Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT04665050
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
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@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. 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 62 days postvaccination.', 'description': 'The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 30, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 35, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Injection-site Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '13.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '12.7', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Injection Site Erythema', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and confidence interval (CI) are calculated based on the Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.8', 'ciLowerLimit': '-30.0', 'ciUpperLimit': '7.3', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Injection Site Pain', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '14.1', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Injection Site Swelling', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}], '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. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study vaccination'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Systemic AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '17.5', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Fatigue', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '9.9', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Arthralgia', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '13.6', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Myalgia', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '12.7', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'groupDescription': 'Headache', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}], '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. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study vaccination'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '7.1', 'estimateComment': 'V116 minus PNEUMOVAX™23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference and CI are calculated based on the Miettinen \\& Nurminen method'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 62 days postvaccination', 'description': 'An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study vaccination'}, {'type': 'SECONDARY', 'title': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '161.08', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '100.76', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '5327.67', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4406.11', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '1479.82', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '738.52', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'categories': [{'measurements': [{'value': '5768.79', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3000.50', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'categories': [{'measurements': [{'value': '33187.25', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '28831.77', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'categories': [{'measurements': [{'value': '1287.66', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '721.85', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'categories': [{'measurements': [{'value': '6555.82', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3466.72', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'categories': [{'measurements': [{'value': '3608.34', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1330.75', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'categories': [{'measurements': [{'value': '1467.66', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '603.00', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'categories': [{'measurements': [{'value': '1356.20', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '563.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'categories': [{'measurements': [{'value': '8470.21', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3293.31', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'categories': [{'measurements': [{'value': '3542.90', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1553.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '1.07', 'ciUpperLimit': '2.40', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 3', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.11', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 7F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '1.24', 'ciUpperLimit': '3.24', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 19A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.04', 'ciUpperLimit': '3.57', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 22F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.86', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 33F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '1.24', 'ciUpperLimit': '2.58', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 8', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.89', 'ciLowerLimit': '1.19', 'ciUpperLimit': '3.00', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 9N', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.71', 'ciLowerLimit': '1.47', 'ciUpperLimit': '5.00', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 10A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.52', 'ciUpperLimit': '3.89', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 11A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '1.20', 'ciUpperLimit': '4.83', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 12F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.57', 'ciLowerLimit': '1.59', 'ciUpperLimit': '4.17', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 17F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.28', 'ciLowerLimit': '1.46', 'ciUpperLimit': '3.56', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 20A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% confidence interval CI are estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses'}, {'type': 'SECONDARY', 'title': 'Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.13', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.73', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '10.