Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-03-05 @ 4:55 PM
Study NCT ID:
NCT03885934
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2019-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
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 any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.', 'description': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'V114 (7-11 Months)', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 44, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Prevnar (7-11 Months)', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 47, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'V114 (12-23 Months)', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 46, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Prevnar (12-23 Months)', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 36, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'V114 (2-17 Years)', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 125, 'seriousNumAtRisk': 177, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Prevnar (2-17 Years)', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 125, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 36, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 39, 'numAffected': 37}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 43, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 111, 'numAffected': 97}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 106, 'numAffected': 99}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 29, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 42, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 38, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 46, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 32, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 33, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 39, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 41, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 33, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chikungunya virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.47', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '2.92'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '4.50'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '2.30', 'upperLimit': '3.05'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '1.40', 'upperLimit': '2.08'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.21', 'groupId': 'OG000', 'lowerLimit': '1.82', 'upperLimit': '2.68'}, {'value': '3.85', 'groupId': 'OG001', 'lowerLimit': '3.12', 'upperLimit': '4.76'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '4.63'}, {'value': '4.56', 'groupId': 'OG001', 'lowerLimit': '3.58', 'upperLimit': '5.80'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '2.91'}, {'value': '4.30', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '5.65'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.03', 'groupId': 'OG000', 'lowerLimit': '2.41', 'upperLimit': '3.82'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '5.36'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.16', 'groupId': 'OG000', 'lowerLimit': '4.27', 'upperLimit': '6.23'}, {'value': '6.42', 'groupId': 'OG001', 'lowerLimit': '5.25', 'upperLimit': '7.85'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.61', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '3.26'}, {'value': '3.59', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '4.51'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.62', 'groupId': 'OG000', 'lowerLimit': '7.94', 'upperLimit': '11.67'}, {'value': '13.07', 'groupId': 'OG001', 'lowerLimit': '10.40', 'upperLimit': '16.42'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000', 'lowerLimit': '2.80', 'upperLimit': '4.24'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '2.75', 'upperLimit': '4.45'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.59', 'groupId': 'OG000', 'lowerLimit': '3.95', 'upperLimit': '5.33'}, {'value': '5.81', 'groupId': 'OG001', 'lowerLimit': '4.92', 'upperLimit': '6.85'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.49', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '4.15'}, {'value': '4.83', 'groupId': 'OG001', 'lowerLimit': '4.03', 'upperLimit': '5.79'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '3.39'}, {'value': '2.79', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '3.69'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.04', 'groupId': 'OG000', 'lowerLimit': '7.48', 'upperLimit': '10.93'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.19'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.37', 'groupId': 'OG000', 'lowerLimit': '2.78', 'upperLimit': '4.10'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.16'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 days post last vaccination', 'description': 'The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}, {'type': 'PRIMARY', 'title': 'GMC of Serotype-specific IgG - Schedule B: 12-23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.83', 'groupId': 'OG000', 'lowerLimit': '3.07', 'upperLimit': '4.77'}, {'value': '4.20', 'groupId': 'OG001', 'lowerLimit': '3.30', 'upperLimit': '5.34'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '2.44', 'upperLimit': '3.58'}, {'value': '1.68', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '2.20'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.46', 'groupId': 'OG000', 'lowerLimit': '2.67', 'upperLimit': '4.50'}, {'value': '4.89', 'groupId': 'OG001', 'lowerLimit': '3.76', 'upperLimit': '6.36'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.39', 'groupId': 'OG000', 'lowerLimit': '2.65', 'upperLimit': '4.34'}, {'value': '3.12', 'groupId': 'OG001', 'lowerLimit': '2.52', 'upperLimit': '3.88'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.05', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '3.23'}, {'value': '3.73', 'groupId': 'OG001', 'lowerLimit': '2.64', 'upperLimit': '5.29'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.69', 'groupId': 'OG000', 'lowerLimit': '1.70', 'upperLimit': '4.25'}, {'value': '2.87', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '4.30'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.80', 'groupId': 'OG000', 'lowerLimit': '3.63', 'upperLimit': '6.34'}, {'value': '5.42', 'groupId': 'OG001', 'lowerLimit': '4.30', 'upperLimit': '6.82'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '3.11'}, {'value': '2.89', 'groupId': 'OG001', 'lowerLimit': '2.21', 'upperLimit': '3.78'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.23', 'groupId': 'OG000', 'lowerLimit': '6.19', 'upperLimit': '10.94'}, {'value': '8.30', 'groupId': 'OG001', 'lowerLimit': '6.56', 'upperLimit': '10.51'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '6.52'}, {'value': '3.68', 'groupId': 'OG001', 'lowerLimit': '2.85', 'upperLimit': '4.75'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.74', 'groupId': 'OG000', 'lowerLimit': '5.29', 'upperLimit': '8.60'}, {'value': '5.87', 'groupId': 'OG001', 'lowerLimit': '4.85', 'upperLimit': '7.11'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.90', 'groupId': 'OG000', 'lowerLimit': '4.69', 'upperLimit': '7.43'}, {'value': '5.92', 'groupId': 'OG001', 'lowerLimit': '4.93', 'upperLimit': '7.11'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000', 'lowerLimit': '1.99', 'upperLimit': '4.07'}, {'value': '2.18', 'groupId': 'OG001', 'lowerLimit': '1.54', 'upperLimit': '3.07'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.90', 'groupId': 'OG000', 'lowerLimit': '12.16', 