Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-02 @ 12:14 PM
Study NCT ID:
NCT05633992
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 30 days', 'description': 'All participants who received at least 1 dose of study intervention are included.', 'eventGroups': [{'id': 'EG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 77, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 96, 'seriousNumAtRisk': 225, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 60, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 82, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'seriousEvents': [{'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days postvaccination', '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. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all participants who received ≥1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days postvaccination', '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. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all participants who received ≥1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine-related Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days postvaccination', 'description': 'An SAE is any untoward medical occurrence 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 another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all participants who received ≥1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Day 30, Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.1', 'groupId': 'OG000', 'lowerLimit': '133.6', 'upperLimit': '180.1'}, {'value': '170.8', 'groupId': 'OG001', 'lowerLimit': '143.9', 'upperLimit': '202.9'}]}]}, {'title': 'Day 30, Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2675.1', 'groupId': 'OG000', 'lowerLimit': '2312.9', 'upperLimit': '3094.0'}, {'value': '2411.4', 'groupId': 'OG001', 'lowerLimit': '2054.5', 'upperLimit': '2830.2'}]}]}, {'title': 'Day 30, Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1293.3', 'groupId': 'OG000', 'lowerLimit': '1133.8', 'upperLimit': '1475.2'}, {'value': '1142.4', 'groupId': 'OG001', 'lowerLimit': '988.3', 'upperLimit': '1320.4'}]}]}, {'title': 'Day 30, Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2844.8', 'groupId': 'OG000', 'lowerLimit': '2492.7', 'upperLimit': '3246.6'}, {'value': '2710.5', 'groupId': 'OG001', 'lowerLimit': '2297.6', 'upperLimit': '3197.6'}]}]}, {'title': 'Day 30, Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1591.2', 'groupId': 'OG000', 'lowerLimit': '1367.4', 'upperLimit': '1851.7'}, {'value': '880.2', 'groupId': 'OG001', 'lowerLimit': '690.1', 'upperLimit': '1122.6'}]}]}, {'title': 'Day 30, Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1269.6', 'groupId': 'OG000', 'lowerLimit': '1057.6', 'upperLimit': '1524.1'}, {'value': '887.9', 'groupId': 'OG001', 'lowerLimit': '748.3', 'upperLimit': '1053.4'}]}]}, {'title': 'Day 30, Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '968.5', 'groupId': 'OG000', 'lowerLimit': '792.5', 'upperLimit': '1183.6'}, {'value': '503.7', 'groupId': 'OG001', 'lowerLimit': '383.8', 'upperLimit': '661.0'}]}]}, {'title': 'Day 30, Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3138.1', 'groupId': 'OG000', 'lowerLimit': '2673.0', 'upperLimit': '3684.2'}, {'value': '1860.3', 'groupId': 'OG001', 'lowerLimit': '1551.8', 'upperLimit': '2230.1'}]}]}, {'title': 'Day 30, Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1338.4', 'groupId': 'OG000', 'lowerLimit': '1144.3', 'upperLimit': '1565.4'}, {'value': '1140.7', 'groupId': 'OG001', 'lowerLimit': '925.1', 'upperLimit': '1406.5'}]}]}, {'title': 'Day 30, Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2617.2', 'groupId': 'OG000', 'lowerLimit': '2212.9', 'upperLimit': '3095.5'}, {'value': '1731.5', 'groupId': 'OG001', 'lowerLimit': '1474.1', 'upperLimit': '2033.7'}]}]}, {'title': 'Day 30, Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1830.9', 'groupId': 'OG000', 'lowerLimit': '1562.4', 'upperLimit': '2145.6'}, {'value': '1295.5', 'groupId': 'OG001', 'lowerLimit': '1072.6', 'upperLimit': '1564.8'}]}]}, {'title': 'Day 30, Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7692.4', 'groupId': 'OG000', 'lowerLimit': '6349.4', 'upperLimit': '9319.4'}, {'value': '8610.8', 'groupId': 'OG001', 'lowerLimit': '7029.9', 'upperLimit': '10547.1'}]}]}, {'title': 'Day 30, Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2488.5', 'groupId': 'OG000', 'lowerLimit': '1993.5', 'upperLimit': '3106.6'}, {'value': '1185.0', 'groupId': 'OG001', 'lowerLimit': '954.1', 'upperLimit': '1471.7'}]}]}, {'title': 'Day 30, Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2081.1', 'groupId': 'OG000', 'lowerLimit': '1675.0', 'upperLimit': '2585.7'}, {'value': '1479.7', 'groupId': 'OG001', 'lowerLimit': '1218.0', 'upperLimit': '1797.5'}]}]}, {'title': 'Baseline, Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '16.1'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '17.0'}]}]}, {'title': 'Baseline, Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243.9', 'groupId': 'OG000', 'lowerLimit': '190.8', 'upperLimit': '311.7'}, {'value': '217.6', 'groupId': 'OG001', 'lowerLimit': '168.8', 'upperLimit': '280.4'}]}]}, {'title': 'Baseline, Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '38.3', 'upperLimit': '62.3'}, {'value': '46.3', 'groupId': 'OG001', 'lowerLimit': '36.7', 'upperLimit': '58.5'}]}]}, {'title': 'Baseline, Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '383.1', 'groupId': 'OG000', 'lowerLimit': '313.3', 'upperLimit': '468.4'}, {'value': '383.2', 'groupId': 'OG001', 'lowerLimit': '314.6', 'upperLimit': '466.8'}]}]}, {'title': 'Baseline, Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.5', 'groupId': 'OG000', 'lowerLimit': '101.3', 'upperLimit': '170.6'}, {'value': '103.5', 'groupId': 'OG001', 'lowerLimit': '77.4', 'upperLimit': '138.5'}]}]}, {'title': 'Baseline, Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '101.3'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '68.3', 'upperLimit': '121.7'}]}]}, {'title': 