Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT03950856
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2019-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D011018', 'term': 'Pneumonia, Pneumococcal'}], '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'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Non-serious adverse events (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.', 'description': 'For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.', 'eventGroups': [{'id': 'EG000', 'title': 'V114 Lot 1', 'description': 'Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)', 'otherNumAtRisk': 699, 'deathsNumAtRisk': 702, 'otherNumAffected': 548, 'seriousNumAtRisk': 699, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)', 'otherNumAtRisk': 704, 'deathsNumAtRisk': 704, 'otherNumAffected': 534, 'seriousNumAtRisk': 704, 'deathsNumAffected': 2, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)', 'otherNumAtRisk': 700, 'deathsNumAtRisk': 701, 'otherNumAffected': 535, 'seriousNumAtRisk': 700, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Prevnar 13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 233, 'otherNumAffected': 151, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 202, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 182, 'numAffected': 147}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 189, 'numAffected': 151}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 74, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 82, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 91, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 91, 'numAffected': 89}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 518, 'numAffected': 464}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 520, 'numAffected': 475}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 514, 'numAffected': 471}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 134, 'numAffected': 122}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 115, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 117, 'numAffected': 115}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 109, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 68, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 54, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 75, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 226, 'numAffected': 196}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 196, 'numAffected': 171}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 226, 'numAffected': 199}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 54, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 166, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 170, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 171, 'numAffected': 130}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 53, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Death', 'notes': 'Due to unknown cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 699, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 704, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 700, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '12.6'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '14.1'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '13.6'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '69.6'}, {'value': '67.0', 'groupId': 'OG001', 'lowerLimit': '63.4', 'upperLimit': '70.5'}, {'value': '67.3', 'groupId': 'OG002', 'lowerLimit': '63.7', 'upperLimit': '70.8'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '18.5'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '18.7'}, {'value': '14.7', 'groupId': 'OG002', 'lowerLimit': '12.2', 'upperLimit': '17.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 5', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2103', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Combined Lots 1,2 and 3', 'description': 'Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.538', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '4.8', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Injection site erythema: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '7.9', 'ciUpperLimit': '21.4', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Injection site pain: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.686', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '5.3', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Injection site swelling: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 5', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '9.8'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '9.1'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '10.7'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '25.3'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '24.1'}, {'value': '21.6', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '24.8'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '21.2'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '23.0'}, {'value': '18.6', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '21.7'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '31.5'}, {'value': '24.3', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '27.6'}, {'value': '28.4', 'groupId': 'OG002', 'lowerLimit': '25.1', 'upperLimit': '31.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 14', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2103', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Combined Lots 1,2 and 3', 'description': 'Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.272', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '4.7', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Arthralgia: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.812', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '4.5', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Fatigue: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.947', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '5.0', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Headache: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '10.4', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'Myalgia: V114 Combined Lots - Prevnar 13™', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 14', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 6', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2103', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Combined Lots 1,2 and 3', 'description': 'Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Miettinen & Nurminen', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.2', 'estimateComment': 'V114 Combined Lots minus Prevnar 13™', 'groupDescription': 'V114 Combined Lots - Prevnar 13™', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 6', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '248.5', 'groupId': 'OG000'}, {'value': '251.6', 'groupId': 'OG001'}, {'value': '239.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '198.3', 'groupId': 'OG000'}, {'value': '232.2', 'groupId': 'OG001'}, {'value': '214.