'upperLimit': '20.78'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.16'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.17', 'groupId': 'OG000', 'lowerLimit': '3.96', 'upperLimit': '6.74'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 days post last vaccination', 'description': 'The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}, {'type': 'PRIMARY', 'title': 'GMC of Serotype-specific IgG - Schedule C: 2-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.60', 'upperLimit': '3.46'}, {'value': '3.99', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '4.58'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '1.58'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '1.21'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '2.96'}, {'value': '5.22', 'groupId': 'OG001', 'lowerLimit': '4.52', 'upperLimit': '6.03'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.43', 'groupId': 'OG000', 'lowerLimit': '2.89', 'upperLimit': '4.07'}, {'value': '4.24', 'groupId': 'OG001', 'lowerLimit': '3.46', 'upperLimit': '5.20'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.03', 'groupId': 'OG000', 'lowerLimit': '7.07', 'upperLimit': '11.53'}, {'value': '8.81', 'groupId': 'OG001', 'lowerLimit': '6.96', 'upperLimit': '11.14'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.55', 'groupId': 'OG000', 'lowerLimit': '10.52', 'upperLimit': '17.46'}, {'value': '10.51', 'groupId': 'OG001', 'lowerLimit': '8.01', 'upperLimit': '13.78'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.03', 'groupId': 'OG000', 'lowerLimit': '3.46', 'upperLimit': '4.70'}, {'value': '4.63', 'groupId': 'OG001', 'lowerLimit': '3.92', 'upperLimit': '5.46'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.60', 'groupId': 'OG000', 'lowerLimit': '3.06', 'upperLimit': '4.24'}, {'value': '4.35', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '5.20'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.21', 'groupId': 'OG000', 'lowerLimit': '7.11', 'upperLimit': '11.92'}, {'value': '8.04', 'groupId': 'OG001', 'lowerLimit': '6.24', 'upperLimit': '10.36'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.16', 'groupId': 'OG000', 'lowerLimit': '6.03', 'upperLimit': '8.52'}, {'value': '4.46', 'groupId': 'OG001', 'lowerLimit': '3.76', 'upperLimit': '5.30'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.99', 'groupId': 'OG000', 'lowerLimit': '9.12', 'upperLimit': '13.26'}, {'value': '14.90', 'groupId': 'OG001', 'lowerLimit': '12.23', 'upperLimit': '18.16'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.95', 'groupId': 'OG000', 'lowerLimit': '7.45', 'upperLimit': '10.76'}, {'value': '12.28', 'groupId': 'OG001', 'lowerLimit': '10.07', 'upperLimit': '14.97'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.36', 'groupId': 'OG000', 'lowerLimit': '4.41', 'upperLimit': '6.50'}, {'value': '5.12', 'groupId': 'OG001', 'lowerLimit': '4.12', 'upperLimit': '6.37'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.99', 'groupId': 'OG000', 'lowerLimit': '12.73', 'upperLimit': '17.66'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.38'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.89', 'groupId': 'OG000', 'lowerLimit': '4.12', 'upperLimit': '5.80'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.32'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 days post vaccination', 'description': 'The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}], 'classes': [{'title': 'Redness/Erythema', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '40.8'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '47.3'}]}]}, {'title': 'Hardness/Induration', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '28.7'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '25.0'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '30.5'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '17.3'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '30.5'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '26.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}], 'classes': [{'title': 'Redness/Erythema', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '33.2'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '34.0'}]}]}, {'title': 'Hardness/Induration', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '17.8'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '19.3'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '47.0'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '35.7'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '25.8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '23.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}], 'classes': [{'title': 'Redness/Erythema', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '25.8'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '27.9'}]}]}, {'title': 'Hardness/Induration', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '11.5'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '21.0'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '62.3'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '48.9', 'upperLimit': '64.0'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '27.6'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '31.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}], 'classes': [{'title': 'Appetite lost/Decreased appetite', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '26.9'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '30.5'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '45.7'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '56.7'}]}]}, {'title': 'Drowsiness/Somnolence', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '34.0'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '26.9'}]}]}, {'title': 'Hives or Welts/Urticaria', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '13.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \\<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}], 'classes': [{'title': 'Appetite lost/Decreased appetite', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '35.0'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '30.5'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '48.7'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '34.0'}]}]}, {'title': 'Drowsiness/Somnolence', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '36.7'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '28.7'}]}]}, {'title': 'Hives or Welts/Urticaria', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \\<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}], 'classes': [{'title': 'Joint pain/arthralgia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '4.9'}]}]}, {'title': 'Appetite lost/Decreased appetite', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.7'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '6.5'}]}]}, {'title': 'Tiredness/Fatigue', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '22.0'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '23.6'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '17.6'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '19.7'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '6.5'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '8.1'}]}]}, {'title': 'Muscle pain/Myalgia', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '30.7'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '22.9'}]}]}, {'title': 'Drowsiness/Somnolence', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '6.5'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '6.5'}]}]}, {'title': 'Hives or Welts/Urticaria', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '4.0'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '4.