Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04583618
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2020-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610 ext: 6#', 'title': 'Trial Transparency Team', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days.', 'description': 'Analysis was performed on SafAS.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 113, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 122, 'seriousNumAtRisk': 151, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 112, 'seriousNumAtRisk': 148, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 102, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 93, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 106, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 113, 'numAffected': 113}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 107, 'numAffected': 107}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 74, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 58, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 72, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 50, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 65, 'numAffected': 65}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 51, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 44, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Oropharyngeal Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Plasma Cell Myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '177'}, {'value': '127', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '178'}, {'value': '158', 'groupId': 'OG002', 'lowerLimit': '113', 'upperLimit': '220'}, {'value': '254', 'groupId': 'OG003', 'lowerLimit': '183', 'upperLimit': '353'}, {'value': '289', 'groupId': 'OG004', 'lowerLimit': '213', 'upperLimit': '392'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '170'}, {'value': '217', 'groupId': 'OG001', 'lowerLimit': '176', 'upperLimit': '269'}, {'value': '263', 'groupId': 'OG002', 'lowerLimit': '214', 'upperLimit': '323'}, {'value': '157', 'groupId': 'OG003', 'lowerLimit': '126', 'upperLimit': '196'}, {'value': '177', 'groupId': 'OG004', 'lowerLimit': '142', 'upperLimit': '221'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1494', 'groupId': 'OG000', 'lowerLimit': '1175', 'upperLimit': '1900'}, {'value': '1306', 'groupId': 'OG001', 'lowerLimit': '1029', 'upperLimit': '1658'}, {'value': '2134', 'groupId': 'OG002', 'lowerLimit': '1675', 'upperLimit': '2719'}, {'value': '2941', 'groupId': 'OG003', 'lowerLimit': '2360', 'upperLimit': '3664'}, {'value': '1873', 'groupId': 'OG004', 'lowerLimit': '1415', 'upperLimit': '2480'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '166', 'upperLimit': '349'}, {'value': '230', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '330'}, {'value': '201', 'groupId': 'OG002', 'lowerLimit': '143', 'upperLimit': '281'}, {'value': '536', 'groupId': 'OG003', 'lowerLimit': '378', 'upperLimit': '760'}, {'value': '377', 'groupId': 'OG004', 'lowerLimit': '272', 'upperLimit': '523'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2931', 'groupId': 'OG000', 'lowerLimit': '2143', 'upperLimit': '4010'}, {'value': '3074', 'groupId': 'OG001', 'lowerLimit': '2389', 'upperLimit': '3957'}, {'value': '2672', 'groupId': 'OG002', 'lowerLimit': '1923', 'upperLimit': '3714'}, {'value': '3350', 'groupId': 'OG003', 'lowerLimit': '2418', 'upperLimit': '4641'}, {'value': '443', 'groupId': 'OG004', 'lowerLimit': '288', 'upperLimit': '681'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3699', 'groupId': 'OG000', 'lowerLimit': '2857', 'upperLimit': '4788'}, {'value': '3582', 'groupId': 'OG001', 'lowerLimit': '2763', 'upperLimit': '4645'}, {'value': '3479', 'groupId': 'OG002', 'lowerLimit': '2595', 'upperLimit': '4664'}, {'value': '5122', 'groupId': 'OG003', 'lowerLimit': '3916', 'upperLimit': '6699'}, {'value': '2153', 'groupId': 'OG004', 'lowerLimit': '1561', 'upperLimit': '2969'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3487', 'groupId': 'OG000', 'lowerLimit': '2811', 'upperLimit': '4326'}, {'value': '2841', 'groupId': 'OG001', 'lowerLimit': '2262', 'upperLimit': '3568'}, {'value': '2403', 'groupId': 'OG002', 'lowerLimit': '1878', 