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1073.1', 'groupId': 'OG000'}, {'value': '1303.7', 'groupId': 'OG001'}, {'value': '1074.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '389.8', 'groupId': 'OG000'}, {'value': '461.6', 'groupId': 'OG001'}, {'value': '391.3', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}, {'value': '691', 'groupId': 'OG001'}, {'value': '686', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5845.0', 'groupId': 'OG000'}, {'value': '6077.6', 'groupId': 'OG001'}, {'value': '6123.8', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5160.6', 'groupId': 'OG000'}, {'value': '5362.7', 'groupId': 'OG001'}, {'value': '5109.5', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '687', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3757.7', 'groupId': 'OG000'}, {'value': '4590.5', 'groupId': 'OG001'}, {'value': '4202.0', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1708.4', 'groupId': 'OG000'}, {'value': '1690.6', 'groupId': 'OG001'}, {'value': '1749.9', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '687', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2364.8', 'groupId': 'OG000'}, {'value': '2509.6', 'groupId': 'OG001'}, {'value': '2050.6', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3880.8', 'groupId': 'OG000'}, {'value': '3522.4', 'groupId': 'OG001'}, {'value': '3381.0', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3384.7', 'groupId': 'OG000'}, {'value': '3774.8', 'groupId': 'OG001'}, {'value': '3498.5', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1866.4', 'groupId': 'OG000'}, {'value': '2017.8', 'groupId': 'OG001'}, {'value': '1993.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '686', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2222.9', 'groupId': 'OG000'}, {'value': '2417.8', 'groupId': 'OG001'}, {'value': '2133.0', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '684', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2617.4', 'groupId': 'OG000'}, {'value': '2761.6', 'groupId': 'OG001'}, {'value': '2676.0', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '690', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7758.1', 'groupId': 'OG000'}, {'value': '7736.9', 'groupId': 'OG001'}, {'value': '7365.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.24', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.25', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.97', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.05', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.23', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.97', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.43', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.02', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.20', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.42', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], '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': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.12', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], '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': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.18', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.23', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.93', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.01', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], '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': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.12', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', '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': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.10', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.34', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.43', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'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': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.31', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.19', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.02', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.10', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.22', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.05', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.07', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.15', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.10', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.24', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.35', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.11', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], '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': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.21', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.16', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.22', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.22', 'pValueComment': 'Identical p-values for the lower and upper bounds.', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'nonInferiorityComment': 'Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.', 'otherAnalysisDescription': 'GMT ratio and 95% CI were estimated from a cLDA model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30', 'description': 'Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.', 'unitOfMeasure': '1/dil', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000'}, {'value': '4.05', 'groupId': 'OG001'}, {'value': '3.83', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000'}, {'value': '0.86', 'groupId': 'OG001'}, {'value': '0.73', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000'}, {'value': '2.18', 'groupId': 'OG001'}, {'value': '1.67', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.81', 'groupId': 'OG000'}, {'value': '4.63', 'groupId': 'OG001'}, {'value': '3.96', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.09', 'groupId': 'OG000'}, {'value': '8.84', 'groupId': 'OG001'}, {'value': '8.16', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.92', 'groupId': 'OG000'}, {'value': '11.46', 'groupId': 'OG001'}, {'value': '10.44', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.71', 'groupId': 'OG000'}, {'value': '7.11', 'groupId': 'OG001'}, {'value': '5.94', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000'}, {'value': '4.44', 'groupId': 'OG001'}, {'value': '4.26', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.82', 'groupId': 'OG000'}, {'value': '11.38', 'groupId': 'OG001'}, {'value': '8.66', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.07', 'groupId': 'OG000'}, {'value': '11.81', 'groupId': 'OG001'}, {'value': '10.66', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.45', 'groupId': 'OG000'}, {'value': '17.34', 'groupId': 'OG001'}, {'value': '15.81', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.78', 'groupId': 'OG000'}, {'value': '11.22', 'groupId': 'OG001'}, {'value': '10.65', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.38', 'groupId': 'OG000'}, {'value': '7.97', 'groupId': 'OG001'}, {'value': '7.44', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.12', 'groupId': 'OG000'}, {'value': '4.41', 'groupId': 'OG001'}, {'value': '3.80', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}, {'value': '688', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.92', 'groupId': 'OG000'}, {'value': '10.88', 'groupId': 'OG001'}, {'value': '9.