Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05464420
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2022-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
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': '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': 'Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days.', '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 according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.', 'eventGroups': [{'id': 'EG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.', 'otherNumAtRisk': 539, 'deathsNumAtRisk': 541, 'otherNumAffected': 428, 'seriousNumAtRisk': 539, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.', 'otherNumAtRisk': 536, 'deathsNumAtRisk': 540, 'otherNumAffected': 415, 'seriousNumAtRisk': 536, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.', 'otherNumAtRisk': 541, 'deathsNumAtRisk': 541, 'otherNumAffected': 421, 'seriousNumAtRisk': 541, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.', 'otherNumAtRisk': 541, 'deathsNumAtRisk': 540, 'otherNumAffected': 388, 'seriousNumAtRisk': 541, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 206, 'numAffected': 206}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 186, 'numAffected': 184}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 188, 'numAffected': 187}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 186, 'numAffected': 184}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 74, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 80, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 394, 'numAffected': 393}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 392, 'numAffected': 391}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 401, 'numAffected': 400}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 328, 'numAffected': 328}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 68, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 82, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 98, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 75, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 95, 'numAffected': 95}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 172, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 166, 'numAffected': 154}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 163, 'numAffected': 154}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 140, 'numAffected': 131}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oligodendroglioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 539, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '536', 'groupId': 'OG001'}, {'value': '541', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '16.5'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '17.4'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '16.3'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '76.6'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '76.7'}, {'value': '73.9', 'groupId': 'OG002', 'lowerLimit': '70.0', 'upperLimit': '77.6'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '15.5'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '18.6'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '14.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 incorrectly received V116 Lot 3 and one participant randomized into the V116 Lot 2 group incorrectly received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm incorrectly received PPSV23.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1616', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Combined Lots 1, 2, and 3', 'description': 'Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '3.0', 'ciUpperLimit': '8.6', 'groupDescription': 'Injection site erythema: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen \\& Nurminen method.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.6', 'ciLowerLimit': '8.0', 'ciUpperLimit': '17.3', 'groupDescription': 'Injection site pain: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '2.6', 'ciUpperLimit': '8.2', 'groupDescription': 'Injection site swelling: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '536', 'groupId': 'OG001'}, {'value': '541', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '33.9', 'upperLimit': '42.3'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '30.0', 'upperLimit': '38.1'}, {'value': '34.4', 'groupId': 'OG002', 'lowerLimit': '30.4', 'upperLimit': '38.6'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '24.3', 'upperLimit': '32.0'}, {'value': '26.1', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '30.1'}, {'value': '27.5', 'groupId': 'OG002', 'lowerLimit': '23.8', 'upperLimit': '31.5'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '21.7'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '16.8'}, {'value': '17.2', 'groupId': 'OG002', 'lowerLimit': '14.1', 'upperLimit': '20.6'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '5.0'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '3.9'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '5.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 incorrectly received V116 Lot 3 and one participant randomized into the V116 Lot 2 group incorrectly received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm incorrectly received PPSV23.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1616', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Combined Lots 1, 2, and 3', 'description': 'Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '6.0', 'groupDescription': 'Fatigue: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '1.6', 'ciUpperLimit': '9.7', 'groupDescription': 'Headache: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.6', 'ciLowerLimit': '4.5', 'ciUpperLimit': '10.5', 'groupDescription': 'Myalgia: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.1', 'groupDescription': 'Pyrexia: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '536', 'groupId': 'OG001'}, {'value': '541', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 194 days', 'description': 'An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 incorrectly received V116 Lot 3 and one participant randomized into the V116 Lot 2 group incorrectly received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm incorrectly received PPSV23.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1616', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Combined Lots 1, 2, and 3', 'description': 'Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'groupDescription': 'Vaccine-related SAEs: V116 Combined Lots - PPSV23', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimated difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 194 days', 'description': 'An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '525', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '327.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '299.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '318.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '524', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6901.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6014.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6641.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}, {'value': '527', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7219.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6201.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6657.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}, {'value': '528', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3935.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3812.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3765.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}, {'value': '531', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18747.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '17201.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18557.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}, {'value': '533', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7570.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7796.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7330.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}, {'value': '532', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6396.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6630.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6374.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}, {'value': '528', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7478.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6803.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7329.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}, {'value': '513', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10698.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10253.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10692.