '3.74', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 15A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.03', 'ciLowerLimit': '1.77', 'ciUpperLimit': '2.34', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 15C: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.75', 'ciLowerLimit': '5.16', 'ciUpperLimit': '6.41', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 16F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.86', 'ciLowerLimit': '14.90', 'ciUpperLimit': '19.09', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 17F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.66', 'ciLowerLimit': '8.66', 'ciUpperLimit': '10.79', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 20A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.10', 'ciLowerLimit': '6.86', 'ciUpperLimit': '9.55', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 23A: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.09', 'ciLowerLimit': '8.48', 'ciUpperLimit': '12.00', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 23B: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.71', 'ciLowerLimit': '33.87', 'ciUpperLimit': '44.25', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 24F: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.69', 'ciLowerLimit': '18.68', 'ciUpperLimit': '25.18', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 31: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.17', 'ciLowerLimit': '5.59', 'ciUpperLimit': '6.80', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 35B: V116/PCV20 GMT Ratio', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \\> 2.0 (one-sided p-value \\< 0.025).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '19.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '937', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '74.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '20.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '952', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}, {'value': '1011', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.3', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '36.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1021', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '49.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '925', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.3', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '17.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '917', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.7', 'ciLowerLimit': '40.7', 'ciUpperLimit': '48.6', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 9N: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.9', 'ciLowerLimit': '25.8', 'ciUpperLimit': '35.8', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 15A: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '5.6', 'ciUpperLimit': '12.9', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 15C: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.1', 'ciLowerLimit': '47.1', 'ciUpperLimit': '54.9', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 16F: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.3', 'ciLowerLimit': '62.8', 'ciUpperLimit': '69.6', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 17F: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.7', 'ciLowerLimit': '54.2', 'ciUpperLimit': '61.1', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 20A: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.2', 'ciLowerLimit': '37.6', 'ciUpperLimit': '46.6', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 23A: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.9', 'ciLowerLimit': '32.1', 'ciUpperLimit': '39.6', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 23B: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.2', 'ciLowerLimit': '71.1', 'ciUpperLimit': '77.1', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype24F: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.6', 'ciLowerLimit': '54.8', 'ciUpperLimit': '62.1', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype 31: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.2', 'ciLowerLimit': '49.6', 'ciUpperLimit': '56.6', 'pValueComment': '1-sided', 'estimateComment': 'V116 minus PCV20', 'groupDescription': 'Serotype35B: V116-PCV20 Percentage Difference', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority is based on the lower bound of the 95% CI for the difference \\[V116 - PCV20\\] between the percentages of participants with a ≥4-fold rise from baseline being \\>10 percentage points (one-sided p-value \\< 0.025).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 18 to 49 Years Old', 'description': 'Pneumococcal vaccine-naïve adult participants 18 to 49 years of age receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'V116 50 to 64 Years Old', 'description': 'Pneumococcal vaccine-naïve adult participants 50 to 64 years of age receive a single dose of V116 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '308.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '282.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5289.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2572.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6447.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4278.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4516.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3004.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17283.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8791.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6808.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4382.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '564', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5871.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3785.8', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '574', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6150.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3561.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '550', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11319.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5901.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10194.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5708.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8877.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5720.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16070.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10068.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '574', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2773.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2374.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13150.0', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7562.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9299.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4683.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8848.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4739.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2140.1', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1420.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4137.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3047.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8005.6', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3820.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34805.5', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '17607.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13933.4', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9053.