'upperLimit': '3074'}, {'value': '4253', 'groupId': 'OG003', 'lowerLimit': '3309', 'upperLimit': '5466'}, {'value': '2250', 'groupId': 'OG004', 'lowerLimit': '1721', 'upperLimit': '2943'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '826', 'groupId': 'OG000', 'lowerLimit': '607', 'upperLimit': '1123'}, {'value': '828', 'groupId': 'OG001', 'lowerLimit': '614', 'upperLimit': '1117'}, {'value': '986', 'groupId': 'OG002', 'lowerLimit': '700', 'upperLimit': '1388'}, {'value': '1641', 'groupId': 'OG003', 'lowerLimit': '1274', 'upperLimit': '2114'}, {'value': '1159', 'groupId': 'OG004', 'lowerLimit': '863', 'upperLimit': '1556'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3756', 'groupId': 'OG000', 'lowerLimit': '2995', 'upperLimit': '4709'}, {'value': '4407', 'groupId': 'OG001', 'lowerLimit': '3385', 'upperLimit': '5737'}, {'value': '3244', 'groupId': 'OG002', 'lowerLimit': '2421', 'upperLimit': '4349'}, {'value': '3675', 'groupId': 'OG003', 'lowerLimit': '2904', 'upperLimit': '4650'}, {'value': '3999', 'groupId': 'OG004', 'lowerLimit': '3099', 'upperLimit': '5161'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '905', 'groupId': 'OG000', 'lowerLimit': '676', 'upperLimit': '1210'}, {'value': '802', 'groupId': 'OG001', 'lowerLimit': '590', 'upperLimit': '1090'}, {'value': '1025', 'groupId': 'OG002', 'lowerLimit': '756', 'upperLimit': '1390'}, {'value': '1929', 'groupId': 'OG003', 'lowerLimit': '1460', 'upperLimit': '2548'}, {'value': '1177', 'groupId': 'OG004', 'lowerLimit': '875', 'upperLimit': '1585'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2067', 'groupId': 'OG000', 'lowerLimit': '1719', 'upperLimit': '2485'}, {'value': '3395', 'groupId': 'OG001', 'lowerLimit': '2796', 'upperLimit': '4123'}, {'value': '3462', 'groupId': 'OG002', 'lowerLimit': '2771', 'upperLimit': '4324'}, {'value': '4417', 'groupId': 'OG003', 'lowerLimit': '3537', 'upperLimit': '5515'}, {'value': '2261', 'groupId': 'OG004', 'lowerLimit': '1841', 'upperLimit': '2776'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '897', 'groupId': 'OG000', 'lowerLimit': '702', 'upperLimit': '1145'}, {'value': '1773', 'groupId': 'OG001', 'lowerLimit': '1406', 'upperLimit': '2236'}, {'value': '1678', 'groupId': 'OG002', 'lowerLimit': '1336', 'upperLimit': '2108'}, {'value': '1525', 'groupId': 'OG003', 'lowerLimit': '1165', 'upperLimit': '1997'}, {'value': '983', 'groupId': 'OG004', 'lowerLimit': '742', 'upperLimit': '1303'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1999', 'groupId': 'OG000', 'lowerLimit': '1478', 'upperLimit': '2704'}, {'value': '1576', 'groupId': 'OG001', 'lowerLimit': '1153', 'upperLimit': '2153'}, {'value': '1701', 'groupId': 'OG002', 'lowerLimit': '1284', 'upperLimit': '2255'}, {'value': '1792', 'groupId': 'OG003', 'lowerLimit': '1311', 'upperLimit': '2450'}, {'value': '488', 'groupId': 'OG004', 'lowerLimit': '319', 'upperLimit': '747'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1363', 'groupId': 'OG000', 'lowerLimit': '1110', 'upperLimit': '1674'}, {'value': '1377', 'groupId': 'OG001', 'lowerLimit': '1129', 'upperLimit': '1680'}, {'value': '1486', 'groupId': 'OG002', 'lowerLimit': '1207', 'upperLimit': '1829'}, {'value': '74.8', 'groupId': 'OG003', 'lowerLimit': '52.3', 'upperLimit': '107'}, {'value': '2039', 'groupId': 'OG004', 'lowerLimit': '1664', 'upperLimit': '2499'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3656', 'groupId': 'OG000', 'lowerLimit': '2988', 'upperLimit': '4474'}, {'value': '3858', 'groupId': 'OG001', 'lowerLimit': '3145', 'upperLimit': '4733'}, {'value': '4207', 'groupId': 'OG002', 'lowerLimit': '3430', 'upperLimit': '5160'}, {'value': '1082', 'groupId': 'OG003', 'lowerLimit': '806', 'upperLimit': '1453'}, {'value': '6096', 'groupId': 'OG004', 'lowerLimit': '4837', 'upperLimit': '7682'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3501', 'groupId': 'OG000', 'lowerLimit': '2689', 'upperLimit': '4557'}, {'value': '2856', 'groupId': 'OG001', 'lowerLimit': '2190', 'upperLimit': '3724'}, {'value': '2811', 'groupId': 'OG002', 'lowerLimit': '2047', 'upperLimit': '3860'}, {'value': '104', 'groupId': 'OG003', 'lowerLimit': '64.3', 'upperLimit': '167'}, {'value': '3011', 'groupId': 'OG004', 