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}, {'value': '522', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13133.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11441.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11177.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}, {'value': '521', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9239.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9550.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9530.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}, {'value': '532', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17185.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '17718.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16886.7', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}, {'value': '533', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3187.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3123.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3368.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '525', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16339.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16676.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15302.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '529', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11638.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10614.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11346.7', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}, {'value': '520', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8437.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8459.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8322.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}, {'value': '527', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2964.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2435.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3035.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}, {'value': '524', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4861.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4783.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4758.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}, {'value': '522', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9052.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8831.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8870.7', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}, {'value': '526', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37994.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '34227.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35182.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '527', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12971.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12586.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12494.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.24', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/ V116 Lot 3', 'groupDescription': 'Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.06', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/ V116 Lot 3', 'groupDescription': 'Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3', 'statisticalMethod': 'cLDA Model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.35', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.22', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.06', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.34', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 7F: V116 Lot 1/ V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.25', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.07', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 8 V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/ V116 Lot 3', 'groupDescription': 'Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.14', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/ V116 Lot 3', 'groupDescription': 'Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.26', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.07', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.11', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.21', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.11', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.20', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.26', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.07', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.22', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.12', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.38', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.42', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.23', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.11', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.11', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.15', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.11', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.20', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.15', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.07', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.04', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.14', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.24', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.27', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.29', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.21', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.10', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cDLA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.19', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.19', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.48', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.19', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.97', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.20', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.20', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.33', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.29', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.17', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.14', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P value for testing the lower bound of the 95% CI for GMT ratio was \\>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \\<2.0.', 'nonInferiorityComment': 'Equivalence can be concluded if both the lower tailed and upper tailed p-values are \\< 0.025.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using 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 CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1617', 'groupId': 'OG000'}, {'value': '540', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Combined Lots 1, 2 and 3', 'description': 'Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1574', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '316.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '339.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1562', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6491.7', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1866.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1580', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6702.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5058.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1585', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3847.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4543.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1590', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18166.7', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '19031.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1586', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7618.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5763.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1581', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6494.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3728.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1583', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7196.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5207.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1520', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10520.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2608.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1571', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11922.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4112.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1563', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9415.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2532.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1588', 'groupId': 'OG000'}, {'value': '536', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17330.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10159.