'Baseline, Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '22.3'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '23.7'}]}]}, {'title': 'Baseline, Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '285.8', 'groupId': 'OG000', 'lowerLimit': '225.7', 'upperLimit': '361.8'}, {'value': '226.8', 'groupId': 'OG001', 'lowerLimit': '181.0', 'upperLimit': '284.1'}]}]}, {'title': 'Baseline, Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '188.1', 'groupId': 'OG000', 'lowerLimit': '151.9', 'upperLimit': '232.8'}, {'value': '179.7', 'groupId': 'OG001', 'lowerLimit': '143.4', 'upperLimit': '225.1'}]}]}, {'title': 'Baseline, Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '460.0', 'groupId': 'OG000', 'lowerLimit': '384.4', 'upperLimit': '550.6'}, {'value': '421.1', 'groupId': 'OG001', 'lowerLimit': '348.9', 'upperLimit': '508.1'}]}]}, {'title': 'Baseline, Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '179.9', 'groupId': 'OG000', 'lowerLimit': '138.0', 'upperLimit': '234.7'}, {'value': '167.9', 'groupId': 'OG001', 'lowerLimit': '128.0', 'upperLimit': '220.3'}]}]}, {'title': 'Baseline, Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1236.7', 'groupId': 'OG000', 'lowerLimit': '1048.1', 'upperLimit': '1459.3'}, {'value': '1198.9', 'groupId': 'OG001', 'lowerLimit': '1004.3', 'upperLimit': '1431.3'}]}]}, {'title': 'Baseline, Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.0', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '142.1'}, {'value': '102.6', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '132.4'}]}]}, {'title': 'Baseline, Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243.3', 'groupId': 'OG000', 'lowerLimit': '194.6', 'upperLimit': '304.1'}, {'value': '251.7', 'groupId': 'OG001', 'lowerLimit': '199.7', 'upperLimit': '317.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.17', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 3', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.33', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 7F', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.36', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 8', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.29', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 9N', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.14', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 10A', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.92', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 11A', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.43', 'ciUpperLimit': '2.72', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 12F', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.00', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 17F', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.45', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 19A', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.77', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 20A', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.76', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 22F', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.12', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 33F', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.89', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 15B', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>0.5 (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Day 30 GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.56', 'ciUpperLimit': '2.70', 'estimateComment': 'Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.', 'groupDescription': 'Serotype 15C', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum', 'nonInferiorityComment': 'For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \\>1.0 (one-sided p-value \\<0.025).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000'}, {'value': '45.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000'}, {'value': '43.7', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.6', 'ciLowerLimit': '17.8', 'ciUpperLimit': '36.9', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 6A', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.7', 'ciLowerLimit': '23.6', 'ciUpperLimit': '43.0', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 15A', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.3', 'ciLowerLimit': '29.8', 'ciUpperLimit': '46.4', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 16F', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.5', 'ciLowerLimit': '17.4', 'ciUpperLimit': '40.6', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 23A', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.3', 'ciLowerLimit': '29.3', 'ciUpperLimit': '46.7', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 23B', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.1', 'ciLowerLimit': '18.3', 'ciUpperLimit': '35.6', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 24F', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.3', 'ciLowerLimit': '49.3', 'ciUpperLimit': '64.4', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 31', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.0', 'ciLowerLimit': '39.5', 'ciUpperLimit': '54.1', 'estimateComment': 'Estimated difference and confidence interval are based on the Miettinen \\& Nurminen method.', 'groupDescription': 'Serotype 35B', 'statisticalMethod': 'Stratified Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \\>0 percentage points (one-sided p-value \\<0.025).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points."