'lowerLimit': '2060', 'upperLimit': '4399'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000', 'lowerLimit': '354', 'upperLimit': '637'}, {'value': '438', 'groupId': 'OG001', 'lowerLimit': '324', 'upperLimit': '594'}, {'value': '318', 'groupId': 'OG002', 'lowerLimit': '226', 'upperLimit': '448'}, {'value': '18.3', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '25.6'}, {'value': '390', 'groupId': 'OG004', 'lowerLimit': '285', 'upperLimit': '534'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3492', 'groupId': 'OG000', 'lowerLimit': '2587', 'upperLimit': '4714'}, {'value': '3917', 'groupId': 'OG001', 'lowerLimit': '3116', 'upperLimit': '4925'}, {'value': '3117', 'groupId': 'OG002', 'lowerLimit': '2311', 'upperLimit': '4203'}, {'value': '8.31', 'groupId': 'OG003', 'lowerLimit': '6.19', 'upperLimit': '11.2'}, {'value': '1345', 'groupId': 'OG004', 'lowerLimit': '914', 'upperLimit': '1980'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '132', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4930', 'groupId': 'OG000', 'lowerLimit': '3641', 'upperLimit': '6677'}, {'value': '4823', 'groupId': 'OG001', 'lowerLimit': '3588', 'upperLimit': '6484'}, {'value': '3613', 'groupId': 'OG002', 'lowerLimit': '2541', 'upperLimit': '5138'}, {'value': '160', 'groupId': 'OG003', 'lowerLimit': '112', 'upperLimit': '230'}, {'value': '3346', 'groupId': 'OG004', 'lowerLimit': '2409', 'upperLimit': '4648'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5253', 'groupId': 'OG000', 'lowerLimit': '4147', 'upperLimit': '6653'}, {'value': '4639', 'groupId': 'OG001', 'lowerLimit': '3587', 'upperLimit': '6001'}, {'value': '4858', 'groupId': 'OG002', 'lowerLimit': '3683', 'upperLimit': '6406'}, {'value': '62.5', 'groupId': 'OG003', 'lowerLimit': '42.4', 'upperLimit': '92.1'}, {'value': '1906', 'groupId': 'OG004', 'lowerLimit': '1456', 'upperLimit': '2495'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7313', 'groupId': 'OG000', 'lowerLimit': '5890', 'upperLimit': '9078'}, {'value': '8324', 'groupId': 'OG001', 'lowerLimit': '6488', 'upperLimit': '10680'}, {'value': '7641', 'groupId': 'OG002', 'lowerLimit': '6205', 'upperLimit': '9410'}, {'value': '1201', 'groupId': 'OG003', 'lowerLimit': '898', 'upperLimit': '1605'}, {'value': '15082', 'groupId': 'OG004', 'lowerLimit': '11551', 'upperLimit': '19692'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Post-vaccination at Day 31', 'description': 'The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.40', 'groupId': 'OG000', 'lowerLimit': '6.28', 'upperLimit': '11.2'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '7.95', 'upperLimit': '14.0'}, {'value': '9.79', 'groupId': 'OG002', 'lowerLimit': '7.15', 'upperLimit': '13.4'}, {'value': '21.3', 'groupId': 'OG003', 'lowerLimit': '15.6', 'upperLimit': '29.0'}, {'value': '19.1', 'groupId': 'OG004', 'lowerLimit': '14.4', 'upperLimit': '25.3'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.06', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '8.99'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '16.4'}, {'value': '13.7', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '17.4'}, {'value': '8.52', 'groupId': 'OG003', 'lowerLimit': '6.71', 'upperLimit': '10.8'}, {'value': '9.52', 'groupId': 'OG004', 'lowerLimit': '7.56', 'upperLimit': '12.0'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '29.3'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '40.3'}, {'value': '33.0', 'groupId': 'OG002', 'lowerLimit': '22.2', 'upperLimit': '49.2'}, {'value': '58.9', 'groupId': 'OG003', 'lowerLimit': '41.2', 'upperLimit': '84.1'}, {'value': '25.7', 'groupId': 'OG004', 'lowerLimit': '18.2', 'upperLimit': '36.4'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '21.0'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '26.7'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '9.10', 'upperLimit': '16.4'}, {'value': '37.4', 'groupId': 'OG003', 'lowerLimit': '26.9', 'upperLimit': '52.1'}, {'value': '24.2', 'groupId': 'OG004', 'lowerLimit': '18.2', 'upperLimit': '32.2'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '132', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '42.8', 'upperLimit': '86.5'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '48.3', 