Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT03547167
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2018-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).', 'description': 'The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).', 'otherNumAtRisk': 1134, 'deathsNumAtRisk': 1134, 'otherNumAffected': 934, 'seriousNumAtRisk': 1134, 'deathsNumAffected': 4, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).', 'otherNumAtRisk': 378, 'deathsNumAtRisk': 378, 'otherNumAffected': 298, 'seriousNumAtRisk': 378, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'V114 (Post-PNEUMOVAX™23)', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).', 'otherNumAtRisk': 1036, 'deathsNumAtRisk': 1036, 'otherNumAffected': 771, 'seriousNumAtRisk': 1036, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Prevnar 13™ (Post-PNEUMOVAX™23)', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).', 'otherNumAtRisk': 345, 'deathsNumAtRisk': 345, 'otherNumAffected': 258, 'seriousNumAtRisk': 345, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 510, 'numAffected': 389}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 186, 'numAffected': 139}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 366, 'numAffected': 312}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 139, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 180, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 57, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 237, 'numAffected': 235}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 91, 'numAffected': 88}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 931, 'numAffected': 865}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 292, 'numAffected': 260}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 762, 'numAffected': 714}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 252, 'numAffected': 231}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 257, 'numAffected': 251}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 84, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 307, 'numAffected': 305}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 113, 'numAffected': 113}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 180, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 63, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 130, 'numAffected': 124}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 47, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 377, 'numAffected': 327}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 113, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 260, 'numAffected': 250}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 99, 'numAffected': 88}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 425, 'numAffected': 300}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 122, 'numAffected': 94}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 274, 'numAffected': 220}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 93, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetes insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematoma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 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'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 378, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1036, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1134', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Injection site redness/erythema', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '17.3'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '17.9'}]}]}, {'title': 'Injection site tenderness/pain', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '78.3'}, {'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '63.8', 'upperLimit': '73.4'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '24.2'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '26.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after Vaccination 1', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1134', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Joint pain/arthralgia', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '14.8'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '15.3'}]}]}, {'title': 'Tiredness/fatigue', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '37.1'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '41.9'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '29.1'}, {'value': '24.9', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '29.5'}]}]}, {'title': 'Muscle pain/myalgia', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '31.6'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '31.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after Vaccination 1', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1134', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 6 (before Vaccination 2)', 'description': 'A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1133', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Serotype 1 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '268.6', 'groupId': 'OG000', 'lowerLimit': '243.7', 'upperLimit': '296.0'}, {'value': '267.2', 'groupId': 'OG001', 'lowerLimit': '220.4', 'upperLimit': '323.9'}]}]}, {'title': 'Serotype 3 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1004', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '199.3', 'groupId': 'OG000', 'lowerLimit': '184.6', 'upperLimit': '215.2'}, {'value': '150.6', 'groupId': 'OG001', 'lowerLimit': '130.6', 'upperLimit': '173.8'}]}]}, {'title': 'Serotype 4 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1016', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1416.0', 'groupId': 'OG000', 'lowerLimit': '1308.9', 'upperLimit': '1531.8'}, {'value': '2576.1', 'groupId': 'OG001', 'lowerLimit': '2278.0', 'upperLimit': '2913.2'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1018', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '564.8', 'groupId': 'OG000', 'lowerLimit': '512.7', 'upperLimit': '622.2'}, {'value': '731.1', 'groupId': 'OG001', 'lowerLimit': '613.6', 'upperLimit': '871.0'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1006', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12928.8', 'groupId': 'OG000', 'lowerLimit': '11923.4', 'upperLimit': '14019.0'}, {'value': '11282.4', 'groupId': 'OG001', 