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.10', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 1: GMC Ratio V114 Lot 1 / V114 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': '0.89', 'ciUpperLimit': '1.17', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 1: GMC Ratio V114 Lot 1 / V114 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': '0.92', 'ciUpperLimit': '1.21', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 1: GMC Ratio V114 Lot 2 / V114 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': '0.85', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.95', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 3: GMC Ratio V114 Lot 1 / V114 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': '1.01', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.13', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 3: GMC Ratio V114 Lot 1 / V114 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': '1.18', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.32', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 3: GMC Ratio V114 Lot 2 / V114 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': '0.82', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.94', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 4: GMC Ratio V114 Lot 1 / V114 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': '0.94', 'ciUpperLimit': '1.23', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 4: GMC Ratio V114 Lot 1 / V114 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': '1.31', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.50', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value for the comparison of the GMT ratio to the upper bound (2.0).', 'otherAnalysisDescription': 'GMC ratio and 95% CI were estimated from a cLDA model.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.95', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 5: GMC Ratio V114 Lot 1 / V114 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': '1.11', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 5: GMC Ratio V114 Lot 1 / V114 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': '1.17', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.35', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 5: GMC Ratio V114 Lot 2 / V114 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': '0.92', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.07', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 6A: GMC Ratio V114 Lot 1 / V114 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': '0.85', 'ciUpperLimit': '1.16', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 6A: GMC Ratio V114 Lot 1 / V114 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': '1.08', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.27', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 6A: GMC Ratio V114 Lot 2 / V114 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': '0.82', 'ciUpperLimit': '1.11', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 6B: GMC Ratio V114 Lot 1 / V114 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': '1.05', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.22', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 6B: GMC Ratio V114 Lot 1 / V114 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': '1.10', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.28', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 6B: GMC Ratio V114 Lot 2 / V114 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': '0.80', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.92', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 7F: GMC Ratio V114 Lot 1 / V114 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': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 7F: GMC Ratio V114 Lot 1 / V114 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': '1.20', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.37', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 7F: GMC Ratio V114 Lot 2 / V114 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': '1.08', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2', 'statisticalMethod': 'l', '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': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 9V: GMC Ratio V114 Lot 1 / V114 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': '1.04', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.19', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 9V: GMC Ratio V114 Lot 2 / V114 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': '0.86', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.00', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 14: GMC Ratio V114 Lot 1 / V114 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': '1.13', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.31', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 14: GMC Ratio V114 Lot 1 / V114 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': '1.31', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.52', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 14: GMC Ratio V114 Lot 2 / V114 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': '1.19', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.36', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 18C: GMC Ratio V114 Lot 1 / V114 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': '1.32', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.51', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 18C: GMC Ratio V114 Lot 1 / V114 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': '1.11', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.27', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 18C: GMC Ratio V114 Lot 2 / V114 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': '0.89', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.02', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 19A: GMC Ratio V114 Lot 1 / V114 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': '0.86', 'ciUpperLimit': '1.11', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 19A: GMC Ratio V114 Lot 1 / V114 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': '1.10', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.25', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 19A: GMC Ratio V114 Lot 2 / V114 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': '0.87', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.00', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 19F: GMC Ratio V114 Lot 1 / V114 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': '0.80', 'ciUpperLimit': '1.05', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 19F: GMC Ratio V114 Lot 1 / V114 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': '0.92', 'ciUpperLimit': '1.21', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 19F: GMC Ratio V114 Lot 2 / V114 