'upperLimit': '99.8'}, {'value': '59.2', 'groupId': 'OG002', 'lowerLimit': '40.9', 'upperLimit': '85.8'}, {'value': '79.1', 'groupId': 'OG003', 'lowerLimit': '54.4', 'upperLimit': '115'}, {'value': '9.18', 'groupId': 'OG004', 'lowerLimit': '6.34', 'upperLimit': '13.3'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '41.2'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '36.6'}, {'value': '29.2', 'groupId': 'OG002', 'lowerLimit': '19.5', 'upperLimit': '43.6'}, {'value': '49.3', 'groupId': 'OG003', 'lowerLimit': '34.8', 'upperLimit': '69.7'}, {'value': '16.6', 'groupId': 'OG004', 'lowerLimit': '11.5', 'upperLimit': '23.8'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '32.8', 'upperLimit': '78.9'}, {'value': '49.0', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '73.7'}, {'value': '24.0', 'groupId': 'OG002', 'lowerLimit': '14.9', 'upperLimit': '38.7'}, {'value': '79.1', 'groupId': 'OG003', 'lowerLimit': '51.6', 'upperLimit': '121'}, {'value': '31.0', 'groupId': 'OG004', 'lowerLimit': '21.0', 'upperLimit': '45.8'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.50', 'groupId': 'OG000', 'lowerLimit': '7.01', 'upperLimit': '12.9'}, {'value': '9.90', 'groupId': 'OG001', 'lowerLimit': '7.20', 'upperLimit': '13.6'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '8.90', 'upperLimit': '18.0'}, {'value': '17.2', 'groupId': 'OG003', 'lowerLimit': '12.2', 'upperLimit': '24.1'}, {'value': '10.6', 'groupId': 'OG004', 'lowerLimit': '7.78', 'upperLimit': '14.4'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.44', 'groupId': 'OG000', 'lowerLimit': '5.25', 'upperLimit': '10.5'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '9.69', 'upperLimit': '21.0'}, {'value': '8.44', 'groupId': 'OG002', 'lowerLimit': '5.68', 'upperLimit': '12.5'}, {'value': '10.1', 'groupId': 'OG003', 'lowerLimit': '7.03', 'upperLimit': '14.6'}, {'value': '9.05', 'groupId': 'OG004', 'lowerLimit': '6.46', 'upperLimit': '12.7'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '23.3'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '28.2'}, {'value': '18.9', 'groupId': 'OG002', 'lowerLimit': '13.3', 'upperLimit': '27.0'}, {'value': '43.1', 'groupId': 'OG003', 'lowerLimit': '31.1', 'upperLimit': '59.8'}, {'value': '22.1', 'groupId': 'OG004', 'lowerLimit': '16.3', 'upperLimit': '30.0'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.36', 'groupId': 'OG000', 'lowerLimit': '5.77', 'upperLimit': '9.38'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '16.8'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '8.66', 'upperLimit': '15.3'}, {'value': '15.5', 'groupId': 'OG003', 'lowerLimit': '11.4', 'upperLimit': '21.0'}, {'value': '7.88', 'groupId': 'OG004', 'lowerLimit': '6.26', 'upperLimit': '9.91'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '9.45', 'upperLimit': '18.2'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '43.0'}, {'value': '20.8', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '29.0'}, {'value': '26.6', 'groupId': 'OG003', 'lowerLimit': '19.0', 'upperLimit': '37.1'}, {'value': '17.2', 'groupId': 'OG004', 'lowerLimit': '12.5', 'upperLimit': '23.7'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '31.0', 'upperLimit': '65.9'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '63.8'}, {'value': '43.9', 'groupId': 'OG002', 'lowerLimit': '29.6', 'upperLimit': '65.1'}, {'value': '45.5', 'groupId': 'OG003', 'lowerLimit': '32.2', 'upperLimit': '64.4'}, {'value': '11.6', 'groupId': 'OG004', 'lowerLimit': '7.99', 'upperLimit': '16.8'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '25.6'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '32.8'}, {'value': '24.0', 'groupId': 'OG002', 'lowerLimit': '16.3', 'upperLimit': '35.3'}, {'value': '1.37', 'groupId': 'OG003', 'lowerLimit': '1.14', 'upperLimit': '1.65'}, {'value': '37.6', 'groupId': 'OG004', 'lowerLimit': '27.8', 'upperLimit': '50.8'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}, {'value': '133', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.90', 'groupId': 'OG000', 'lowerLimit': '6.29', 'upperLimit': '12.6'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '8.90', 'upperLimit': '18.4'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '7.88', 