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3222.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3474.7', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1574', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16183.8', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10994.2', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1573', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11118.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8308.0', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1550', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8428.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1056.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1583', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2825.4', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '119.1', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1568', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4892.9', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '250.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1565', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8865.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '654.5', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1576', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35684.3', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '42515.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1578', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12798.6', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3452.1', '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': '0.93', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.03', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.48', 'ciLowerLimit': '3.01', 'ciUpperLimit': '4.02', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 6A: GMT Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.49', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.93', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 8: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.08', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.48', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 10A: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '1.56', 'ciUpperLimit': '1.95', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 11A: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '1.22', 'ciUpperLimit': '1.56', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 12F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.03', 'ciLowerLimit': '3.56', 'ciUpperLimit': '4.56', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 15A: GMT Ratio v116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.90', 'ciLowerLimit': '2.49', 'ciUpperLimit': '3.38', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 15C: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.72', 'ciLowerLimit': '3.32', 'ciUpperLimit': '4.17', 'groupDescription': 'Serotype 16F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '1.53', 'ciUpperLimit': '1.91', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 17F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.03', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 19A: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.30', 'ciUpperLimit': '1.67', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 20A: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.53', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 22F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.98', 'ciLowerLimit': '6.84', 'ciUpperLimit': '9.31', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 23A: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.72', 'ciLowerLimit': '19.71', 'ciUpperLimit': '28.55', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 23B: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.55', 'ciLowerLimit': '16.70', 'ciUpperLimit': '22.88', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 24F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.55', 'ciLowerLimit': '11.68', 'ciUpperLimit': '15.71', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 31: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.97', 'groupDescription': 'Serotype 33F: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.71', 'ciLowerLimit': '3.36', 'ciUpperLimit': '4.09', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 35B: GMT Ratio V116 Combined Lots / PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMT Ratio and 95% CI were estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.83', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.85', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.87', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.94', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.84', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.13', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.32', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.52', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.42', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.37', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.11', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.03', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.63', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.52', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.97', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.33', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.28', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.21', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.65', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.75', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.65', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.63', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.00', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.20', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.32', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.54', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.85', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.77', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.97', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.96', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.05', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.37', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.14', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.70', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.94', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.51', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.54', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.18', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.09', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.02', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.97', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.26', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.34', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.34', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.77', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.65', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.39', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.32', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.55', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.34', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.47', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.94', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.47', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.03', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.94', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.00', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '536', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.84', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11.56', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11.94', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.09', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.05', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.08', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.32', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.20', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.07', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.11', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.18', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.21', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.12', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.13', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.15', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.21', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.03', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.98', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.18', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.13', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.11', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 