'lowerLimit': '9718.8', 'upperLimit': '13097.5'}]}]}, {'title': 'Serotype 6B (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1014', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10336.9', 'groupId': 'OG000', 'lowerLimit': '9649.4', 'upperLimit': '11073.4'}, {'value': '6995.7', 'groupId': 'OG001', 'lowerLimit': '6024.7', 'upperLimit': '8123.2'}]}]}, {'title': 'Serotype 7F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5756.4', 'groupId': 'OG000', 'lowerLimit': '5410.4', 'upperLimit': '6124.6'}, {'value': '7588.9', 'groupId': 'OG001', 'lowerLimit': '6775.3', 'upperLimit': '8500.2'}]}]}, {'title': 'Serotype 9V (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1015', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3355.1', 'groupId': 'OG000', 'lowerLimit': '3135.4', 'upperLimit': '3590.1'}, {'value': '3983.7', 'groupId': 'OG001', 'lowerLimit': '3557.8', 'upperLimit': '4460.7'}]}]}, {'title': 'Serotype 14 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1016', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5228.9', 'groupId': 'OG000', 'lowerLimit': '4847.6', 'upperLimit': '5640.2'}, {'value': '5889.8', 'groupId': 'OG001', 'lowerLimit': '5218.2', 'upperLimit': '6647.8'}]}]}, {'title': 'Serotype 18C (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1014', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5709.0', 'groupId': 'OG000', 'lowerLimit': '5331.1', 'upperLimit': '6113.6'}, {'value': '3063.2', 'groupId': 'OG001', 'lowerLimit': '2699.8', 'upperLimit': '3475.5'}]}]}, {'title': 'Serotype 19A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1015', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5369.9', 'groupId': 'OG000', 'lowerLimit': '5017.7', 'upperLimit': '5746.8'}, {'value': '5888.0', 'groupId': 'OG001', 'lowerLimit': '5228.2', 'upperLimit': '6631.0'}]}]}, {'title': 'Serotype 19F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1018', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3266.3', 'groupId': 'OG000', 'lowerLimit': '3064.4', 'upperLimit': '3481.4'}, {'value': '3272.7', 'groupId': 'OG001', 'lowerLimit': '2948.2', 'upperLimit': '3632.9'}]}]}, {'title': 'Serotype 23F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1016', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4853.5', 'groupId': 'OG000', 'lowerLimit': '4469.8', 'upperLimit': '5270.2'}, {'value': '3887.3', 'groupId': 'OG001', 'lowerLimit': '3335.8', 'upperLimit': '4530.0'}]}]}, {'title': 'Serotype 22F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1005', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3926.5', 'groupId': 'OG000', 'lowerLimit': '3645.9', 'upperLimit': '4228.7'}, {'value': '291.6', 'groupId': 'OG001', 'lowerLimit': '221.8', 'upperLimit': '383.6'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1014', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11627.8', 'groupId': 'OG000', 'lowerLimit': '10824.6', 'upperLimit': '12490.7'}, {'value': '2180.6', 'groupId': 'OG001', 'lowerLimit': '1828.7', 'upperLimit': '2600.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30', 'description': 'The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Injection site redness/erythema', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '25.3'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '30.5'}]}]}, {'title': 'Injection site tenderness/pain', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '65.9', 'upperLimit': '71.6'}, {'value': '67.0', 'groupId': 'OG001', 'lowerLimit': '61.7', 'upperLimit': '71.9'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '32.3'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '37.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after Vaccination 2 (Month 6)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Joint pain/arthralgia', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '14.1'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '14.8'}]}]}, {'title': 'Tiredness/fatigue', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '33.0'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '35.9'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '23.9'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '25.9'}]}]}, {'title': 'Muscle pain/myalgia', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '26.9'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '30.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after Vaccination 2 (Month 6)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 6 (before Vaccination 2) to Month 7', 'description': 'A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1133', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Serotype 1 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1020', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.56', 'groupId': 'OG000', 'lowerLimit': '3.29', 'upperLimit': '3.85'}, {'value': '4.59', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '5.26'}]}]}, {'title': 'Serotype 3 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1017', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '0.83'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.71'}]}]}, {'title': 'Serotype 4 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1015', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.66'}, {'value': '2.71', 'groupId': 'OG001', 'lowerLimit': '2.34', 'upperLimit': '3.13'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1020', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.43', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '3.75'}, {'value': '4.48', 'groupId': 'OG001', 'lowerLimit': '3.77', 'upperLimit': '5.32'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1020', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.84', 'groupId': 'OG000', 'lowerLimit': '10.71', 'upperLimit': '13.10'}, {'value': '10.87', 'groupId': 'OG001', 'lowerLimit': '9.06', 'upperLimit': '13.05'}]}]}, {'title': 'Serotype 6B (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1020', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.90', 'groupId': 'OG000', 'lowerLimit': '16.21', 'upperLimit': '19.76'}, 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'denoms': [{'units': 'Participants', 'counts': [{'value': '885', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '16.3'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.6'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '979', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '5.