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.33', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.06', 'ciLowerLimit': '1.61', 'ciUpperLimit': '2.62', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '05', 'paramValue': '1.51', 'ciLowerLimit': '1.23', 'ciUpperLimit': '1.84', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.79', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.59', 'ciUpperLimit': '2.43', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.92', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.91', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '1.37', 'ciUpperLimit': '2.17', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.55', 'ciUpperLimit': '2.37', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.36', 'ciUpperLimit': '2.35', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.91', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '1.26', 'ciUpperLimit': '2.02', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.40', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.18', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '1.58', 'ciUpperLimit': '2.49', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '1.43', 'ciUpperLimit': '2.44', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.04', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.67', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.10', 'ciLowerLimit': '1.63', 'ciUpperLimit': '2.69', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '1.52', 'ciUpperLimit': '2.57', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.87', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '52.6'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '883', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '67.8'}]}]}], 'analyses': [{'pValue': '0.667', 'groupIds': ['OG000'], 'pValueComment': '1-sided', 'groupDescription': 'Serotype 6C', 'statisticalMethod': 'Clopper-Pearson method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a\n\n≥4-fold rise from baseline to 30 days postvaccination being \\> 50 percentage points (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': '1-sided', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 'Clopper-Pearson method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a\n\n≥4-fold rise from baseline to 30 days postvaccination being \\> 50 percentage points (one-sided p-value \\< 0.025).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being \\> 50 percentage points (one-sided p-value \\< 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 and V116 Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 18 to 49 Years Old', 'description': 'Pneumococcal vaccine-naïve adult participants in Cohort 2 (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'V116 50 to 64 Years Old', 'description': 'Pneumococcal vaccine-naïve adult participants n Cohort 1 50 to 64 years of age receive a single dose of V116 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': '6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2577.2', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1254.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10976.7', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5438.9', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.52', 'ciUpperLimit': '2.77', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.02', 'ciLowerLimit': '1.57', 'ciUpperLimit': '2.60', 'pValueComment': '1-sided', 'estimateComment': 'V116 18-49 years/V116 50-64 years', 'groupDescription': 'Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratio', 'statisticalMethod': 'LDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \\> 0.5 (one-sided p-value \\< 0.025).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.78', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.53', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.30', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.45', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.97', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.57', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.02', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.00', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.98', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.66', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.20', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.87', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.73', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.57', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.39', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.02', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.39', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.48', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.81', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.02', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined..', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.72', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.43', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.88', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.04', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.39', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.04', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.86', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.33', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.16', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.84', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.03', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.47', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.78', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.59', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.13', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.58', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.87', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.33', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.07', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.27', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1166', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.98', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.41', 'comment': 'NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.35', 'ciUpperLimit': '1.60', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 3: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.89', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 6A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.18', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 7F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.29', 'ciUpperLimit': '1.59', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 8: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.92', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 10A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.36', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 11A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.26', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 12F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.77', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 19A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.90', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 22F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.18', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 33F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.41', 'ciLowerLimit': '4.82', 'ciUpperLimit': '6.06', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 9N: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.79', 'ciLowerLimit': '6.03', 'ciUpperLimit': '7.64', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 15A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.46', 'ciLowerLimit': '2.17', 'ciUpperLimit': '2.79', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 15C: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.75', 'ciLowerLimit': '7.95', 'ciUpperLimit': '9.64', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 16F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.75', 'ciLowerLimit': '15.25', 'ciUpperLimit': '18.41', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 17F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '05', 'paramValue': '12.92', 'ciLowerLimit': '11.81', 'ciUpperLimit': '14.13', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 20A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.42', 'ciLowerLimit': '5.69', 'ciUpperLimit': '7.24', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 23A: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.25', 'ciLowerLimit': '2.91', 