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days post vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \\<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.6'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~6 months post final vaccination', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group 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': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.8'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~6 months post final vaccination', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group 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': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~6 months post vaccination', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '99.6'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '99.0'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '90.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '93.9', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '25.4'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '22.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post final vaccination', 'description': 'Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group 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': 'The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 3 (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '96.2'}]}]}, {'title': 'Serotype 4 (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '88.5', 'upperLimit': '99.6'}]}]}, {'title': 'Serotype 5 (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6A (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '92.4'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '86.1', 'upperLimit': '99.0'}]}]}, {'title': 'Serotype 6B (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '96.0'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '77.4', 'upperLimit': '95.2'}]}]}, {'title': 'Serotype 7F (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '88.5', 'upperLimit': '99.6'}]}]}, {'title': 'Serotype 14 (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '99.6'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19A (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '98.9'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '77.4', 'upperLimit': '95.2'}]}]}, {'title': 'Serotype 22F (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '100.0'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '16.2'}]}]}, {'title': 'Serotype 33F (n=56,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '98.9'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '26.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post final vaccination', 'description': 'Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'OG001', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '98.2'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '81.6', 'upperLimit': '92.3'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '99.6'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '99.6'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '99.6'}, {'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '92.9', 'upperLimit': '99.0'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.9'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '99.6'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '91.3', 'upperLimit': '98.2'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '45.8'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '30.0', 'upperLimit': '45.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days post vaccination', 'description': 'Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group 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': 'The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'FG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'FG002', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'FG003', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'FG004', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'FG005', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '177'}, {'groupId': 'FG005', 'numSubjects': '175'}]}, {'type': 'PCV Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '177'}, {'groupId': 'FG005', 'numSubjects': '175'}]}, {'type': 'PCV Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'PCV Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '177'}, {'groupId': 'FG005', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawn by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of approximately 600 participants were planned for enrollment. Randomization was stratified by age and pneumococcal conjugate vaccine (PCV) history.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '177', 'groupId': 'BG004'}, {'value': '175', 'groupId': 'BG005'}, {'value': '606', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'V114, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'BG001', 'title': 'Prevnar 13®, Schedule A: Participants 7-11 Months', 'description': 'Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.'}, {'id': 'BG002', 'title': 'V114, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'BG003', 'title': 'Prevnar 13®, Schedule B: Participants 12-23 Months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.'}, {'id': 'BG004', 'title': 'V114, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'BG005', 'title': 'Prevnar 13®, Schedule C: Participants 2-17 Years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '7-11 Months', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '128', 'groupId': 'BG006'}]}, {'title': '12-23 Months', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '126', 'groupId': 'BG006'}]}, {'title': '≥2 to <6 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '112', 'groupId': 'BG005'}, {'value': '226', 'groupId': 'BG006'}]}, {'title': '≥6 to 17 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '126', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}, {'value': '298', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}, {'value': '92', 'groupId': 'BG005'}, {'value': '308', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}, {'value': '174', 'groupId': 'BG005'}, {'value': '603', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '327', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}, {'value': '118', 'groupId': 'BG005'}, {'value': '278', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-04', 'size': 977293, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-26T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2019-03-20', 'resultsFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-26', 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months', 'timeFrame': '30 days post last vaccination', 'description': 'The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'GMC of Serotype-specific IgG - Schedule B: 12-23 Months', 'timeFrame': '30 days post last vaccination', 'description': 'The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'GMC of Serotype-specific IgG - Schedule C: 2-17 Years', 'timeFrame': '30 days post vaccination', 'description': 'The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.'}, {'measure': 'Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.'}, {'measure': 'Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.'}, {'measure': 'Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years', 'timeFrame': 'Up to 14 days post vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \\<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months', 'timeFrame': 'Up to 14 days post any vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \\<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.'