}, {'type': 'SECONDARY', 'title': 'Serotype-specific OPA GMTs (Unique Serotypes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1263.8', 'groupId': 'OG000', 'lowerLimit': '1036.6', 'upperLimit': '1540.7'}, {'value': '641.8', 'groupId': 'OG001', 'lowerLimit': '507.0', 'upperLimit': '812.4'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2752.3', 'groupId': 'OG000', 'lowerLimit': '2319.8', 'upperLimit': '3265.5'}, {'value': '832.2', 'groupId': 'OG001', 'lowerLimit': '687.4', 'upperLimit': '1007.6'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4094.8', 'groupId': 'OG000', 'lowerLimit': '3574.8', 'upperLimit': '4690.4'}, {'value': '1183.9', 'groupId': 'OG001', 'lowerLimit': '987.2', 'upperLimit': '1419.7'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2107.5', 'groupId': 'OG000', 'lowerLimit': '1702.3', 'upperLimit': '2609.1'}, {'value': '729.2', 'groupId': 'OG001', 'lowerLimit': '556.8', 'upperLimit': '955.0'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1359.0', 'groupId': 'OG000', 'lowerLimit': '1086.7', 'upperLimit': '1699.5'}, {'value': '202.2', 'groupId': 'OG001', 'lowerLimit': '146.5', 'upperLimit': '279.2'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2521.9', 'groupId': 'OG000', 'lowerLimit': '2246.2', 'upperLimit': '2831.4'}, {'value': '1043.8', 'groupId': 'OG001', 'lowerLimit': '878.1', 'upperLimit': '1240.7'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2095.4', 'groupId': 'OG000', 'lowerLimit': '1746.3', 'upperLimit': '2514.2'}, {'value': '260.7', 'groupId': 'OG001', 'lowerLimit': '200.9', 'upperLimit': '338.2'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4758.1', 'groupId': 'OG000', 'lowerLimit': '4146.5', 'upperLimit': '5459.9'}, {'value': '1051.4', 'groupId': 'OG001', 'lowerLimit': '886.6', 'upperLimit': '1246.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available."}, {'type': 'SECONDARY', 'title': 'Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.61'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '0.67'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.12', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '7.31'}, {'value': '4.25', 'groupId': 'OG001', 'lowerLimit': '3.50', 'upperLimit': '5.14'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.13', 'groupId': 'OG000', 'lowerLimit': '7.01', 'upperLimit': '9.42'}, {'value': '6.72', 'groupId': 'OG001', 'lowerLimit': '5.87', 'upperLimit': '7.71'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.49', 'groupId': 'OG000', 'lowerLimit': '6.23', 'upperLimit': '9.01'}, {'value': '5.44', 'groupId': 'OG001', 'lowerLimit': '4.55', 'upperLimit': '6.50'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.21', 'groupId': 'OG000', 'lowerLimit': '6.64', 'upperLimit': '10.15'}, {'value': '3.84', 'groupId': 'OG001', 'lowerLimit': '3.09', 'upperLimit': '4.79'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '5.09', 'upperLimit': '7.08'}, {'value': '3.02', 'groupId': 'OG001', 'lowerLimit': '2.59', 'upperLimit': '3.52'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.95'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.84'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.48', 'groupId': 'OG000', 'lowerLimit': '8.77', 'upperLimit': '12.52'}, {'value': '5.08', 'groupId': 'OG001', 'lowerLimit': '4.32', 'upperLimit': '5.98'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.70', 'groupId': 'OG000', 'lowerLimit': '4.80', 'upperLimit': '6.76'}, {'value': '4.87', 'groupId': 'OG001', 'lowerLimit': '4.07', 'upperLimit': '5.83'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.61', 'groupId': 'OG000', 'lowerLimit': '13.20', 'upperLimit': '18.47'}, {'value': '9.78', 'groupId': 'OG001', 'lowerLimit': '8.09', 'upperLimit': '11.83'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000', 'lowerLimit': '2.28', 'upperLimit': '3.52'}, {'value': '1.39', 'groupId': 'OG001', 'lowerLimit': '1.14', 'upperLimit': '1.69'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.93', 'groupId': 'OG000', 'lowerLimit': '11.92', 'upperLimit': '16.27'}, {'value': '12.67', 'groupId': 'OG001', 'lowerLimit': '10.90', 'upperLimit': '14.74'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.42', 'groupId': 'OG000', 'lowerLimit': '2.74', 'upperLimit': '4.26'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '1.33', 'upperLimit': '2.02'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.98', 'groupId': 'OG000', 'lowerLimit': '8.14', 'upperLimit': '12.25'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '1.98'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.87', 'groupId': 'OG000', 'lowerLimit': '7.95', 'upperLimit': '12.26'}, {'value': '4.55', 'groupId': 'OG001', 'lowerLimit': '3.69', 'upperLimit': '5.60'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '3.68'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.43'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '2.51'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.39'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.22', 'groupId': 'OG000', 'lowerLimit': '3.58', 'upperLimit': '4.99'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '1.37', 'upperLimit': '1.98'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.79', 'groupId': 'OG000', 'lowerLimit': '6.26', 'upperLimit': '9.71'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.35', 'upperLimit': '0.47'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000', 'lowerLimit': '2.16', 'upperLimit': '3.07'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.34', 'upperLimit': '0.46'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.19', 'groupId': 'OG000', 'lowerLimit': '12.01', 'upperLimit': '16.76'}, {'value': '1.38', 'groupId': 'OG001', 'lowerLimit': '1.19', 'upperLimit': '1.60'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.46'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.59'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.15', 'groupId': 'OG000', 'lowerLimit': '8.35', 'upperLimit': '12.35'}, {'value': '9.86', 'groupId': 'OG001', 'lowerLimit': '8.40', 'upperLimit': '11.59'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL).', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available."}, {'type': 'SECONDARY', 'title': 'Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '8.5'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '8.5'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '12.6'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '12.1'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '25.8'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '23.7'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '8.5'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '12.4'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '9.9'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '17.7'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '9.