10A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.14', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.15', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.14', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.12', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.18', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.25', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 12F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.21', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.11', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.05', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 15A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.23', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.20', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.14', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 15C: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.03', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.04', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.15', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 16F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.21', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.23', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.17', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 17F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.11', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.04', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.07', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 19A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.10', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.10', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.16', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 20A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.16', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.16', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.15', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 22F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.16', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.15', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.17', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 23A: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.18', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.07', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.05', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 23B: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.13', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.19', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.25', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 24F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.00', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.14', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.30', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 31: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.16', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 2', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.15', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.13', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 33F: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.17', 'estimateComment': 'V116 Lot 1/V116 Lot 2', 'groupDescription': 'Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.13', 'estimateComment': 'V116 Lot 1/V116 Lot 3', 'groupDescription': 'Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.10', 'estimateComment': 'V116 Lot 2/V116 Lot 3', 'groupDescription': 'Serotype 35B: GMC Ratio V116 Lot 2/ V116 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1617', 'groupId': 'OG000'}, {'value': '540', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Combined Lots 1, 2, and 3', 'description': 'Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.'}, {'id': 'OG001', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.77', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.67', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.45', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.19', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.36', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.34', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.85', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.51', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.41', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.58', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.52', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.55', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.69', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.20', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.55', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.99', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.90', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.91', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.30', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.46', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.28', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.01', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.82', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.03', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.04', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.34', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.29', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.53', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.96', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.21', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.31', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.62', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.38', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.00', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.82', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1603', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.71', 'comment': 'NA means that per protocol, no within-group MOD were planned or calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.66', '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': '1.10', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.21', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 3: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.91', 'ciLowerLimit': '3.43', 'ciUpperLimit': '4.45', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.38', 'ciUpperLimit': '1.72', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.89', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.14', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.30', 'ciUpperLimit': '1.66', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.52', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.23', 'ciUpperLimit': '1.62', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.82', 'ciLowerLimit': '6.08', 'ciUpperLimit': '7.65', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.24', 'ciLowerLimit': '2.86', 'ciUpperLimit': '3.67', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.48', 'ciLowerLimit': '5.83', 'ciUpperLimit': '7.19', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '1.66', 'ciUpperLimit': '2.07', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.22', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.37', 'ciUpperLimit': '1.71', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.49', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.14', 'ciLowerLimit': '7.19', 'ciUpperLimit': '9.23', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.74', 'ciLowerLimit': '5.08', 'ciUpperLimit': '6.48', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were 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'ciLowerLimit': '0.73', 'ciUpperLimit': '0.91', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.06', 'ciLowerLimit': '6.41', 'ciUpperLimit': '7.77', 'estimateComment': 'V116 Combined Lots/PPSV23', 'groupDescription': 'Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC Ratio and 95% CI were estimated from a cLDA model.