'upperLimit': '16.8'}, {'value': '2.84', 'groupId': 'OG003', 'lowerLimit': '2.12', 'upperLimit': '3.79'}, {'value': '14.6', 'groupId': 'OG004', 'lowerLimit': '10.7', 'upperLimit': '20.0'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '130', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '35.8'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '36.9'}, {'value': '20.8', 'groupId': 'OG002', 'lowerLimit': '13.4', 'upperLimit': '32.3'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '0.932', 'upperLimit': '1.19'}, {'value': '22.9', 'groupId': 'OG004', 'lowerLimit': '16.1', 'upperLimit': '32.7'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '21.0'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '22.6'}, {'value': '9.28', 'groupId': 'OG002', 'lowerLimit': '6.46', 'upperLimit': '13.3'}, {'value': '0.964', 'groupId': 'OG003', 'lowerLimit': '0.786', 'upperLimit': '1.18'}, {'value': '13.7', 'groupId': 'OG004', 'lowerLimit': '9.64', 'upperLimit': '19.5'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000', 'lowerLimit': '163', 'upperLimit': '354'}, {'value': '252', 'groupId': 'OG001', 'lowerLimit': '181', 'upperLimit': '353'}, {'value': '167', 'groupId': 'OG002', 'lowerLimit': '106', 'upperLimit': '263'}, {'value': '0.975', 'groupId': 'OG003', 'lowerLimit': '0.870', 'upperLimit': '1.09'}, {'value': '102', 'groupId': 'OG004', 'lowerLimit': '67.7', 'upperLimit': '153'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}, {'value': '128', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '20.8', 'upperLimit': '43.6'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '50.5'}, {'value': '20.7', 'groupId': 'OG002', 'lowerLimit': '14.1', 'upperLimit': '30.4'}, {'value': '1.21', 'groupId': 'OG003', 'lowerLimit': '0.997', 'upperLimit': '1.47'}, {'value': '22.8', 'groupId': 'OG004', 'lowerLimit': '16.1', 'upperLimit': '32.1'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}, {'value': '129', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '56.1'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '60.3'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '25.4', 'upperLimit': '58.3'}, {'value': '0.878', 'groupId': 'OG003', 'lowerLimit': '0.679', 'upperLimit': '1.14'}, {'value': '21.0', 'groupId': 'OG004', 'lowerLimit': '15.1', 'upperLimit': '29.1'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.21', 'groupId': 'OG000', 'lowerLimit': '3.27', 'upperLimit': '5.41'}, {'value': '6.27', 'groupId': 'OG001', 'lowerLimit': '4.72', 'upperLimit': '8.32'}, {'value': '4.36', 'groupId': 'OG002', 'lowerLimit': '3.45', 'upperLimit': '5.52'}, {'value': '0.931', 'groupId': 'OG003', 'lowerLimit': '0.871', 'upperLimit': '0.995'}, {'value': '10.4', 'groupId': 'OG004', 'lowerLimit': '7.76', 'upperLimit': '13.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31', 'description': 'The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '3.88'}, {'value': '3.28', 'groupId': 'OG001', 'lowerLimit': '2.59', 'upperLimit': '4.17'}, {'value': '4.17', 'groupId': 'OG002', 'lowerLimit': '3.29', 'upperLimit': '5.28'}, {'value': '5.93', 'groupId': 'OG003', 'lowerLimit': '4.49', 'upperLimit': '7.85'}, {'value': '7.43', 'groupId': 'OG004', 'lowerLimit': '5.75', 'upperLimit': '9.60'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.746', 'groupId': 'OG000', 'lowerLimit': '0.616', 'upperLimit': '0.903'}, {'value': '0.977', 'groupId': 'OG001', 'lowerLimit': '0.818', 'upperLimit': '1.17'}, {'value': '1.22', 'groupId': 'OG002', 'lowerLimit': '1.01', 'upperLimit': '1.49'}, {'value': '0.899', 'groupId': 'OG003', 'lowerLimit': '0.738', 'upperLimit': '1.10'}, {'value': '0.858', 'groupId': 'OG004', 'lowerLimit': '0.717', 'upperLimit': '1.03'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '2.43'}, {'value': '1.63', 'groupId': 'OG001', 'lowerLimit': '1.32', 'upperLimit': '2.00'}, {'value': '2.27', 'groupId': 'OG002', 'lowerLimit': '1.81', 'upperLimit': '2.84'}, {'value': '3.28', 'groupId': 'OG003', 'lowerLimit': '2.61', 'upperLimit': '4.12'}, {'value': '1.72', 'groupId': 'OG004', 'lowerLimit': '1.38', 'upperLimit': '2.13'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '3.10'}, {'value': '2.16', 'groupId': 'OG001', 