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '40.3'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '22.1'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '12.4'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '8.6'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '8.1'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '6.6'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '4.8'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '11.5'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '8.8'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '7.8'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '8.8'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '11.6'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.5'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '8.5'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.4'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '24.1'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '11.7'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.6'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.7'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.4'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '33.6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '5.4'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '4.6'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.8'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '17.3'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.6'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '6.5'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.7'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.3'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '9.5'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '6.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points."}, {'type': 'SECONDARY', 'title': 'Serotype-specific GMFR in IgG GMCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.7'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '5.8'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '14.3'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '9.7'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '13.7'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '11.3'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '14.3'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '11.5'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '13.4'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.4'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '9.4'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '4.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '14.6'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '7.5'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '15.2'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '5.9'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '4.9'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '11.2'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '7.2'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '12.9'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '6.6'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '10.2'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.9'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '12.5'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '4.7'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '16.5'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.1'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '17.3'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '14.9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '1.7'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '14.4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.2'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '10.0'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.5'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '21.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '10.5'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '1.6'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '14.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '3.2'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.4'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '8.2'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '8.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '79.9'}, {'value': '71.3', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '77.5'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000', 'lowerLimit': '61.9', 'upperLimit': '74.7'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '75.6'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '85.0'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '75.1', 'upperLimit': '86.1'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '65.0'}, {'value': '58.8', 'groupId': 'OG001', 'lowerLimit': '51.1', 'upperLimit': '66.1'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '75.6'}, {'value': '59.7', 'groupId': 'OG001', 'lowerLimit': '52.4', 'upperLimit': '66.7'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '75.6'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '62.9'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '78.7', 'upperLimit': '88.8'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '80.1'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '58.8', 'upperLimit': '72.9'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '55.3', 'upperLimit': '69.5'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000', 'lowerLimit': '51.2', 'upperLimit': '64.7'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '67.6'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000', 'lowerLimit': '47.1', 