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '9.4'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '9.1'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '9.3'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '56.8'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '45.9'}, {'value': '35.8', 'groupId': 'OG002', 'lowerLimit': '29.7', 'upperLimit': '43.2'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '21.2'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '17.0'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': '17.6'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}, {'value': '466', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '21.1'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '19.2'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '18.5'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '11.7'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '12.0'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '12.2'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '16.7'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '18.0'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '13.3', 'upperLimit': '18.9'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '450', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '14.0'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '13.8'}, {'value': '9.3', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '11.1'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}, {'value': '432', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '173.7', 'groupId': 'OG000', 'lowerLimit': '144.8', 'upperLimit': '208.5'}, {'value': '152.0', 'groupId': 'OG001', 'lowerLimit': '127.5', 'upperLimit': '181.2'}, {'value': '194.1', 'groupId': 'OG002', 'lowerLimit': '162.5', 'upperLimit': '231.7'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '11.2'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '10.5'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '11.3'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '68.7', 'upperLimit': '107.8'}, {'value': '78.8', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '97.0'}, {'value': '63.8', 'groupId': 'OG002', 'lowerLimit': '51.2', 'upperLimit': '79.5'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '8.2'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.8'}, {'value': '6.9', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '7.8'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '20.9'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '21.6'}, {'value': '16.9', 'groupId': 'OG002', 'lowerLimit': '14.4', 'upperLimit': '19.8'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}, {'value': '468', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '10.3'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '9.9'}, {'value': '8.9', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '10.3'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '12.3'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '13.4'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '10.8'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '417', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '24.7'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '18.8'}, {'value': '18.1', 'groupId': 'OG002', 'lowerLimit': '14.9', 'upperLimit': '22.0'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '38.4'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '34.1'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '24.5', 'upperLimit': '36.7'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '444', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '104.1', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '127.2'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '111.2'}, {'value': '106.0', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '128.8'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '407', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '32.9'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '29.2'}, {'value': '25.4', 'groupId': 'OG002', 'lowerLimit': '20.8', 'upperLimit': '31.0'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '31.2'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '20.9', 'upperLimit': '31.6'}, {'value': '21.2', 'groupId': 'OG002', 'lowerLimit': '17.2', 'upperLimit': '26.1'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '425', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '15.2'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '14.5'}, {'value': '12.3', 'groupId': 'OG002', 'lowerLimit': '10.6', 'upperLimit': '14.2'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.2'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.7'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '5.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific OPA GMFR for all serotypes in V116 following vaccination were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '75.1'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '66.4', 'upperLimit': '75.2'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '66.1', 'upperLimit': '74.9'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '90.4'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '89.7'}, {'value': '85.6', 'groupId': 'OG002', 'lowerLimit': '81.8', 'upperLimit': '88.9'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '77.6'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '73.9'}, {'value': '71.7', 'groupId': 'OG002', 'lowerLimit': '67.2', 'upperLimit': '75.9'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}, {'value': '466', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '76.7'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '79.7'}, {'value': '70.4', 'groupId': 'OG002', 'lowerLimit': '66.0', 'upperLimit': '74.5'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '73.9'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '74.6'}, {'value': '72.1', 'groupId': 'OG002', 'lowerLimit': '67.6', 'upperLimit': '76.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '74.9'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '79.0'}, {'value': '73.8', 'groupId': 'OG002', 'lowerLimit': '69.5', 'upperLimit': '77.8'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}, {'value': '450', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '68.8'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '61.3', 'upperLimit': '70.4'}, {'value': '61.3', 'groupId': 'OG002', 'lowerLimit': '56.7', 'upperLimit': '65.9'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}, {'value': '432', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '96.4'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '92.0', 'upperLimit': '96.4'}, {'value': '95.6', 'groupId': 'OG002', 'lowerLimit': '93.2', 'upperLimit': '97.3'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '72.1'}, {'value': '66.2', 'groupId': 'OG001', 'lowerLimit': '60.7', 'upperLimit': '71.3'}, {'value': '67.5', 'groupId': 'OG002', 'lowerLimit': '62.1', 'upperLimit': '72.6'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '393', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': 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'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '85.5'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '84.9'}, {'value': '80.8', 'groupId': 'OG002', 'lowerLimit': '76.9', 'upperLimit': '84.3'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}, {'value': '468', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '60.6', 'upperLimit': '69.7'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '69.3'}, {'value': '66.2', 'groupId': 'OG002', 'lowerLimit': '61.8', 'upperLimit': '70.5'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': 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'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '83.8'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '74.9', 'upperLimit': '83.4'}, {'value': '82.1', 'groupId': 'OG002', 'lowerLimit': '77.7', 'upperLimit': '85.9'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '444', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '93.8'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '92.0'}, {'value': '90.3', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '92.9'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '407', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '82.8'}, {'value': '78.2', 'groupId': 'OG001', 'lowerLimit': '73.8', 'upperLimit': '82.2'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '72.2', 'upperLimit': '80.7'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '73.9', 'upperLimit': '82.4'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '74.8', 'upperLimit': '82.9'}, {'value': '77.6', 'groupId': 'OG002', 'lowerLimit': '73.2', 'upperLimit': '81.6'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '425', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '79.5'}, {'value': '73.2', 'groupId': 'OG001', 'lowerLimit': '68.7', 'upperLimit': '77.5'}, {'value': '75.1', 'groupId': 'OG002', 'lowerLimit': '70.7', 'upperLimit': '79.1'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '441', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '57.7'}, {'value': '49.5', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '54.3'}, {'value': '48.5', 'groupId': 'OG002', 'lowerLimit': '43.8', 'upperLimit': '53.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific OPA titer were determined using MOPA. The percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.8'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '5.2'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '5.