'lowerLimit': '1.62', 'upperLimit': '2.87'}, {'value': '2.16', 'groupId': 'OG002', 'lowerLimit': '1.68', 'upperLimit': '2.78'}, {'value': '4.34', 'groupId': 'OG003', 'lowerLimit': '3.20', 'upperLimit': '5.90'}, {'value': '3.98', 'groupId': 'OG004', 'lowerLimit': '3.09', 'upperLimit': '5.12'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.04', 'groupId': 'OG000', 'lowerLimit': '4.45', 'upperLimit': '8.22'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '3.83', 'upperLimit': '6.54'}, {'value': '4.83', 'groupId': 'OG002', 'lowerLimit': '3.57', 'upperLimit': '6.54'}, {'value': '7.89', 'groupId': 'OG003', 'lowerLimit': '5.90', 'upperLimit': '10.5'}, {'value': '1.53', 'groupId': 'OG004', 'lowerLimit': '1.16', 'upperLimit': '2.02'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.73', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '7.89'}, {'value': '3.62', 'groupId': 'OG001', 'lowerLimit': '2.66', 'upperLimit': '4.93'}, {'value': '4.37', 'groupId': 'OG002', 'lowerLimit': '3.22', 'upperLimit': '5.95'}, {'value': '6.45', 'groupId': 'OG003', 'lowerLimit': '4.92', 'upperLimit': '8.45'}, {'value': '2.47', 'groupId': 'OG004', 'lowerLimit': '1.86', 'upperLimit': '3.28'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.56', 'groupId': 'OG000', 'lowerLimit': '5.23', 'upperLimit': '8.22'}, {'value': '5.56', 'groupId': 'OG001', 'lowerLimit': '4.58', 'upperLimit': '6.75'}, {'value': '5.35', 'groupId': 'OG002', 'lowerLimit': '4.30', 'upperLimit': '6.65'}, {'value': '10.1', 'groupId': 'OG003', 'lowerLimit': '8.01', 'upperLimit': '12.6'}, {'value': '4.23', 'groupId': 'OG004', 'lowerLimit': '3.34', 'upperLimit': '5.35'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '3.72'}, {'value': '3.17', 'groupId': 'OG001', 'lowerLimit': '2.52', 'upperLimit': '4.00'}, {'value': '4.31', 'groupId': 'OG002', 'lowerLimit': '3.43', 'upperLimit': '5.41'}, {'value': '5.30', 'groupId': 'OG003', 'lowerLimit': '4.20', 'upperLimit': '6.68'}, {'value': '3.48', 'groupId': 'OG004', 'lowerLimit': '2.75', 'upperLimit': '4.41'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '9.88', 'upperLimit': '15.7'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '8.21', 'upperLimit': '13.6'}, {'value': '9.52', 'groupId': 'OG002', 'lowerLimit': '7.34', 'upperLimit': '12.3'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '8.22', 'upperLimit': '13.4'}, {'value': '14.6', 'groupId': 'OG004', 'lowerLimit': '11.2', 'upperLimit': '19.0'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.50', 'groupId': 'OG000', 'lowerLimit': '4.44', 'upperLimit': '6.82'}, {'value': '5.39', 'groupId': 'OG001', 'lowerLimit': '4.39', 'upperLimit': '6.62'}, {'value': '5.41', 'groupId': 'OG002', 'lowerLimit': '4.44', 'upperLimit': '6.59'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '8.15', 'upperLimit': '13.1'}, {'value': '5.44', 'groupId': 'OG004', 'lowerLimit': '4.34', 'upperLimit': '6.81'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.41', 'groupId': 'OG000', 'lowerLimit': '6.03', 'upperLimit': '9.10'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '9.16', 'upperLimit': '15.1'}, {'value': '10.9', 'groupId': 'OG002', 'lowerLimit': '8.41', 'upperLimit': '14.2'}, {'value': '18.3', 'groupId': 'OG003', 'lowerLimit': '14.4', 'upperLimit': '23.2'}, {'value': '7.59', 'groupId': 'OG004', 'lowerLimit': '6.05', 'upperLimit': '9.52'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.77', 'groupId': 'OG000', 'lowerLimit': '2.92', 'upperLimit': '4.87'}, {'value': '8.35', 'groupId': 'OG001', 'lowerLimit': '6.22', 'upperLimit': '11.2'}, {'value': '7.03', 'groupId': 'OG002', 'lowerLimit': '5.30', 'upperLimit': '9.33'}, {'value': '9.38', 'groupId': 'OG003', 'lowerLimit': '7.16', 'upperLimit': '12.3'}, {'value': '4.47', 'groupId': 'OG004', 'lowerLimit': '3.40', 'upperLimit': '5.88'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.35', 'groupId': 'OG000', 'lowerLimit': '5.56', 'upperLimit': '9.72'}, {'value': '5.52', 'groupId': 'OG001', 'lowerLimit': '4.26', 'upperLimit': '7.13'}, {'value': '6.59', 'groupId': 'OG002', 'lowerLimit': '5.05', 'upperLimit': '8.61'}, {'value': '6.99', 'groupId': 'OG003', 'lowerLimit': '5.33', 'upperLimit': '9.17'}, {'value': '3.02', 'groupId': 'OG004', 'lowerLimit': '2.31', 