'upperLimit': '61.1'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '49.6'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '68.6'}, {'value': '52.3', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '59.4'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '51.1', 'upperLimit': '64.7'}, {'value': '63.7', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '70.2'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000', 'lowerLimit': '65.8', 'upperLimit': '79.1'}, {'value': '45.3', 'groupId': 'OG001', 'lowerLimit': '38.0', 'upperLimit': '52.6'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '66.9'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '33.3'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '74.9', 'upperLimit': '86.2'}, {'value': '65.4', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': '72.2'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000', 'lowerLimit': '43.1', 'upperLimit': '57.4'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '17.2'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '49.1', 'upperLimit': '65.8'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '37.2'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '87.1'}, {'value': '43.7', 'groupId': 'OG001', 'lowerLimit': '36.7', 'upperLimit': '50.9'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '50.1'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '22.3'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '76.3'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '18.4'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '59.7'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '10.0'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '41.1'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '32.1'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '73.9'}, {'value': '54.6', 'groupId': 'OG001', 'lowerLimit': '47.1', 'upperLimit': '61.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '63.0'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '52.8', 'upperLimit': '66.0'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '83.0'}, {'value': '70.7', 'groupId': 'OG001', 'lowerLimit': '64.2', 'upperLimit': '76.5'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '83.8'}, {'value': '78.7', 'groupId': 'OG001', 'lowerLimit': '72.7', 'upperLimit': '83.8'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '78.6'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '68.9', 'upperLimit': '80.6'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '84.2'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '55.1', 'upperLimit': '68.2'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000', 'lowerLimit': '62.9', 'upperLimit': '75.3'}, {'value': '44.9', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '51.6'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '79.0'}, {'value': '56.9', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '63.5'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '77.1', 'upperLimit': '87.4'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '62.9', 'upperLimit': '75.3'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '56.1'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '53.9'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '80.6'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '52.8', 'upperLimit': '66.0'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '65.2', 'upperLimit': '77.4'}, {'value': '56.9', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '63.5'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '65.2', 'upperLimit': '77.4'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '67.0', 'upperLimit': '79.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '81.8'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '52.5'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000', 'lowerLimit': '75.1', 'upperLimit': '85.8'}, {'value': '27.6', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '33.9'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '83.0'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '67.7'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '74.7', 'upperLimit': '85.4'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '12.4'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '70.8', 'upperLimit': '82.2'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '20.0'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '78.6'}, {'value': '35.6', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '42.2'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000', 'lowerLimit': '82.5', 'upperLimit': '91.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '81.0'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '11.8'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '78.5', 'upperLimit': '88.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.2'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '36.2'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '10.8'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '66.9'}, {'value': '65.3', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '71.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'FG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'BG001', 'title': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.9', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '70.9', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '70.9', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)', 'classes': [{'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '108.5', 'groupId': 'BG000', 'lowerLimit': '19.5', 'upperLimit': '3133'}, {'value': '149.1', 'groupId': 'BG001', 'lowerLimit': '19.5', 'upperLimit': '9061'}, {'value': '127.9', 'groupId': 'BG002', 'lowerLimit': '19.5', 'upperLimit': '9061'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '387.0', 'groupId': 'BG000', 'lowerLimit': '21.0', 'upperLimit': '9904'}, {'value': '416.4', 'groupId': 'BG001', 'lowerLimit': '21.0', 'upperLimit': '9477'}, {'value': '401.3', 'groupId': 'BG002', 'lowerLimit': '21.0', 'upperLimit': '9904'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '820.5', 