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.66', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '10.75', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.97', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'categories': [{'measurements': [{'value': '3.94', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.69', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'categories': [{'measurements': [{'value': '22.00', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.48', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'categories': [{'measurements': [{'value': '19.38', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.33', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'categories': [{'measurements': [{'value': '14.17', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'categories': [{'measurements': [{'value': '11.13', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.16', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'categories': [{'measurements': [{'value': '9.07', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.71', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'categories': [{'measurements': [{'value': '2.87', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.82', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'categories': [{'measurements': [{'value': '19.46', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.77', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'categories': [{'measurements': [{'value': '23.53', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11.46', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.21', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 3', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.36', 'ciUpperLimit': '3.60', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 7F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.16', 'ciLowerLimit': '1.45', 'ciUpperLimit': '3.23', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 19A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '1.36', 'ciUpperLimit': '3.99', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 22F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.37', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 33F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '1.32', 'ciUpperLimit': '2.68', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 8', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.37', 'ciLowerLimit': '1.49', 'ciUpperLimit': '3.74', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 9N', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.16', 'ciLowerLimit': '1.28', 'ciUpperLimit': '3.65', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 10A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.89', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 11A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.49', 'ciLowerLimit': '1.94', 'ciUpperLimit': '6.27', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 12F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.88', 'ciLowerLimit': '1.92', 'ciUpperLimit': '4.31', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 17F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.30', 'ciUpperLimit': '3.25', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 20A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses'}, {'type': 'SECONDARY', 'title': 'Serotype-specific OPA GMTs for the Unique Serotypes in V116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '1663.20', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '464.65', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'categories': [{'measurements': [{'value': '5030.66', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '807.16', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'categories': [{'measurements': [{'value': '3641.84', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1565.56', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'categories': [{'measurements': [{'value': '2459.26', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '244.49', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'categories': [{'measurements': [{'value': '2620.19', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '62.26', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'categories': [{'measurements': [{'value': '2065.39', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '167.03', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'categories': [{'measurements': [{'value': '2742.93', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '110.53', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'categories': [{'measurements': [{'value': '1699.54', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '66.24', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'categories': [{'measurements': [{'value': '4992.58', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '349.07', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.58', 'ciLowerLimit': '1.86', 'ciUpperLimit': '6.88', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 6A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.23', 'ciLowerLimit': '3.54', 'ciUpperLimit': '10.98', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 15A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.33', 'ciLowerLimit': '1.23', 'ciUpperLimit': '4.39', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 15C', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.06', 'ciLowerLimit': '5.39', 'ciUpperLimit': '18.78', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 16F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.09', 'ciLowerLimit': '19.67', 'ciUpperLimit': '90.03', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 23A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.37', 'ciLowerLimit': '6.97', 