'upperLimit': '3.96'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.14', 'groupId': 'OG000', 'lowerLimit': '5.75', 'upperLimit': '8.87'}, {'value': '6.25', 'groupId': 'OG001', 'lowerLimit': '5.09', 'upperLimit': '7.68'}, {'value': '6.23', 'groupId': 'OG002', 'lowerLimit': '4.98', 'upperLimit': '7.80'}, {'value': '0.935', 'groupId': 'OG003', 'lowerLimit': '0.703', 'upperLimit': '1.24'}, {'value': '9.84', 'groupId': 'OG004', 'lowerLimit': '8.14', 'upperLimit': '11.9'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.26', 'groupId': 'OG000', 'lowerLimit': '4.06', 'upperLimit': '6.81'}, {'value': '4.50', 'groupId': 'OG001', 'lowerLimit': '3.55', 'upperLimit': '5.71'}, {'value': '6.54', 'groupId': 'OG002', 'lowerLimit': '5.09', 'upperLimit': '8.40'}, {'value': '1.60', 'groupId': 'OG003', 'lowerLimit': '1.20', 'upperLimit': '2.12'}, {'value': '6.41', 'groupId': 'OG004', 'lowerLimit': '5.10', 'upperLimit': '8.06'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.16', 'groupId': 'OG000', 'lowerLimit': '5.37', 'upperLimit': '9.55'}, {'value': '9.48', 'groupId': 'OG001', 'lowerLimit': '7.10', 'upperLimit': '12.6'}, {'value': '7.37', 'groupId': 'OG002', 'lowerLimit': '5.39', 'upperLimit': '10.1'}, {'value': '1.06', 'groupId': 'OG003', 'lowerLimit': '0.840', 'upperLimit': '1.35'}, {'value': '9.11', 'groupId': 'OG004', 'lowerLimit': '6.83', 'upperLimit': '12.1'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.85', 'groupId': 'OG000', 'lowerLimit': '3.99', 'upperLimit': '5.89'}, {'value': '4.91', 'groupId': 'OG001', 'lowerLimit': '4.08', 'upperLimit': '5.89'}, {'value': '4.27', 'groupId': 'OG002', 'lowerLimit': '3.51', 'upperLimit': '5.20'}, {'value': '0.884', 'groupId': 'OG003', 'lowerLimit': '0.745', 'upperLimit': '1.05'}, {'value': '3.88', 'groupId': 'OG004', 'lowerLimit': '3.19', 'upperLimit': '4.72'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '1.58', 'upperLimit': '3.02'}, {'value': '2.09', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '2.83'}, {'value': '1.90', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '2.55'}, {'value': '0.190', 'groupId': 'OG003', 'lowerLimit': '0.158', 'upperLimit': '0.228'}, {'value': '1.03', 'groupId': 'OG004', 'lowerLimit': '0.780', 'upperLimit': '1.36'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '17.2'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '20.8'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '11.7', 'upperLimit': '18.8'}, {'value': '1.84', 'groupId': 'OG003', 'lowerLimit': '1.42', 'upperLimit': '2.39'}, {'value': '13.6', 'groupId': 'OG004', 'lowerLimit': '10.8', 'upperLimit': '17.2'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.57', 'groupId': 'OG000', 'lowerLimit': '2.88', 'upperLimit': '4.44'}, {'value': '4.02', 'groupId': 'OG001', 'lowerLimit': '3.20', 'upperLimit': '5.05'}, {'value': '3.78', 'groupId': 'OG002', 'lowerLimit': '3.03', 'upperLimit': '4.71'}, {'value': '0.350', 'groupId': 'OG003', 'lowerLimit': '0.283', 'upperLimit': '0.433'}, {'value': '2.41', 'groupId': 'OG004', 'lowerLimit': '1.93', 'upperLimit': '3.00'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.98', 'groupId': 'OG000', 'lowerLimit': '6.19', 'upperLimit': '10.3'}, {'value': '9.15', 'groupId': 'OG001', 'lowerLimit': '7.42', 'upperLimit': '11.3'}, {'value': '7.75', 'groupId': 'OG002', 'lowerLimit': '6.18', 'upperLimit': '9.72'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '1.21', 'upperLimit': '1.85'}, {'value': '16.4', 'groupId': 'OG004', 'lowerLimit': '12.8', 'upperLimit': '21.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Post-vaccination at Day 31', 'description': 'The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.39', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '6.70'}, {'value': '6.47', 'groupId': 'OG001', 'lowerLimit': '5.27', 'upperLimit': '7.95'}, {'value': '6.41', 'groupId': 'OG002', 'lowerLimit': '5.11', 'upperLimit': '8.03'}, {'value': '11.6', 'groupId': 'OG003', 'lowerLimit': '9.21', 'upperLimit': '14.6'}, {'value': '11.5', 'groupId': 'OG004', 'lowerLimit': '9.09', 'upperLimit': '14.5'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.49', 'upperLimit': '3.61'}, {'value': '4.02', 'groupId': 'OG001', 'lowerLimit': '3.40', 