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. 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'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '8.6'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '18.4'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1007', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.7'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '6.0'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1007', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '38.8'}, {'value': '31.3', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '36.6'}]}]}, {'title': 'Serotype 6B (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1006', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '37.1', 'upperLimit': '44.2'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '24.2', 'upperLimit': '32.4'}]}]}, {'title': 'Serotype 7F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1007', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '13.2'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '19.3'}]}]}, {'title': 'Serotype 9V (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1006', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '11.4'}, 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The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer of Serotype-specific OPA at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1133', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 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[{'units': 'Participants', 'counts': [{'value': '836', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4336.2', 'groupId': 'OG000', 'lowerLimit': '4038.6', 'upperLimit': '4655.6'}, {'value': '4286.4', 'groupId': 'OG001', 'lowerLimit': '3838.6', 'upperLimit': '4786.4'}]}]}, {'title': 'Serotype 19F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3198.6', 'groupId': 'OG000', 'lowerLimit': '3011.0', 'upperLimit': '3397.8'}, {'value': '3085.4', 'groupId': 'OG001', 'lowerLimit': '2770.7', 'upperLimit': '3435.9'}]}]}, {'title': 'Serotype 23F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '839', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3057.3', 'groupId': 'OG000', 'lowerLimit': '2823.0', 'upperLimit': '3311.0'}, 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'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Serotype 1 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '2.71', 'upperLimit': '3.12'}, {'value': '3.42', 'groupId': 'OG001', 'lowerLimit': '3.02', 'upperLimit': '3.87'}]}]}, {'title': 'Serotype 3 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.71'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '0.76'}]}]}, {'title': 'Serotype 4 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '1.44'}, {'value': '1.77', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '2.02'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000', 'lowerLimit': '3.17', 'upperLimit': '3.75'}, {'value': '3.92', 'groupId': 'OG001', 'lowerLimit': '3.37', 'upperLimit': '4.56'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '3.84', 'upperLimit': '4.69'}, {'value': '4.88', 'groupId': 'OG001', 'lowerLimit': 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'lowerLimit': '2.96', 'upperLimit': '3.43'}, {'value': '3.61', 'groupId': 'OG001', 'lowerLimit': '3.17', 'upperLimit': '4.12'}]}]}, {'title': 'Serotype 14 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.28', 'groupId': 'OG000', 'lowerLimit': '13.13', 'upperLimit': '15.53'}, {'value': '14.59', 'groupId': 'OG001', 'lowerLimit': '12.64', 'upperLimit': '16.85'}]}]}, {'title': 'Serotype 18C (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.50', 'groupId': 'OG000', 'lowerLimit': '5.07', 'upperLimit': '5.98'}, {'value': '4.24', 'groupId': 'OG001', 'lowerLimit': '3.71', 'upperLimit': '4.84'}]}]}, {'title': 'Serotype 19A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': 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(Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.85', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '5.23'}, {'value': '4.76', 'groupId': 'OG001', 'lowerLimit': '4.01', 'upperLimit': '5.65'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.98', 'groupId': 'OG000', 'lowerLimit': '5.50', 'upperLimit': '6.50'}, {'value': '8.66', 'groupId': 'OG001', 'lowerLimit': '7.31', 'upperLimit': '10.26'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 7', 'description': 'The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.'}, {'type': 'SECONDARY', 'title': 'GMFR in Serotype-specific OPA Day 1 to Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1133', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Serotype 1 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '24.8'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '20.5'}]}]}, {'title': 'Serotype 3 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '820', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.6'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '7.3'}]}]}, {'title': 'Serotype 4 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '820', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '23.9'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '30.3'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '831', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '19.3'}, {'value': '18.3', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '21.1'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '10.5'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '13.0'}]}]}, {'title': 'Serotype 6B (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '802', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '18.7'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '19.2'}]}]}, {'title': 'Serotype 7F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '8.6'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '9.9'}]}]}, {'title': 'Serotype 9V (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '810', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '4.9'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.7'}]}]}, {'title': 'Serotype 14 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '809', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '10.3'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '9.7'}]}]}, {'title': 'Serotype 18C (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '805', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '12.2'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '10.5'}]}]}, {'title': 'Serotype 19A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '806', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '10.6'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '11.6'}]}]}, {'title': 'Serotype 19F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '818', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '7.6'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '8.3'}]}]}, {'title': 'Serotype 23F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '780', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '15.7'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '15.4'}]}]}, {'title': 'Serotype 22F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '14.3'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '22.6'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '810', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '5.7'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '8.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and Month 7', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.'}, {'type': 'SECONDARY', 'title': 'GMFR in Serotype-specific IgG Day 1 to Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1133', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Serotype 1 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '10.8'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '12.8'}]}]}, {'title': 'Serotype 3 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.7'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '4.2'}]}]}, {'title': 'Serotype 4 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '830', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '7.6'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '12.0'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.6'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.2'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '832', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '13.4'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '16.1'}]}]}, {'title': 'Serotype 6B (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '832', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '16.6'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '17.0'}]}]}, {'title': 'Serotype 7F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '9.3'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '11.3'}]}]}, {'title': 'Serotype 9V (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '8.1'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.5'}]}]}, {'title': 'Serotype 14 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '11.3'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '11.8'}]}]}, {'title': 'Serotype 18C (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '12.4'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '10.4'}]}]}, {'title': 'Serotype 19A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '6.9'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '8.5'}]}]}, {'title': 'Serotype 19F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '9.7'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '11.2'}]}]}, {'title': 'Serotype 23F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '11.7'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '11.7'}]}]}, {'title': 'Serotype 22F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '9.7'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '10.7'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '6.9'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '11.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Baseline) and Month 7', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1133', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114', 'description': 'Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'OG001', 'title': 'Prevnar 13™', 'description': 'Participants received a single 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{'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '81.6', 'upperLimit': '86.7'}, {'value': '86.4', 'groupId': 'OG001', 'lowerLimit': '81.8', 'upperLimit': '90.3'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '831', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '89.0'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '90.8'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '70.2', 'upperLimit': '76.6'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '74.6', 'upperLimit': '84.9'}]}]}, {'title': 'Serotype 6B 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'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '14.6'}]}]}, {'title': 'Serotype 14 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '841', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '20.6'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '12.5'}]}]}, {'title': 'Serotype 18C (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '839', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '7.1'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '19.0'}]}]}, {'title': 'Serotype 19A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '830', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '18.6'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '16.4'}]}]}, {'title': 'Serotype 19F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '20.4'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '17.4'}]}]}, {'title': 'Serotype 23F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '837', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '11.4'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '15.7'}]}]}, {'title': 'Serotype 22F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '19.4'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '46.2', 'upperLimit': '58.9'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '834', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '18.5'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '56.6', 'upperLimit': '68.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 (Baseline before Vaccination 2) and Month 7', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. 