'ciUpperLimit': '21.94', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 23B', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.82', 'ciLowerLimit': '11.65', 'ciUpperLimit': '52.86', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 24F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.66', 'ciLowerLimit': '14.65', 'ciUpperLimit': '44.93', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 31', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.30', 'ciLowerLimit': '8.72', 'ciUpperLimit': '23.47', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 35B', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMT ratio and 95% CI are estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses'}, {'type': 'SECONDARY', 'title': 'Serotype-specific IgG GMCs for the Unique Serotypes in V116', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '6.38', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.13', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'categories': [{'measurements': [{'value': '16.39', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.04', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'categories': [{'measurements': [{'value': '21.42', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.81', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'categories': [{'measurements': [{'value': '5.57', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.43', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'categories': [{'measurements': [{'value': '4.14', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.48', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'categories': [{'measurements': [{'value': '8.56', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.06', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'categories': [{'measurements': [{'value': '13.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.49', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'categories': [{'measurements': [{'value': '5.25', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.51', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'categories': [{'measurements': [{'value': '24.61', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.54', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.00', 'ciLowerLimit': '1.73', 'ciUpperLimit': '5.19', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 6A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.03', 'ciLowerLimit': '4.61', 'ciUpperLimit': '13.98', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 15A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.14', 'ciLowerLimit': '1.77', 'ciUpperLimit': '5.58', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 15C', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.06', 'ciLowerLimit': '8.45', 'ciUpperLimit': '20.19', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 16F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.55', 'ciLowerLimit': '5.19', 'ciUpperLimit': '14.09', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 23A', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.15', 'ciLowerLimit': '2.72', 'ciUpperLimit': '6.36', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 23B', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.68', 'ciLowerLimit': '16.59', 'ciUpperLimit': '49.58', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 24F', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.27', 'ciLowerLimit': '6.71', 'ciUpperLimit': '15.73', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 31', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.95', 'ciLowerLimit': '11.62', 'ciUpperLimit': '21.90', 'estimateComment': 'V116/PNEUMOVAX™23', 'groupDescription': 'Serotype 35B', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'GMC ratio and 95% CI are estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 postvaccination', 'description': 'The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '7.07', 'upperLimit': '13.75'}, {'value': '6.35', 'groupId': 'OG001', 'lowerLimit': '4.43', 'upperLimit': '9.10'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.79', 'groupId': 'OG000', 'lowerLimit': '10.60', 'upperLimit': '36.94'}, {'value': '21.53', 'groupId': 'OG001', 'lowerLimit': '11.79', 'upperLimit': '39.30'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.80', 'groupId': 'OG000', 'lowerLimit': '7.27', 'upperLimit': '16.04'}, {'value': '6.74', 'groupId': 'OG001', 'lowerLimit': '4.45', 'upperLimit': '10.18'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.14', 'groupId': 'OG000', 'lowerLimit': '8.25', 'upperLimit': '27.79'}, {'value': '18.13', 'groupId': 'OG001', 'lowerLimit': '9.17', 'upperLimit': '35.85'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.47', 'groupId': 'OG000', 'lowerLimit': '8.20', 'upperLimit': '16.04'}, {'value': '11.62', 'groupId': 'OG001', 'lowerLimit': '7.91', 'upperLimit': '17.06'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.33', 'groupId': 'OG000', 'lowerLimit': '75.07', 'upperLimit': '139.50'}, {'value': '48.14', 'groupId': 'OG001', 'lowerLimit': '32.69', 'upperLimit': '70.88'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.49', 'groupId': 'OG000', 'lowerLimit': '31.26', 'upperLimit': '98.50'}, {'value': '40.11', 'groupId': 'OG001', 'lowerLimit': '22.97', 'upperLimit': '70.03'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.29', 'groupId': 'OG000', 'lowerLimit': '15.34', 'upperLimit': '63.81'}, {'value': '21.93', 'groupId': 'OG001', 'lowerLimit': '12.29', 'upperLimit': '39.11'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.06', 'groupId': 'OG000', 'lowerLimit': '25.15', 'upperLimit': '70.32'}, {'value': '20.68', 'groupId': 'OG001', 'lowerLimit': '12.11', 'upperLimit': '35.33'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.74', 'groupId': 'OG000', 'lowerLimit': '54.15', 'upperLimit': '165.76'}, {'value': '44.70', 'groupId': 'OG001', 'lowerLimit': '24.59', 'upperLimit': '81.24'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.63', 'groupId': 'OG000', 'lowerLimit': '13.40', 'upperLimit': '41.68'}, {'value': '11.40', 'groupId': 'OG001', 'lowerLimit': '7.07', 