'ciUpperLimit': '3.64', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 23B: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '85', 'paramValue': '21.08', 'ciLowerLimit': '18.97', 'ciUpperLimit': '23.43', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 24F: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.31', 'ciLowerLimit': '10.36', 'ciUpperLimit': '12.34', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 31: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.13', 'ciLowerLimit': '12.97', 'ciUpperLimit': '15.40', 'estimateComment': 'V116/PCV20', 'groupDescription': 'Serotype 35B: V116/PCV20 GMC Ratio', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'cLDA model'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '966', 'groupId': 'OG000'}, {'value': '937', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '9.1'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.8'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '954', 'groupId': 'OG000'}, {'value': '931', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '20.2'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '25.5'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '967', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '18.8'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '16.8'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '999', 'groupId': 'OG000'}, {'value': '971', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '25.0'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '16.2'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}, 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{'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '938', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '11.1'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.5'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '9.9'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.2'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}, 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'lowerLimit': '8.7', 'upperLimit': '10.4'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.0'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '952', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '19.7'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}, {'value': '1011', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '11.4'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.2'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '25.0'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '3.6'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1021', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '58.2'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '925', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '32.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '24.9', 'upperLimit': '33.1'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.7'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '917', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '7.9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'GMFR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1101', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '5.4'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.7'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '13.5'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '16.6'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '13.7'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '13.4'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1102', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '13.8'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '9.6'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1099', 'groupId': 'OG000'}, {'value': '1070', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '16.9'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '21.1'}]}]}, {'title': 'Serotype11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1095', 'groupId': 'OG000'}, {'value': '1071', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '9.5'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '7.7'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1100', 'groupId': 'OG000'}, {'value': '1073', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 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{'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '10.5'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '9.9'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1098', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '16.5'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '2.9'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}, {'value': '1061', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '24.4'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '3.7'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1095', 'groupId': 'OG000'}, {'value': '1071', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '21.8'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '9.0'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '14.4'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '1.7'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1098', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '21.7'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1077', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '12.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.0'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1091', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '19.5'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '3.1'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '13.3'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '4.1'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1093', 'groupId': 'OG000'}, {'value': '1077', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '23.4'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '14.0'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '16.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'GMFR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1101', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '53.5', 'upperLimit': '59.4'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '38.0', 'upperLimit': '44.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '75.7'}, {'value': '79.7', 'groupId': 'OG001', 'lowerLimit': '77.2', 'upperLimit': '82.1'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '78.9'}, {'value': '75.8', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '78.4'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1102', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '73.1', 'upperLimit': '78.3'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '64.9', 'upperLimit': '70.6'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1099', 'groupId': 'OG000'}, {'value': '1070', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '82.6'}, {'value': '82.0', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '84.2'}]}]}, {'title': 'Serotype11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1095', 'groupId': 'OG000'}, {'value': '1071', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '68.4', 'upperLimit': '73.8'}, {'value': '62.7', 'groupId': 'OG001', 'lowerLimit': '59.8', 'upperLimit': '65.6'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1100', 'groupId': 'OG000'}, {'value': '1073', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '76.7'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '68.6', 'upperLimit': '74.1'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1098', 'groupId': 'OG000'}, {'value': '1070', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '52.6', 'upperLimit': '58.5'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '62.0', 'upperLimit': '67.8'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1099', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '79.3'}, {'value': '78.5', 'groupId': 'OG001', 'lowerLimit': '76.0', 'upperLimit': '81.0'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '74.2'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '63.8', 