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': '0.93', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.07', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 23F: GMC Ratio V114 Lot 1 / V114 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': '0.86', 'ciUpperLimit': '1.15', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 23F: GMC Ratio V114 Lot 1 / V114 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': '1.07', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.24', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 23F: GMC Ratio V114 Lot 2 / V114 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': '0.93', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.08', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 22F: GMC Ratio V114 Lot 1 / V114 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': '1.08', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.26', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 22F: GMC Ratio V114 Lot 1 / V114 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': '1.16', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.35', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 22F: GMC Ratio V114 Lot 2 / V114 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': '0.91', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.06', 'estimateComment': 'Lot 1 divided by Lot 2', 'groupDescription': 'Serotype 33F: GMC Ratio V114 Lot 1 / V114 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': '1.05', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.22', 'estimateComment': 'Lot 1 divided by Lot 3', 'groupDescription': 'Serotype 33F: GMC Ratio V114 Lot 1 / V114 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': '1.15', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.34', 'estimateComment': 'Lot 2 divided by Lot 3', 'groupDescription': 'Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC ratio and 95% CI were estimated from a cLDA model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30', 'description': "The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.", 'unitOfMeasure': 'μg/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2102', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Combined Lots 1,2 and 3', 'description': 'Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000'}, {'value': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000'}, {'value': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2073', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.87', 'groupId': 'OG000'}, {'value': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.14', 'groupId': 'OG000'}, {'value': '4.66', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.38', 'groupId': 'OG000'}, {'value': '7.20', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.92', 'groupId': 'OG000'}, {'value': '7.28', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.19', 'groupId': 'OG000'}, {'value': '7.12', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.30', 'groupId': 'OG000'}, {'value': '4.97', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.89', 'groupId': 'OG000'}, {'value': '9.97', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.08', 'groupId': 'OG000'}, {'value': '9.58', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.18', 'groupId': 'OG000'}, {'value': '16.66', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.52', 'groupId': 'OG000'}, {'value': '10.25', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.58', 'groupId': 'OG000'}, {'value': '6.03', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.10', 'groupId': 'OG000'}, {'value': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2074', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.03', 'groupId': 'OG000'}, {'value': '1.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.91', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '1.39', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.61', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '0.79', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.94', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '0.89', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.07', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '1.16', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.43', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '1.50', 'ciLowerLimit': '1.21', 'ciUpperLimit': '1.86', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '0.87', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.04', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '0.87', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.04', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '0.99', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.20', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '1.26', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.51', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '0.82', 'ciUpperLimit': '1.15', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '1.03', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.23', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '1.26', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.54', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '12.21', 'ciLowerLimit': '10.11', 'ciUpperLimit': '14.74', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™', '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': '9.42', 'ciLowerLimit': '7.96', 'ciUpperLimit': '11.13', 'estimateComment': 'V114 Combined Lots divided by Prevnar 13™', 'groupDescription': 'Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'GMC ratio and 95% CI were estimated from a cLDA model.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30', 'description': "The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,", 'unitOfMeasure': 'μg/mL', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}, {'value': '661', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '18.2'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '18.8'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '17.4'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}, {'value': '657', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7.2'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '8.4'}, {'value': '6.9', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '7.6'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}, {'value': '658', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '19.8'}, {'value': '20.7', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '23.4'}, {'value': '16.5', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '18.7'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '12.8'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '15.1'}, {'value': '11.1', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '12.7'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}, {'value': '611', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '15.5'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '16.0'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '16.5'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '659', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}, {'value': '653', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '38.5'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '36.1'}, {'value': '34.9', 