'upperLimit': '18.40'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.69', 'groupId': 'OG000', 'lowerLimit': '7.27', 'upperLimit': '18.81'}, {'value': '5.94', 'groupId': 'OG001', 'lowerLimit': '4.12', 'upperLimit': '8.57'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.76', 'groupId': 'OG000', 'lowerLimit': '12.66', 'upperLimit': '40.93'}, {'value': '8.31', 'groupId': 'OG001', 'lowerLimit': '5.24', 'upperLimit': '13.17'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.70', 'groupId': 'OG000', 'lowerLimit': '6.31', 'upperLimit': '18.13'}, {'value': '3.02', 'groupId': 'OG001', 'lowerLimit': '1.67', 'upperLimit': '5.43'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.53', 'groupId': 'OG000', 'lowerLimit': '18.49', 'upperLimit': '72.15'}, {'value': '16.72', 'groupId': 'OG001', 'lowerLimit': '9.39', 'upperLimit': '29.76'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.74', 'groupId': 'OG000', 'lowerLimit': '8.27', 'upperLimit': '26.28'}, {'value': '1.84', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '3.06'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.69', 'groupId': 'OG000', 'lowerLimit': '25.58', 'upperLimit': '85.22'}, {'value': '1.93', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '3.56'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.21', 'groupId': 'OG000', 'lowerLimit': '25.15', 'upperLimit': '74.23'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '6.54'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.21', 'groupId': 'OG000', 'lowerLimit': '5.06', 'upperLimit': '16.78'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '1.40'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.99', 'groupId': 'OG000', 'lowerLimit': '16.04', 'upperLimit': '48.85'}, {'value': '1.22', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '2.01'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.39', 'groupId': 'OG000', 'lowerLimit': '4.32', 'upperLimit': '12.67'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.78'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.63', 'groupId': 'OG000', 'lowerLimit': '3.17', 'upperLimit': '9.99'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.21', 'upperLimit': '7.24'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.68', 'groupId': 'OG000', 'lowerLimit': '18.43', 'upperLimit': '69.08'}, {'value': '23.54', 'groupId': 'OG001', 'lowerLimit': '13.35', 'upperLimit': '41.50'}]}]}, {'title': 'Serotype 20B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.08', 'groupId': 'OG000', 'lowerLimit': '3.16', 'upperLimit': '11.71'}, {'value': '8.89', 'groupId': 'OG001', 'lowerLimit': '5.29', 'upperLimit': '14.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype'}, {'type': 'SECONDARY', 'title': 'GMFR From Baseline in Serotype-specific IgG GMCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'OG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.92', 'groupId': 'OG000', 'lowerLimit': '4.25', 'upperLimit': '8.24'}, {'value': '4.47', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '5.74'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.86', 'groupId': 'OG000', 'lowerLimit': '16.20', 'upperLimit': '35.14'}, {'value': '10.51', 'groupId': 'OG001', 'lowerLimit': '7.57', 'upperLimit': '14.58'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.58', 'groupId': 'OG000', 'lowerLimit': '5.51', 'upperLimit': '10.44'}, {'value': '3.52', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '4.56'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.68', 'groupId': 'OG000', 'lowerLimit': '9.24', 'upperLimit': '23.30'}, {'value': '6.57', 'groupId': 'OG001', 'lowerLimit': '4.65', 'upperLimit': '9.28'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.61', 'groupId': 'OG000', 'lowerLimit': '14.49', 'upperLimit': '32.23'}, {'value': '11.52', 'groupId': 'OG001', 'lowerLimit': '8.24', 'upperLimit': '16.13'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.58', 'groupId': 'OG000', 'lowerLimit': '22.46', 'upperLimit': '44.39'}, {'value': '16.71', 'groupId': 'OG001', 'lowerLimit': '12.61', 'upperLimit': '22.14'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.26', 'groupId': 'OG000', 'lowerLimit': '16.60', 'upperLimit': '35.46'}, {'value': '10.56', 'groupId': 'OG001', 'lowerLimit': '8.01', 'upperLimit': '13.92'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.70', 'groupId': 'OG000', 'lowerLimit': '10.45', 'upperLimit': '23.59'}, {'value': '7.19', 'groupId': 'OG001', 'lowerLimit': '5.13', 'upperLimit': '10.07'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.31', 'groupId': 'OG000', 'lowerLimit': '6.51', 'upperLimit': '13.31'}, {'value': '4.64', 'groupId': 'OG001', 'lowerLimit': '3.47', 'upperLimit': '6.22'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.87', 'groupId': 'OG000', 'lowerLimit': '15.22', 'upperLimit': '37.44'}, {'value': '6.53', 'groupId': 'OG001', 'lowerLimit': '4.52', 'upperLimit': '9.44'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.71', 'groupId': 'OG000', 'lowerLimit': '15.14', 'upperLimit': '28.33'}, {'value': '7.37', 'groupId': 'OG001', 'lowerLimit': '5.60', 'upperLimit': '9.69'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.68', 'groupId': 'OG000', 'lowerLimit': '8.14', 'upperLimit': '16.77'}, {'value': '6.19', 'groupId': 'OG001', 'lowerLimit': '4.57', 'upperLimit': '8.38'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.01', 'groupId': 'OG000', 'lowerLimit': '8.99', 'upperLimit': '21.86'}, {'value': '4.67', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '6.63'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.11', 'groupId': 'OG000', 'lowerLimit': '18.79', 'upperLimit': '54.89'}, {'value': '3.34', 'groupId': 'OG001', 'lowerLimit': '2.52', 'upperLimit': '4.44'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.20', 'groupId': 'OG000', 'lowerLimit': '25.71', 'upperLimit': '69.25'}, {'value': '11.50', 'groupId': 'OG001', 'lowerLimit': '7.83', 'upperLimit': '16.88'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.00', 'groupId': 'OG000', 'lowerLimit': '14.13', 'upperLimit': '31.23'}, {'value': '1.52', 'groupId': 'OG001', 'lowerLimit': '1.33', 'upperLimit': '1.73'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.42', 