'upperLimit': '69.6'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1098', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '80.3'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '32.2'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}, {'value': '1061', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '87.8'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '40.7'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1095', 'groupId': 'OG000'}, {'value': '1071', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '78.9', 'upperLimit': '83.6'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '60.2', 'upperLimit': '66.1'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '78.9', 'upperLimit': '83.6'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '13.9'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1098', 'groupId': 'OG000'}, {'value': '1076', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '86.6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '5.7'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1097', 'groupId': 'OG000'}, {'value': '1077', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '72.1', 'upperLimit': '77.3'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.2'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1091', 'groupId': 'OG000'}, {'value': '1074', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '87.6'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '32.2'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '73.4', 'upperLimit': '78.6'}, {'value': '42.2', 'groupId': 'OG001', 'lowerLimit': '39.3', 'upperLimit': '45.2'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1093', 'groupId': 'OG000'}, {'value': '1077', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '86.1'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.4'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '83.4'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '5.2'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000', 'lowerLimit': '80.8', 'upperLimit': '85.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '4.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'OG000'}, {'value': '1177', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '966', 'groupId': 'OG000'}, {'value': '937', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '68.4', 'upperLimit': '74.2'}, {'value': '59.1', 'groupId': 'OG001', 'lowerLimit': '55.9', 'upperLimit': '62.3'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '954', 'groupId': 'OG000'}, {'value': '931', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '79.5'}, {'value': '79.9', 'groupId': 'OG001', 'lowerLimit': '77.2', 'upperLimit': '82.4'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '967', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '73.9'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '62.8', 'upperLimit': '68.9'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '999', 'groupId': 'OG000'}, {'value': '971', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '78.4'}, {'value': '67.4', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '70.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '69.0', 'upperLimit': '74.6'}, {'value': '74.1', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '76.9'}]}]}, {'title': 'Serotype11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '890', 'groupId': 'OG000'}, {'value': '889', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '73.0'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': '64.7'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1031', 'groupId': 'OG000'}, {'value': '1022', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '90.9'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '84.9', 'upperLimit': '89.1'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1024', 'groupId': 'OG000'}, {'value': '990', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '67.3'}, {'value': '70.2', 'groupId': 'OG001', 'lowerLimit': '67.2', 'upperLimit': '73.0'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '936', 'groupId': 'OG000'}, {'value': '935', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '73.4'}, {'value': '74.4', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '77.2'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '938', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '70.7'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '58.3', 'upperLimit': '64.6'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '67.8'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '22.6'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '63.0', 'upperLimit': '70.2'}, {'value': '35.8', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '39.5'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '937', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '80.9', 'upperLimit': '85.7'}, {'value': '74.2', 'groupId': 'OG001', 'lowerLimit': '71.2', 'upperLimit': '76.9'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}, {'value': '961', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '74.8'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '23.5'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '952', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '78.6'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '11.5'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1003', 'groupId': 'OG000'}, {'value': '1011', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '70.2'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '11.6'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}, {'value': '734', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '81.7'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '33.3', 'upperLimit': '40.4'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1021', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '87.6'}, {'value': '49.6', 'groupId': 'OG001', 'lowerLimit': '46.4', 'upperLimit': '52.7'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '925', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '83.0'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 'groupId': 'OG000'}, {'value': '954', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '73.6', 'upperLimit': '79.3'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '20.5'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '917', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '63.2'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '8.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.'}, {'id': 'FG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.'}, {'id': 'FG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'FG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized participants', 'achievements': [{'comment': 'Includes two participants with unplanned randomization to both PCV20 and V116', 'groupId': 'FG000', 'numSubjects': '1181'}, {'comment': 'Includes two participants with unplanned randomization to both PCV20 and V116', 'groupId': 'FG001', 'numSubjects': '1181'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'Vaccinated', 'comment': 'Randomized participants who were vaccinated', 'achievements': [{'comment': 'Includes two participants with unplanned vaccination with both PCV20 and V116', 'groupId': 'FG000', 'numSubjects': '1179'}, {'comment': 'Includes two participants with unplanned vaccination with both PCV20 and V116', 'groupId': 'FG001', 'numSubjects': '1177'}, {'groupId': 'FG002', 'numSubjects': '200'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'Safety All Cause Mortality (ACM) Population', 'achievements': [{'comment': '.The two participants with unplanned randomization and vaccination with both V116 and PCV20 are excluded from the ACM population', 'groupId': 'FG000', 'numSubjects': '1179'}, {'comment': 'The two participants with unplanned randomization and vaccination with both V116 and PCV20 are excluded from the ACM population', 'groupId': 'FG001', 'numSubjects': '1179'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'All Participants As Treated (APaT)', 'comment': 'Randomized participants who were included in the group corresponding to the vaccine they actually received', 'achievements': [{'comment': 'The two participants with unplanned randomization