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'title': 'Prevnar 13™', 'description': 'Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}], 'classes': [{'title': 'Serotype 1 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '19.0'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '12.0'}]}]}, {'title': 'Serotype 3 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '8.2'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '18.4'}]}]}, {'title': 'Serotype 4 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '840', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '17.8'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '11.2'}]}]}, {'title': 'Serotype 5 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '14.5'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '9.1'}]}]}, {'title': 'Serotype 6A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '3.1'}]}]}, {'title': 'Serotype 6B (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '5.5'}]}]}, {'title': 'Serotype 7F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '10.5'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '7.3'}]}]}, {'title': 'Serotype 9V (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '841', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '8.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 14 (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '12.1'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 18C (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.5'}]}]}, {'title': 'Serotype 19A (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.9'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '7.3'}]}]}, {'title': 'Serotype 19F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '10.1'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '9.9'}]}]}, {'title': 'Serotype 23F (Shared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.2'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '3.1'}]}]}, {'title': 'Serotype 22F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '12.4'}, {'value': '64.9', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '70.5'}]}]}, {'title': 'Serotype 33F (Unique to V114)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '9.5'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '70.5', 'upperLimit': '80.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 (Baseline before Vaccination 2) and Month 7', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. 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2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1135'}, {'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'Vaccination 1 - (V114 or Prevnar 13™, Day 1)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1133'}, {'groupId': 'FG001', 'numSubjects': '379'}]}, {'type': 'Vaccination 2 - (PNEUMOVAX™23, Month 6)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1035'}, {'groupId': 'FG001', 'numSubjects': '346'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1038'}, {'groupId': 'FG001', 'numSubjects': '350'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1135', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '1515', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V114', 'description': 'Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'BG001', 'title': 'Prevnar 13™', 'description': 'Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '581', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '782', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '554', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '984', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '1322', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '445', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '593', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '582', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '774', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study vaccination.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-31', 'size': 889298, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-14T11:04', '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': 1515}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2018-05-24', 'resultsFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-21', 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™', 'timeFrame': 'Up to 5 days after Vaccination 1', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™', 'timeFrame': 'Up to 14 days after Vaccination 1', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™', 'timeFrame': 'Up to Month 6 (before Vaccination 2)', 'description': 'A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™', 'timeFrame': 'Day 30', 'description': 'The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23', 'timeFrame': 'Up to 5 days after Vaccination 2 (Month 6)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.'}, {'measure': 'Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23', 'timeFrame': 'Up to 14 days after Vaccination 2 (Month 6)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23', 'timeFrame': 'From Month 6 (before Vaccination 2) to Month 7', 'description': 'A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.'}, {'measure': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30', 'timeFrame': 'Day 30', 'description': 'The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.'}, {'measure': 'GMFR in Serotype-specific IgG Day 1 to Day 30', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30', 'timeFrame': 'Day 1 (Baseline) and Day 30', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.'}, {'measure': 'Geometric Mean Titer of Serotype-specific OPA at Month 7', 'timeFrame': 'Month 7', 'description': 'The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'Geometric Mean Concentration of Serotype-specific IgG at Month 7', 'timeFrame': 'Month 7', 'description': 'The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.'}, {'measure': 'GMFR in Serotype-specific OPA Day 1 to Month 7', 'timeFrame': 'Day 1 (Baseline) and Month 7', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.'}, {'measure': 'GMFR in Serotype-specific IgG Day 1 to Month 7', 'timeFrame': 'Day 1 (Baseline) and Month 7', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7', 'timeFrame': 'Day 1 (Baseline) and Month 7', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7', 'timeFrame': 'Day 1 (Baseline) and Month 7', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.'}, {'measure': 'GMFR in Serotype-specific OPA Month 6 to Month 7', 'timeFrame': 'Month 6 (Baseline before Vaccination 2) and Month 7', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.'