}, {'measure': 'Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years', 'timeFrame': 'Up to 14 days post vaccination', 'description': 'An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \\<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.'}, {'measure': 'Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months', 'timeFrame': 'Up to ~6 months post final vaccination', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group 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 at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months', 'timeFrame': 'Up to ~6 months post final vaccination', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group 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 at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years', 'timeFrame': 'Up to ~6 months post vaccination', 'description': 'A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months', 'timeFrame': '30 days post final vaccination', 'description': 'Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group 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 Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months', 'timeFrame': '30 days post final vaccination', 'description': 'Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.'}, {'measure': 'Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years', 'timeFrame': '30 days post vaccination', 'description': 'Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '36150974', 'type': 'RESULT', 'citation': 'Banniettis N, Wysocki J, Szenborn L, Phongsamart W, Pitisuttithum P, Ramet M, Richmond P, Shi Y, Dagan R, Good L, Papa M, Lupinacci R, McFetridge R, Tamms G, Churchill C, Musey L, Bickham K; V114-024 PNEU-PLAN study group. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325. doi: 10.1016/j.vaccine.2022.09.003. Epub 2022 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Not be pregnant or breastfeeding\n* Not be a woman of childbearing potential\n* If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention\n* Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent\n\nExclusion Criteria\n\n* History of invasive pneumococcal disease (IPD)\n* Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing vaccine\n* Had a recent febrile illness occurring within 72 hours prior to receipt of study vaccine\n* Known or suspected impairment of immunological function\n* History of congenital or acquired immunodeficiency\n* Has or his/her mother has a documented human immunodeficiency virus (HIV) infection\n* Known or history of functional or anatomic asplenia\n* Has failure to thrive based on the clinical judgement of the investigator\n* Has a bleeding disorder contraindicating intramuscular vaccination\n* Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)\n* Has known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders\n* Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants ≥2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine\n* Meets one or more of the following systemic corticosteroid exclusion criteria: has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \\>10 kg) for ≥14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization; has received or is expected to receive systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days prior to any dose of study vaccine; or is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study (Note: Topical, ophthalmic and inhaled steroids are permitted)\n* Has received other licensed non-live vaccines within 14 days before receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine\n* Has received a licensed live vaccine within 30 days before receipt of study vaccine\n* Has received a blood transfusion or blood products, including immunoglobulins, within 6 months before receipt of study vaccine\n* Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study"}, 'identificationModule': {'nctId': 'NCT03885934', 'acronym': 'PNEU-PLAN', 'briefTitle': 'Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)', '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 Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)', 'orgStudyIdInfo': {'id': 'V114-024'}, 'secondaryIdInfos': [{'id': '2018-003706-88', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V114, Schedule A: Participants 7-11 months', 'description': 'Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \\[PCV\\]-naïve)(3 doses). 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Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.', 'interventionNames': ['Biological: V114']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13®, Schedule B: Participants 12-23 months', 'description': 'Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.', 'interventionNames': ['Biological: Prevnar 13®']}, {'type': 'EXPERIMENTAL', 'label': 'V114, Schedule C: Participants 2-17 years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.', 'interventionNames': ['Biological: V114']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13®, Schedule C: Participants 2-17 years', 'description': 'Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.', 'interventionNames': ['Biological: Prevnar 13®']}], 'interventions': [{'name': 'V114', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™'], 'description': 'V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration', 'armGroupLabels': ['V114, Schedule A: Participants 7-11 months', 'V114, Schedule B: Participants 12-23 months', 'V114, Schedule C: Participants 2-17 years']}, {'name': 'Prevnar 13®', 'type': 'BIOLOGICAL', 'otherNames': ['PCV13'], 'description': 'Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.', 'armGroupLabels': ['Prevnar 13®, Schedule A: Participants 7-11 months', 'Prevnar 13®, Schedule B: Participants 12-23 months', 'Prevnar 13®, Schedule C: Participants 2-17 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02230', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '67100', 'city': 'Kokkola', 'country': 'Finland', 'facility': 'Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)', 'geoPoint': {'lat': 63.83847, 'lon': 23.13066}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '60100', 'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Seinajoki Vaccine Research Center ( Site 0010)', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '88996', 'city': 'Kota Kinabalu', 'country': 'Malaysia', 'facility': 'Sabah Womens & Childrens Hospital ( Site 0902)', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre ( Site 0901)', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '85-079', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Przychodnia Vitamed Gaaj i Cichomski Spolka Jawna ( Site 0212)', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-796', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Centrum Medyczne Pratia Bydgoszcz ( Site 0210)', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '61-709', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Spec Zesp Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu ( Site 0213)', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '41-103', 'city': 'Siemianowice Śląskie', 'country': 'Poland', 'facility': 'NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0211)', 'geoPoint': {'lat': 50.32738, 'lon': 19.02901}}, {'zip': '50-368', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny ( Site 0207)', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '05-092', 'city': 'Łomianki', 'country': 'Poland', 'facility': 'SPZOZ im. 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