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '24.1'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '21.5'}, {'value': 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'upperLimit': '17.0'}, {'value': '14.5', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '16.4'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '17.8'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '17.3'}, {'value': '17.1', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '19.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '16.8'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '17.1'}, {'value': '15.7', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '17.6'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '8.0'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '8.0'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '7.8'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '18.4'}, {'value': 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'upperLimit': '32.2'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '31.3'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '24.2', 'upperLimit': '30.9'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '9.3'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '9.9'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '10.1'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '26.3'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '25.9'}, {'value': '21.5', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '24.1'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.1'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.4'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '6.7'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '504', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '10.3'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '10.9'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '10.9'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '23.3'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '22.0'}, {'value': '19.4', 'groupId': 'OG002', 'lowerLimit': '17.0', 'upperLimit': '22.2'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '504', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '22.8'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '22.5'}, {'value': '20.3', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '22.9'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '15.7'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '16.0'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '17.1'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '16.6'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '17.5'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '16.6'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '15.0'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '17.5'}, {'value': '13.0', 'groupId': 'OG002', 'lowerLimit': '11.7', 'upperLimit': '14.5'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '9.8'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '10.1'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '10.0'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '8.1'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.1'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '8.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific IgG GMFR for all serotypes in V116 following vaccination were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '56.3'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '49.9', 'upperLimit': '58.8'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '47.5', 'upperLimit': '56.4'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '90.6'}, {'value': '85.3', 'groupId': 'OG001', 'lowerLimit': '81.9', 'upperLimit': '88.2'}, {'value': '89.3', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '91.9'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '86.4'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '80.6', 'upperLimit': '87.2'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '79.0', 'upperLimit': '85.8'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '76.8', 'upperLimit': '83.9'}, {'value': '82.7', 'groupId': 'OG001', 'lowerLimit': '79.1', 'upperLimit': '85.9'}, {'value': '81.4', 'groupId': 'OG002', 'lowerLimit': '77.8', 'upperLimit': '84.7'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '88.9'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '80.6', 'upperLimit': '87.2'}, {'value': '82.8', 'groupId': 'OG002', 'lowerLimit': '79.2', 'upperLimit': '86.0'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '86.0'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '85.7'}, {'value': '83.4', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '86.5'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '71.5'}, {'value': '67.3', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '71.4'}, {'value': '63.8', 'groupId': 'OG002', 'lowerLimit': '59.5', 'upperLimit': '68.0'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '80.3', 'upperLimit': '86.9'}, {'value': '85.1', 'groupId': 'OG001', 'lowerLimit': '81.6', 'upperLimit': '88.1'}, {'value': '84.4', 'groupId': 'OG002', 'lowerLimit': '80.9', 'upperLimit': '87.4'}]}]}, {'title': 'Serotype 15A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '88.2', 'upperLimit': '93.4'}, {'value': '89.2', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '91.8'}, {'value': '90.3', 'groupId': 'OG002', 'lowerLimit': '87.4', 'upperLimit': '92.7'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '93.3'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '88.0', 'upperLimit': '93.2'}, {'value': '90.1', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '92.6'}]}]}, {'title': 'Serotype 16F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '77.1'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '68.4', 'upperLimit': '76.4'}, {'value': '74.7', 'groupId': 'OG002', 'lowerLimit': '70.6', 'upperLimit': '78.4'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '92.7'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '93.4'}, {'value': '87.7', 'groupId': 'OG002', 'lowerLimit': '84.6', 'upperLimit': '90.5'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '62.9'}, {'value': '58.6', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '62.9'}, {'value': '59.3', 'groupId': 'OG002', 'lowerLimit': '54.9', 'upperLimit': '63.6'}]}]}, {'title': 'Serotype 20A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '504', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '68.7', 'upperLimit': '76.7'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '79.8'}, {'value': '74.8', 'groupId': 'OG002', 'lowerLimit': '70.8', 'upperLimit': '78.5'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '87.3'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '75.7', 'upperLimit': '82.9'}, {'value': '84.2', 'groupId': 'OG002', 'lowerLimit': '80.7', 'upperLimit': '87.3'}]}]}, {'title': 'Serotype 23A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '504', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '91.6'}, {'value': '88.8', 'groupId': 'OG001', 'lowerLimit': '85.8', 'upperLimit': '91.5'}, {'value': '86.3', 'groupId': 'OG002', 'lowerLimit': '83.0', 'upperLimit': '89.2'}]}]}, {'title': 'Serotype 23B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '73.7', 'upperLimit': '81.2'}, {'value': '77.1', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '80.7'}, {'value': '78.6', 'groupId': 'OG002', 'lowerLimit': '74.8', 'upperLimit': '82.1'}]}]}, {'title': 'Serotype 24F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '506', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '77.4', 'upperLimit': '84.5'}, {'value': '80.9', 'groupId': 'OG001', 'lowerLimit': '77.2', 'upperLimit': '84.2'}, {'value': '79.6', 'groupId': 'OG002', 'lowerLimit': '75.9', 'upperLimit': '83.1'}]}]}, {'title': 'Serotype 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '88.7'}, {'value': '84.3', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '87.3'}, {'value': '82.4', 'groupId': 'OG002', 'lowerLimit': '78.8', 'upperLimit': '85.6'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '77.3'}, {'value': '71.7', 'groupId': 'OG001', 'lowerLimit': '67.6', 'upperLimit': '75.6'}, {'value': '73.7', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '77.5'}]}]}, {'title': 'Serotype 35B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '505', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': '71.9'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '70.8'}, {'value': '64.2', 'groupId': 'OG002', 'lowerLimit': '59.8', 'upperLimit': '68.