}, {'measure': 'GMFR in Serotype-specific IgG Month 6 to Month 7', 'timeFrame': 'Month 6 (Baseline before Vaccination 2) and Month 7', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7', 'timeFrame': 'Month 6 (Baseline before Vaccination 2) and Month 7', 'description': 'Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.'}, {'measure': 'Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7', 'timeFrame': 'Month 6 (Baseline before Vaccination 2) and Month 7', 'description': 'IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '35146039', 'type': 'DERIVED', 'citation': 'Hammitt LL, Quinn D, Janczewska E, Pasquel FJ, Tytus R, Rajender Reddy K, Abarca K, Khaertynova IM, Dagan R, McCauley J, Cheon K, Pedley A, Sterling T, Tamms G, Musey L, Buchwald UK. Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY). Open Forum Infect Dis. 2021 Dec 18;9(3):ofab605. doi: 10.1093/ofid/ofab605. eCollection 2022 Mar.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with ≥1 of the following risk conditions for pneumococcal disease:\n\n 1. Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) \\<10%\n 2. Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)\n 3. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3\n 4. Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy\n 5. Confirmed diagnosis of chronic heart disease (New York Heart Association \\[NYHA\\] heart failure Class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease.\n 6. Current smoker\n* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine.\n\nExclusion Criteria:\n\n* History of active hepatitis within the prior 3 months\n* History of diabetic ketoacidosis, or \\>1 episodes of severe, symptomatic hypoglycemia within the prior 3 months\n* Myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months\n* History of severe pulmonary hypertension or history of Eisenmenger syndrome\n* History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within the prior 3 years\n* Known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine\n* Known or suspected impairment of immunological function (including human immunodeficiency virus (HIV) infection or autoimmune disease)\n* History of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n* History of Stage 4 or 5 Chronic Kidney Disease or nephrotic syndrome\n* History of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months\n* History of coagulation disorder contraindicating intramuscular vaccination\n* History of hospitalization within the prior 3 months\n* Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study.\n* Expected survival for less than 1 year according to the investigator's judgment.\n* Female participant: positive urine or serum pregnancy test\n* Prior administration of any pneumococcal vaccine\n* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed within the prior 30 days\n* Received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination\n* Receiving immunosuppressive or immunomodulatory therapy with a biological agent\n* Received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine\n* 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\n* Received a blood transfusion or blood products within the prior 6 months\n* Receiving chronic home oxygen therapy\n* Participated in another clinical study of an investigational product within the prior 2 months\n* Current user of recreational or illicit drugs or history of drug abuse or dependence\n* Diabetes mellitus with HgA1c ≥10%\n* Chronic liver disease with Child-Pugh Class B or C cirrhosis\n* Chronic lung disease with Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage 4 or severe persistent asthma\n* Chronic heart disease with NYHA heart failure Class 4."}, 'identificationModule': {'nctId': 'NCT03547167', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)', 'orgStudyIdInfo': {'id': 'V114-017'}, 'secondaryIdInfos': [{'id': '2017-004915-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'V114-017', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V114', 'description': 'Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)', 'interventionNames': ['Biological: V114', 'Biological: PNEUMOVAX™23']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13™', 'description': 'Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)', 'interventionNames': ['Biological: Prevnar 13™', 'Biological: PNEUMOVAX™23']}], 'interventions': [{'name': 'V114', 'type': 'BIOLOGICAL', 'description': '15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose', 'armGroupLabels': ['V114']}, {'name': 'Prevnar 13™', 'type': 'BIOLOGICAL', 'otherNames': ['PCV13'], 'description': '13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose', 'armGroupLabels': ['Prevnar 13™']}, {'name': 'PNEUMOVAX™23', 'type': 'BIOLOGICAL', 'otherNames': ['PPV23'], 'description': '23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose', 'armGroupLabels': ['Prevnar 13™', 'V114']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86503', 'city': 'Chinle', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chinle Comprehensive Health Care Facility ( Site 0001)', 'geoPoint': {'lat': 36.15445, 'lon': -109.55261}}, {'zip': '86504', 'city': 'Fort Defiance', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fort Defiance Center for American Indian Health ( Site 0002)', 'geoPoint': {'lat': 35.74446, 'lon': -109.07648}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates, PA ( Site 0043)', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Central Phoenix Medical Clinic, LLC ( Site 0031)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85941', 'city': 'Whiteriver', 'state': 'Arizona', 'country': 'United States', 'facility': 'Whiteriver Center for American Indian Health ( Site 0005)', 'geoPoint': {'lat': 33.83699, 'lon': -109.96427}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Inland Empire Clinical Trials, LLC ( Site 0052)', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '33189', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Top Medical Research, Inc ( Site 0033)', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc ( Site 0054)', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research ( Site 0008)', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute, P.A. 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