'groupId': 'OG002', 'lowerLimit': '30.2', 'upperLimit': '40.3'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}, {'value': '646', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '13.7'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '16.5'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '14.8'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}, {'value': '641', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '5.3'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '5.3'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '5.6'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}, {'value': '662', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '8.6'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '8.7'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '7.0'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}, {'value': '651', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '18.8'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '16.8'}, {'value': '14.1', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '15.8'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}, {'value': '660', 'groupId': 'OG001'}, {'value': '650', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '11.8'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '12.5'}, {'value': '11.7', 'groupId': 'OG002', 'lowerLimit': '10.3', 'upperLimit': '13.4'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}, {'value': '659', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7.3'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '7.6'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '8.1'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '626', 'groupId': 'OG001'}, {'value': '633', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '19.4'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '20.0'}, {'value': '17.0', 'groupId': 'OG002', 'lowerLimit': '14.8', 'upperLimit': '19.4'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}, {'value': '602', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '33.1'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '38.0'}, {'value': '28.3', 'groupId': 'OG002', 'lowerLimit': '23.4', 'upperLimit': '34.3'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}, {'value': '641', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '9.7'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.9'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '8.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '12.2'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '12.4'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '11.5'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '5.9'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '6.9'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '5.7'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '672', 'groupId': 'OG001'}, {'value': '664', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '9.5'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '11.6'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '8.7'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.0'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '6.0'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '5.2'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '25.3'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '27.1'}, {'value': '22.9', 'groupId': 'OG002', 'lowerLimit': '20.4', 'upperLimit': '25.8'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '26.3'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '27.0'}, {'value': '22.1', 'groupId': 'OG002', 'lowerLimit': '19.7', 'upperLimit': '24.8'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '13.1'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '16.6'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '13.3'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '10.5'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '10.9'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '10.6'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '7.3'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '7.7'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '4.7', 'upperLimit': '5.8'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '23.1'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '19.1'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '14.2', 'upperLimit': '17.9'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '10.0'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '11.7'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '10.5'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '13.7'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '15.4'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '14.5'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '16.1'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '18.1'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '16.6'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '14.4'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '15.1'}, {'value': '11.1', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '12.5'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '10.3'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '10.6'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '8.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': "The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.", 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}, {'value': '661', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '70.9', 'upperLimit': '77.7'}, {'value': '76.8', 'groupId': 'OG001', 'lowerLimit': '73.4', 'upperLimit': '79.9'}, {'value': '77.2', 'groupId': 'OG002', 'lowerLimit': '73.8', 'upperLimit': '80.3'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}, {'value': '657', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '68.3'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '65.2', 'upperLimit': '72.4'}, {'value': '64.8', 'groupId': 'OG002', 'lowerLimit': '61.1', 'upperLimit': '68.5'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}, {'value': '658', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '82.4'}, {'value': '83.6', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '86.3'}, {'value': '79.5', 'groupId': 'OG002', 'lowerLimit': '76.2', 'upperLimit': '82.5'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '67.7', 'upperLimit': '74.7'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '72.7', 'upperLimit': '79.3'}, {'value': '69.5', 'groupId': 'OG002', 'lowerLimit': '65.8', 'upperLimit': '73.