'groupId': 'OG000', 'lowerLimit': '12.28', 'upperLimit': '27.63'}, {'value': '2.26', 'groupId': 'OG001', 'lowerLimit': '1.67', 'upperLimit': '3.06'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.04', 'groupId': 'OG000', 'lowerLimit': '9.14', 'upperLimit': '21.58'}, {'value': '3.22', 'groupId': 'OG001', 'lowerLimit': '2.55', 'upperLimit': '4.06'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.58', 'groupId': 'OG000', 'lowerLimit': '18.26', 'upperLimit': '54.60'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.31'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.97', 'groupId': 'OG000', 'lowerLimit': '12.37', 'upperLimit': '26.10'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '1.28', 'upperLimit': '2.09'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.93', 'groupId': 'OG000', 'lowerLimit': '11.99', 'upperLimit': '23.90'}, {'value': '1.10', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.15'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.94', 'groupId': 'OG000', 'lowerLimit': '4.25', 'upperLimit': '8.30'}, {'value': '2.21', 'groupId': 'OG001', 'lowerLimit': '1.79', 'upperLimit': '2.74'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.14', 'groupId': 'OG000', 'lowerLimit': '7.39', 'upperLimit': '16.78'}, {'value': '8.61', 'groupId': 'OG001', 'lowerLimit': '6.14', 'upperLimit': '12.08'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'FG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V116', 'description': 'Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.'}, {'id': 'BG001', 'title': 'PNEUMOVAX™23', 'description': 'Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.1', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'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': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-20', 'size': 1269972, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-04T09:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2020-12-08', 'resultsFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-04', 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Solicited Injection-site Adverse Event (AE)', '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. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.'}, {'measure': 'Percentage of Participants With a Solicited Systemic AE', '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. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)', 'timeFrame': 'Up to 62 days postvaccination', 'description': 'An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.'}], 'secondaryOutcomes': [{'measure': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated.'}, {'measure': 'Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23', 'timeFrame': 'Day 30 postvaccination', 'description': 'The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.'}, {'measure': 'Serotype-specific OPA GMTs for the Unique Serotypes in V116', 'timeFrame': 'Day 30 postvaccination', 'description': 'The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.'}, {'measure': 'Serotype-specific IgG GMCs for the Unique Serotypes in V116', 'timeFrame': 'Day 30 postvaccination', 'description': 'The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.'}, {'measure': 'GMFR From Baseline in Serotype-specific IgG GMCs', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infection']}, 'referencesModule': {'references': [{'pmid': '37389808', 'type': 'RESULT', 'citation': 'Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* is a healthy Japanese male or female ≥20 years of age at time of randomization\n* male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention\n* female participants must not be pregnant or breastfeeding, and is either:\n* not a woman of childbearing potential (WOCBP) or\n* a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention\n\nExclusion Criteria:\n\n* has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1\n* has a known hypersensitivity to any vaccine components\n* has impaired immunological function\n* has a coagulation disorder\n* had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1\n* has a known malignancy that is progressing/requiring treatment\n* has received, or is expected to receive, a pneumococcal vaccine outside the study protocol\n* has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1\n* is receiving immunosuppressive therapy\n* has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine\n* has received any live vaccine from 30 days prior to Day 1\n* has received a blood transfusion or blood products\n* has participated in another clinical trial within 2 months of this study\n* has clinically relevant drug or alcohol abuse\n* has any condition that, in the opinion of the investigator, precludes participation in this study'}, 'identificationModule': {'nctId': 'NCT04665050', 'briefTitle': 'Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.', 'orgStudyIdInfo': {'id': 'pPCV-002'}, 'secondaryIdInfos': [{'id': 'pPCV-002', 'type': 'OTHER', 'domain': 'Merck'}, {'id': 'jRCT2071200094', 'type': 'REGISTRY', 'domain': 'jRCT'}, {'id': 'V116-002', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V116', 'description': 'Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PNEUMOVAX™23', 'description': 'Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.', 'interventionNames': ['Biological: PNEUMOVAX™23']}], 'interventions': [{'name': 'V116', 'type': 'BIOLOGICAL', 'otherNames': ['Polyvalent pneumococcal conjugate vaccine (pPCV)', 'Pneumococcal 21-valent Conjugate Vaccine'], 'description': 'Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution', 'armGroupLabels': ['V116']}, {'name': 'PNEUMOVAX™23', 'type': 'BIOLOGICAL', 'otherNames': ['PPSV23'], 'description': 'Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution', 'armGroupLabels': ['PNEUMOVAX™23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Souseikai PS Clinic ( Site 0201)', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '861-4157', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Souseikai Nishikumamoto Hospital ( Site 0202)', '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'}}}}