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific IgG concentrations were determined using PnECL. The percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'OG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'OG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'OG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'classes': [{'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '442', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6849.6', 'groupId': 'OG000', 'lowerLimit': '6120.8', 'upperLimit': '7665.0'}, {'value': '6009.2', 'groupId': 'OG001', 'lowerLimit': '5348.8', 'upperLimit': '6751.0'}, {'value': '6724.3', 'groupId': 'OG002', 'lowerLimit': '5967.6', 'upperLimit': '7577.0'}]}]}, {'title': 'Serotype 6C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '438', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3972.7', 'groupId': 'OG000', 'lowerLimit': '3501.8', 'upperLimit': '4506.9'}, {'value': '3421.5', 'groupId': 'OG001', 'lowerLimit': '3006.5', 'upperLimit': '3893.8'}, {'value': '3750.9', 'groupId': 'OG002', 'lowerLimit': '3298.0', 'upperLimit': '4265.9'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}, {'value': '417', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11799.5', 'groupId': 'OG000', 'lowerLimit': '10317.9', 'upperLimit': '13493.8'}, {'value': '10062.4', 'groupId': 'OG001', 'lowerLimit': '8838.3', 'upperLimit': '11456.1'}, {'value': '11139.5', 'groupId': 'OG002', 'lowerLimit': '9619.7', 'upperLimit': '12899.4'}]}]}, {'title': 'Serotype 15C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '422', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13079.8', 'groupId': 'OG000', 'lowerLimit': '11543.5', 'upperLimit': '14820.6'}, {'value': '11332.5', 'groupId': 'OG001', 'lowerLimit': '9905.9', 'upperLimit': '12964.7'}, {'value': '11290.9', 'groupId': 'OG002', 'lowerLimit': '9805.6', 'upperLimit': '13001.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'Serotype-specific OPA titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'FG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'FG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'FG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '541'}, {'groupId': 'FG001', 'numSubjects': '540'}, {'groupId': 'FG002', 'numSubjects': '541'}, {'groupId': 'FG003', 'numSubjects': '540'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '539'}, {'groupId': 'FG001', 'numSubjects': '538'}, {'groupId': 'FG002', 'numSubjects': '540'}, {'groupId': 'FG003', 'numSubjects': '540'}]}, {'type': 'Safety Analysis Population', 'comment': 'One participant initially randomized to the V116 Lot 2 arm received V116 Lot 1, one participant initially randomized to the V116 Lot 1 arm received V116 Lot 3, and one participant initially randomized to the V116 Lot 2 arm received PPSV23.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '539'}, {'groupId': 'FG001', 'numSubjects': '536'}, {'groupId': 'FG002', 'numSubjects': '541'}, {'groupId': 'FG003', 'numSubjects': '541'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '521'}, {'groupId': 'FG001', 'numSubjects': '520'}, {'groupId': 'FG002', 'numSubjects': '525'}, {'groupId': 'FG003', 'numSubjects': '526'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Randomized in Error Without Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unable to Adhere to Study Schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy pneumococcal vaccine-naïve adults between 18 and 49 years of age were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'BG000'}, {'value': '540', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}, {'value': '2162', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'V116 Lot 1', 'description': 'Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.'}, {'id': 'BG001', 'title': 'V116 Lot 2', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.'}, {'id': 'BG002', 'title': 'V116 Lot 3', 'description': 'Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.'}, {'id': 'BG003', 'title': 'PPSV23', 'description': 'Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '34.4', 'spread': '9.2', 'groupId': 'BG003'}, {'value': '34.6', 'spread': '9.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}, {'value': '1247', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '915', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '422', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '440', 'groupId': 'BG000'}, {'value': '434', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}, {'value': '430', 'groupId': 'BG003'}, {'value': '1724', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '195', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}, {'value': '453', 'groupId': 'BG003'}, {'value': '1827', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-21', 'size': 871923, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-26T13:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2022-07-12', 'resultsFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-26', 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23', 'timeFrame': 'Up to 5 days', 'description': 'An AE was 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 aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.'}, {'measure': 'Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots', 'timeFrame': 'Up to 194 days', 'description': 'An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23', 'timeFrame': 'Up to 194 days', 'description': 'An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated.'}, {'measure': 'Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'timeFrame': 'Day 30', 'description': 'Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using 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 CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}], 'secondaryOutcomes': [{'measure': 'GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23', 'timeFrame': 'Day 30', 'description': 'Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'timeFrame': 'Day 30', 'description': 'Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23', 'timeFrame': 'Day 30', 'description': 'Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific OPA GMFR for all serotypes in V116 following vaccination were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific OPA titer were determined using MOPA. The percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific IgG GMFR for all serotypes in V116 following vaccination were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots', 'timeFrame': 'Baseline (Day 1) and Day 30', 'description': 'Serotype-specific IgG concentrations were determined using PnECL. The percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}, {'measure': 'GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots', 'timeFrame': 'Day 30', 'description': 'Serotype-specific OPA titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'referencesModule': {'references': [{'pmid': '40543503', 'type': 'DERIVED', 'citation': 'Scott P, Ukkonen B, Caraco Y, Perez SN, Alpizar SA, Cardona JF, Greenberg D, Grijalva CG, Orenstein W, Wiedmann RT, Fernsler D, Cheon K, Li J, Platt HL. A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med. 2025 Oct 10;6(10):100748. doi: 10.1016/j.medj.2025.100748. Epub 2025 Jun 20.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26086&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.\n\nThe primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has underlying chronic conditions but assessed to be stable as per investigator\n* Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator\n\nExclusion Criteria:\n\n* Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)\n* Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease\n* Has a coagulation disorder contraindicating intramuscular vaccination\n* Has a recent illness with fever\n* Has a known malignancy that is progressing or has required active treatment \\<3 years before enrollment\n* Is expected to receive any pneumococcal vaccine during the study outside of the protocol\n* Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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* Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine\n* Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine\n* Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine'}, 'identificationModule': {'nctId': 'NCT05464420', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age', 'orgStudyIdInfo': {'id': 'V116-004'}, 'secondaryIdInfos': [{'id': '2022-000265-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V116 Lot 1', 'description': 'Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'EXPERIMENTAL', 'label': 'V116 Lot 2', 'description': 'Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'EXPERIMENTAL', 'label': 'V116 Lot 3', 'description': 'Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPSV23', 'description': 'Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.', 'interventionNames': ['Biological: PPSV23']}], 'interventions': [{'name': 'V116', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 21-valent Conjugate Vaccine'], 'description': 'Pneumococcal 21-valent conjugate vaccine with 4 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 Lot 1', 'V116 Lot 2', 'V116 Lot 3']}, {'name': 'PPSV23', 'type': 'BIOLOGICAL', 'otherNames': ['PNEUMOVAX™23'], 'description': 'Pneumococcal 23-valent conjugate 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': ['PPSV23']}]}, 'contactsLocationsModule': 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