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}, {'value': '611', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '75.1', 'upperLimit': '81.7'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '81.0'}, {'value': '76.9', 'groupId': 'OG002', 'lowerLimit': '73.4', 'upperLimit': '80.2'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '659', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}, {'value': '653', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '86.1'}, {'value': '83.6', 'groupId': 'OG001', 'lowerLimit': '80.5', 'upperLimit': '86.3'}, {'value': '84.5', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '87.2'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}, {'value': '646', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '73.0'}, {'value': '71.6', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '75.1'}, {'value': '70.4', 'groupId': 'OG002', 'lowerLimit': '66.7', 'upperLimit': '73.9'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}, {'value': '641', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '57.3'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '47.3', 'upperLimit': '55.1'}, {'value': '53.2', 'groupId': 'OG002', 'lowerLimit': '49.3', 'upperLimit': '57.1'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}, {'value': '662', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '52.9', 'upperLimit': '60.6'}, {'value': '57.6', 'groupId': 'OG001', 'lowerLimit': '53.7', 'upperLimit': '61.4'}, {'value': '52.3', 'groupId': 'OG002', 'lowerLimit': '48.4', 'upperLimit': '56.1'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}, {'value': '651', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '83.1'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '75.7', 'upperLimit': '82.0'}, {'value': '78.3', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '81.4'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}, {'value': '660', 'groupId': 'OG001'}, {'value': '650', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '71.4'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '66.2', 'upperLimit': '73.3'}, {'value': '71.2', 'groupId': 'OG002', 'lowerLimit': '67.6', 'upperLimit': '74.7'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '663', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}, {'value': '659', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '64.5'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '65.6'}, {'value': '63.0', 'groupId': 'OG002', 'lowerLimit': '59.2', 'upperLimit': '66.7'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '626', 'groupId': 'OG001'}, {'value': '633', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '78.7'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '74.8', 'upperLimit': '81.4'}, {'value': '78.2', 'groupId': 'OG002', 'lowerLimit': '74.8', 'upperLimit': '81.4'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}, {'value': '602', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '67.4', 'upperLimit': '74.7'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '69.6', 'upperLimit': '76.9'}, {'value': '72.8', 'groupId': 'OG002', 'lowerLimit': '69.0', 'upperLimit': '76.3'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}, {'value': '641', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '55.6', 'upperLimit': '63.3'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '54.4', 'upperLimit': '62.2'}, {'value': '56.8', 'groupId': 'OG002', 'lowerLimit': '52.8', 'upperLimit': '60.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'OG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '77.1'}, {'value': '75.2', 'groupId': 'OG001', 'lowerLimit': '71.8', 'upperLimit': '78.4'}, {'value': '73.0', 'groupId': 'OG002', 'lowerLimit': '69.4', 'upperLimit': '76.3'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '54.8', 'upperLimit': '62.4'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '65.6'}, {'value': '54.7', 'groupId': 'OG002', 'lowerLimit': '50.8', 'upperLimit': '58.5'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}, {'value': '672', 'groupId': 'OG001'}, {'value': '664', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '72.3'}, {'value': '73.8', 'groupId': 'OG001', 'lowerLimit': '70.3', 'upperLimit': '77.1'}, {'value': '65.7', 'groupId': 'OG002', 'lowerLimit': '61.9', 'upperLimit': '69.3'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '49.5'}, {'value': '52.5', 'groupId': 'OG001', 'lowerLimit': '48.7', 'upperLimit': '56.3'}, {'value': '45.9', 'groupId': 'OG002', 'lowerLimit': '42.1', 'upperLimit': '49.8'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '89.0'}, {'value': '87.2', 'groupId': 'OG001', 'lowerLimit': '84.5', 'upperLimit': '89.7'}, {'value': '83.8', 'groupId': 'OG002', 'lowerLimit': '80.8', 'upperLimit': '86.5'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '89.4'}, {'value': '85.6', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '88.2'}, {'value': '84.2', 'groupId': 'OG002', 'lowerLimit': '81.2', 'upperLimit': '86.9'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '78.5'}, {'value': '78.8', 'groupId': 'OG001', 'lowerLimit': '75.5', 'upperLimit': '81.8'}, {'value': '74.8', 'groupId': 'OG002', 'lowerLimit': '71.3', 'upperLimit': '78.0'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '76.0'}, {'value': '73.0', 'groupId': 'OG001', 'lowerLimit': '69.4', 'upperLimit': '76.3'}, {'value': '71.6', 'groupId': 'OG002', 'lowerLimit': '68.0', 'upperLimit': '75.0'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '58.2'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '61.6'}, {'value': '48.3', 'groupId': 'OG002', 'lowerLimit': '44.5', 'upperLimit': '52.2'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '87.3'}, {'value': '78.6', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '81.7'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '73.3', 'upperLimit': '79.9'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '74.0'}, {'value': '74.2', 'groupId': 'OG001', 'lowerLimit': '70.7', 'upperLimit': '77.5'}, {'value': '71.0', 'groupId': 'OG002', 'lowerLimit': '67.4', 'upperLimit': '74.4'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '74.5', 'upperLimit': '80.9'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '75.8', 'upperLimit': '82.1'}, {'value': '78.6', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '81.7'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '79.2'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '83.6'}, {'value': '76.7', 'groupId': 'OG002', 'lowerLimit': '73.3', 'upperLimit': '79.9'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '78.5'}, {'value': '75.4', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '78.6'}, {'value': '72.1', 'groupId': 'OG002', 'lowerLimit': '68.5', 'upperLimit': '75.5'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '666', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'OG000', 'lowerLimit': '65.8', 'upperLimit': '72.9'}, {'value': '70.9', 'groupId': 'OG001', 'lowerLimit': '67.3', 'upperLimit': '74.3'}, {'value': '66.1', 'groupId': 'OG002', 'lowerLimit': '62.3', 'upperLimit': '69.