to both the V116 and PCV20 treatment groups were excluded from the All Participants As Treated population.', 'groupId': 'FG000', 'numSubjects': '1177'}, {'comment': 'The two participants with unplanned randomization to both the V116 and PCV20 treatment groups were excluded from the All Participant As Treated population.', 'groupId': 'FG001', 'numSubjects': '1175'}, {'groupId': 'FG002', 'numSubjects': '200'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'Safety Adverse Event (AE) Population', 'comment': 'All Participants As Treated (APaT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1177'}, {'groupId': 'FG001', 'numSubjects': '1175'}, {'groupId': 'FG002', 'numSubjects': '200'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1160'}, {'groupId': 'FG001', 'numSubjects': '1152'}, {'groupId': 'FG002', 'numSubjects': '195'}, {'groupId': 'FG003', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized By Mistake Without Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Randomized to PCV20 first, discontinued; then randomized to V116 second', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Pneumococcal vaccine-naïve adults ≥18 years of age were enrolled in this study. Participants with underlying chronic conditions were eligible if the conditions were assessed to be stable per the investigator's judgment."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1179', 'groupId': 'BG000'}, {'value': '1177', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '2656', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'BG001', 'title': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'BG002', 'title': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.'}, {'id': 'BG003', 'title': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '34.6', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '60.7', 'spread': '12.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 to 49 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}]}, {'title': '50 to 64 years', 'categories': [{'measurements': [{'value': '589', 'groupId': 'BG000'}, {'value': '587', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1176', 'groupId': 'BG004'}]}]}, {'title': '65 to 74 years', 'categories': [{'measurements': [{'value': '464', 'groupId': 'BG000'}, {'value': '464', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '928', 'groupId': 'BG004'}]}]}, {'title': '75 to 84 years', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}]}, {'title': '≥85 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '687', 'groupId': 'BG000'}, {'value': '670', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '1558', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '492', 'groupId': 'BG000'}, {'value': '507', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '1098', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '583', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '909', 'groupId': 'BG000'}, {'value': '922', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '2048', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '369', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '258', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '867', 'groupId': 'BG000'}, {'value': '844', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '1912', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All vaccinated participants. Includes two participants from Cohort 1 who had unplanned vaccinations with both V116 and PCV20'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-16', 'size': 2811998, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-10T14:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2663}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2022-06-15', 'resultsFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-10', 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs)', 'timeFrame': 'Up to 5 days post-vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, 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 clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C)'}, {'measure': 'Percentage of Participants With Vaccine-related Serious AE (SAE)', 'timeFrame': 'Up to 194 days post-vaccination', 'description': 'A vaccine-related SAE is any untoward medical consequence that 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 an other important medical event, which is determined by the investigator to be related to the vaccine.'}, {'measure': 'Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being \\> 50 percentage points (one-sided p-value \\< 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.'}, {'measure': 'Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20', 'timeFrame': 'Day 30 post-vaccination', 'description': 'The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}, {'measure': 'Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20', 'timeFrame': 'Baseline and Day 30 post-vaccination', 'description': 'Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infection']}, 'referencesModule': {'references': [{'pmid': '38964361', 'type': 'RESULT', 'citation': 'Platt HL, Bruno C, Buntinx E, Pelayo E, Garcia-Huidobro D, Barranco-Santana EA, Sjoberg F, Song JY, Grijalva CG, Orenstein WA, Morgan L, Fernsler D, Xu W, Waleed M, Li J, Buchwald UK; STRIDE-3 Study Group. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial. Lancet Infect Dis. 2024 Oct;24(10):1141-1150. doi: 10.1016/S1473-3099(24)00344-X. Epub 2024 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26092&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\\[Prevnar 20™ / APEXXNAR™\\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.\n\nExclusion Criteria:\n\n* Has a history of invasive pneumococcal disease (IPD) \\[positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site\\] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)\n* Has a known hypersensitivity to any component of V116 or PCV20, 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 IM vaccination\n* Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \\[≥38.0°C\\] or axillary or temporal temperature ≥99.4°F \\[≥37.4°C\\]) or received antibiotic therapy for any acute illness occurring \\<72 hours before receipt of study vaccine\n* Has a known malignancy that is progressing or has required active treatment \\<3 years before enrollment\n* Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol\n* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine\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* Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)\n* 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* 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 postvaccination blood draw is complete'}, 'identificationModule': {'nctId': 'NCT05425732', 'briefTitle': 'Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults', 'orgStudyIdInfo': {'id': 'V116-003'}, 'secondaryIdInfos': [{'id': 'V116-003', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2022-000258-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.', 'interventionNames': ['Biological: PCV20']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 V116', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2 PCV20', 'description': 'Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.', 'interventionNames': ['Biological: PCV20']}], 'interventions': [{'name': 'V116', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 21-valent Conjugate Vaccine'], 'description': '0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.', 'armGroupLabels': ['Cohort 1 V116', 'Cohort 2 V116']}, {'name': 'PCV20', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar 20™', 'APEXXNAR™'], 'description': '0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.', 'armGroupLabels': ['Cohort 1 PCV20', 'Cohort 2 PCV20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates ( Site 0067)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Lenzmeier Family Medicine/CCT Research ( Site 0006)', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Clinical Research/ CCT Research ( Site 0040)', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85044', 'city': 'Phoenix', 'state': 'Arizona', 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