'groupId': 'BG000', 'lowerLimit': '78.0', 'upperLimit': '25880'}, {'value': '757.9', 'groupId': 'BG001', 'lowerLimit': '78.0', 'upperLimit': '25880'}, {'value': '787.8', 'groupId': 'BG002', 'lowerLimit': '78.0', 'upperLimit': '175891'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '324.0', 'groupId': 'BG000', 'lowerLimit': '21.0', 'upperLimit': '14131'}, {'value': '344.8', 'groupId': 'BG001', 'lowerLimit': '21.0', 'upperLimit': '7126'}, {'value': '333.9', 'groupId': 'BG002', 'lowerLimit': '21.0', 'upperLimit': '14131'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'BG000', 'lowerLimit': '5.0', 'upperLimit': '4303'}, {'value': '41.2', 'groupId': 'BG001', 'lowerLimit': '5.0', 'upperLimit': '4834'}, {'value': '38.9', 'groupId': 'BG002', 'lowerLimit': '5.0', 'upperLimit': '4834'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '627.6', 'groupId': 'BG000', 'lowerLimit': '10.5', 'upperLimit': '10682'}, {'value': '641.9', 'groupId': 'BG001', 'lowerLimit': '10.5', 'upperLimit': '8032'}, {'value': '634.6', 'groupId': 'BG002', 'lowerLimit': '10.5', 'upperLimit': '10682'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '129.0', 'groupId': 'BG000', 'lowerLimit': '8.0', 'upperLimit': '3765'}, {'value': '176.5', 'groupId': 'BG001', 'lowerLimit': '8.0', 'upperLimit': '71474'}, {'value': '151.0', 'groupId': 'BG002', 'lowerLimit': '8.0', 'upperLimit': '71474'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '852.6', 'groupId': 'BG000', 'lowerLimit': '12.0', 'upperLimit': '12052'}, {'value': '937.0', 'groupId': 'BG001', 'lowerLimit': '12.0', 'upperLimit': '11378'}, {'value': '893.7', 'groupId': 'BG002', 'lowerLimit': '12.0', 'upperLimit': '12052'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'description': 'OPA GMT for each serotype in V116, estimated using a constrained longitudinal data analysis (cLDA) model.', 'unitOfMeasure': 'Titers', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'The analysis population consists of all randomized participants who had available baseline data.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-29', 'size': 612603, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-01T13:29', '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': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2022-11-21', 'resultsFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-01', 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs)', 'timeFrame': 'Up to 5 days postvaccination', '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. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs', 'timeFrame': 'Up to 5 days postvaccination', '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. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.'}, {'measure': 'Percentage of Participants With Vaccine-related Serious AEs (SAEs)', 'timeFrame': 'Up to 30 days postvaccination', 'description': 'An SAE is any untoward medical occurrence 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 another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.'}, {'measure': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).'}, {'measure': 'Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined.'}], 'secondaryOutcomes': [{'measure': 'Serotype-specific OPA GMTs (Unique Serotypes)', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA.'}, {'measure': 'Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)', 'timeFrame': 'Day 30 postvaccination', 'description': 'The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL).'}, {'measure': 'Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.'}, {'measure': 'Serotype-specific GMFR in IgG GMCs', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.'}, {'measure': 'Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'referencesModule': {'references': [{'pmid': '40763490', 'type': 'DERIVED', 'citation': 'Kishino H, Inoue S, Matsuoka O, Yagi M, Igarashi R, Oshima N, Sawata M, Platt HL. A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naive Japanese adults >/=65 years of age. Vaccine. 2025 Aug 30;62:127456. doi: 10.1016/j.vaccine.2025.127456. Epub 2025 Aug 5.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is Japanese\n* For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion 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 PPSV23, including diphtheria toxoid\n* Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease\n* Has a coagulation disorder contraindicating 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 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': 'NCT05633992', 'briefTitle': 'Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)', '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 Japanese Adults 65 Years of Age or Older', 'orgStudyIdInfo': {'id': 'V116-009'}, 'secondaryIdInfos': [{'id': 'jRCT2031220551', 'type': 'REGISTRY', 'domain': 'jRCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V116', 'description': 'Participants receive a single intramuscular (IM) injection of V116 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPSV23', 'description': 'Participants receive a single IM injection of PPSV23 on Day 1.', 'interventionNames': ['Biological: PPSV23']}], 'interventions': [{'name': 'V116', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 21-valent Conjugate Vaccine'], 'description': 'Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.', 'armGroupLabels': ['V116']}, {'name': 'PPSV23', 'type': 'BIOLOGICAL', 'otherNames': ['PNEUMOVAX™23'], 'description': 'Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.', 'armGroupLabels': ['PPSV23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '532-0003', 'city': 'Osaka', 'state': 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139.74491}}, {'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'PS Clinic ( Site 1002)', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '861-4157', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Nishikumamoto Hospital ( Site 1007)', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}