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': "The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V114 Lot 1', 'description': 'Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'FG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'FG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'FG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '702'}, {'groupId': 'FG001', 'numSubjects': '704'}, {'groupId': 'FG002', 'numSubjects': '701'}, {'groupId': 'FG003', 'numSubjects': '233'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '698'}, {'groupId': 'FG001', 'numSubjects': '704'}, {'groupId': 'FG002', 'numSubjects': '700'}, {'groupId': 'FG003', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '683'}, {'groupId': 'FG001', 'numSubjects': '689'}, {'groupId': 'FG002', 'numSubjects': '683'}, {'groupId': 'FG003', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unable to phone', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Healthy males or females ≥50 years of age without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'BG000'}, {'value': '704', 'groupId': 'BG001'}, {'value': '701', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}, {'value': '2340', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'V114 Lot 1', 'description': 'Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'BG001', 'title': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'BG002', 'title': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)'}, {'id': 'BG003', 'title': 'Prevnar13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '7.4', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '8.0', 'groupId': 'BG003'}, {'value': '64.4', 'spread': '7.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '387', 'groupId': 'BG000'}, {'value': '422', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}, {'value': '1346', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '994', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '464', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '560', 'groupId': 'BG000'}, {'value': '540', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '1848', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '644', 'groupId': 'BG000'}, {'value': '621', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}, {'value': '2096', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-09', 'size': 801277, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-16T13:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2019-05-13', 'resultsFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2019-05-13', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-16', 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots', 'timeFrame': 'Up to Day 5', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.'}, {'measure': 'Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'timeFrame': 'Up to Day 5', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.'}, {'measure': 'Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots', 'timeFrame': 'Up to Day 14', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.'}, {'measure': 'Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'timeFrame': 'Up to Day 14', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots', 'timeFrame': 'Up to Month 6', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'timeFrame': 'Up to Month 6', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.'}, {'measure': 'Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots', 'timeFrame': 'Day 30', 'description': 'Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots', 'timeFrame': 'Day 30', 'description': "The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots."}, {'measure': 'Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™', 'timeFrame': 'Day 30', 'description': "The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,"}, {'measure': 'Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.'}, {'measure': 'GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': "The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed."}, {'measure': 'Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.'}, {'measure': 'Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': "The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections', 'Pneumonia, Pneumococcal']}, 'referencesModule': {'references': [{'pmid': '35039194', 'type': 'DERIVED', 'citation': 'Simon JK, Staerke NB, Hemming-Harlo M, Layle S, Dagan R, Shekar T, Pedley A, Jumes P, Tamms G, Sterling T, Musey L, Buchwald UK; V114-020 PNEU-TRUE study group. Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged >/=50 years: A randomized phase 3 trial (PNEU-TRUE). Vaccine. 2022 Feb 23;40(9):1342-1351. doi: 10.1016/j.vaccine.2021.12.067. Epub 2022 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.\n\nExclusion Criteria:\n\n* History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1).\n* Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.\n* Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.\n* Coagulation disorder contraindicating intramuscular vaccinations.\n* Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \\[≥38.0°C\\] or axillary or temporal temperature ≥99.4°F \\[≥37.4°C\\]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.\n* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1).\n* Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.\n* Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.\n* Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue \\[e.g., bursa, tendon steroid injections\\], and inhaled/nebulized steroids are permitted).\n* Is receiving immunosuppressive therapy, including chemotherapeutic agents 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 within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)\n* Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine. If this exclusion criterion is met, then Day 1 Visit may be rescheduled for a time when criterion is not met.\n* Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.\n* Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.\n* In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities.\n* History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study.\n* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study."}, 'identificationModule': {'nctId': 'NCT03950856', 'acronym': 'PNEU-TRUE', 'briefTitle': 'Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)', 'orgStudyIdInfo': {'id': 'V114-020'}, 'secondaryIdInfos': [{'id': 'V114-020', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2018-004266-33', 'type': 'OTHER', 'domain': 'EudraCT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V114 Lot 1', 'description': 'Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)', 'interventionNames': ['Drug: V114']}, {'type': 'EXPERIMENTAL', 'label': 'V114 Lot 2', 'description': 'Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)', 'interventionNames': ['Drug: V114']}, {'type': 'EXPERIMENTAL', 'label': 'V114 Lot 3', 'description': 'Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)', 'interventionNames': ['Drug: V114']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13™', 'description': 'Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)', 'interventionNames': ['Drug: Prevnar 13™']}], 'interventions': [{'name': 'V114', 'type': 'DRUG', 'description': '15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.', 'armGroupLabels': ['V114 Lot 1', 'V114 Lot 2', 'V114 Lot 3']}, {'name': 'Prevnar 13™', 'type': 'DRUG', 'description': '13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.', 'armGroupLabels': ['Prevnar 13™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc. 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