'upperLimit': '4.76'}, {'value': '4.93', 'groupId': 'OG002', 'lowerLimit': '4.07', 'upperLimit': '5.97'}, {'value': '3.86', 'groupId': 'OG003', 'lowerLimit': '3.21', 'upperLimit': '4.65'}, {'value': '3.52', 'groupId': 'OG004', 'lowerLimit': '3.01', 'upperLimit': '4.12'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.52', 'groupId': 'OG000', 'lowerLimit': '5.32', 'upperLimit': '7.98'}, {'value': '5.91', 'groupId': 'OG001', 'lowerLimit': '4.93', 'upperLimit': '7.07'}, {'value': '7.33', 'groupId': 'OG002', 'lowerLimit': '5.90', 'upperLimit': '9.10'}, {'value': '10.8', 'groupId': 'OG003', 'lowerLimit': '8.71', 'upperLimit': '13.3'}, {'value': '5.47', 'groupId': 'OG004', 'lowerLimit': '4.57', 'upperLimit': '6.55'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.43', 'groupId': 'OG000', 'lowerLimit': '4.32', 'upperLimit': '6.82'}, {'value': '5.81', 'groupId': 'OG001', 'lowerLimit': '4.67', 'upperLimit': '7.22'}, {'value': '4.60', 'groupId': 'OG002', 'lowerLimit': '3.75', 'upperLimit': '5.66'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '8.15', 'upperLimit': '13.7'}, {'value': '8.93', 'groupId': 'OG004', 'lowerLimit': '7.15', 'upperLimit': '11.1'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '18.2'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '9.79', 'upperLimit': '15.3'}, {'value': '12.6', 'groupId': 'OG002', 'lowerLimit': '9.76', 'upperLimit': '16.4'}, {'value': '19.3', 'groupId': 'OG003', 'lowerLimit': '14.9', 'upperLimit': '24.9'}, {'value': '3.30', 'groupId': 'OG004', 'lowerLimit': '2.75', 'upperLimit': '3.96'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '9.31', 'upperLimit': '16.0'}, {'value': '9.63', 'groupId': 'OG001', 'lowerLimit': '7.59', 'upperLimit': '12.2'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '8.10', 'upperLimit': '14.0'}, {'value': '16.2', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '20.5'}, {'value': '5.51', 'groupId': 'OG004', 'lowerLimit': '4.51', 'upperLimit': '6.74'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '8.37', 'upperLimit': '13.4'}, {'value': '9.67', 'groupId': 'OG001', 'lowerLimit': '7.86', 'upperLimit': '11.9'}, {'value': '7.93', 'groupId': 'OG002', 'lowerLimit': '6.30', 'upperLimit': '9.99'}, {'value': '16.3', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '20.7'}, {'value': '6.80', 'groupId': 'OG004', 'lowerLimit': '5.67', 'upperLimit': '8.16'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.65', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '6.95'}, {'value': '6.29', 'groupId': 'OG001', 'lowerLimit': '5.09', 'upperLimit': '7.76'}, {'value': '7.87', 'groupId': 'OG002', 'lowerLimit': '6.28', 'upperLimit': '9.86'}, {'value': '9.12', 'groupId': 'OG003', 'lowerLimit': '7.53', 'upperLimit': '11.0'}, {'value': '6.30', 'groupId': 'OG004', 'lowerLimit': '5.17', 'upperLimit': '7.68'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '139', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.91', 'groupId': 'OG000', 'lowerLimit': '3.93', 'upperLimit': '6.13'}, {'value': '6.44', 'groupId': 'OG001', 'lowerLimit': '5.06', 'upperLimit': '8.19'}, {'value': '4.62', 'groupId': 'OG002', 'lowerLimit': '3.59', 'upperLimit': '5.95'}, {'value': '5.96', 'groupId': 'OG003', 'lowerLimit': '4.68', 'upperLimit': '7.58'}, {'value': '7.35', 'groupId': 'OG004', 'lowerLimit': '5.85', 'upperLimit': '9.23'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.52', 'groupId': 'OG000', 'lowerLimit': '5.26', 'upperLimit': '8.08'}, {'value': '7.18', 'groupId': 'OG001', 'lowerLimit': '5.86', 'upperLimit': '8.79'}, {'value': '6.21', 'groupId': 'OG002', 'lowerLimit': '5.09', 'upperLimit': '7.58'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '9.52', 'upperLimit': '15.3'}, {'value': '6.91', 'groupId': 'OG004', 'lowerLimit': '5.74', 'upperLimit': '8.31'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.74', 'groupId': 'OG000', 'lowerLimit': '3.89', 'upperLimit': '5.78'}, {'value': '8.76', 'groupId': 'OG001', 'lowerLimit': '7.14', 'upperLimit': '10.7'}, {'value': '7.86', 'groupId': 'OG002', 'lowerLimit': '6.28', 'upperLimit': '9.84'}, {'value': '12.3', 'groupId': 'OG003', 'lowerLimit': '9.79', 'upperLimit': '15.4'}, {'value': '5.74', 'groupId': 'OG004', 'lowerLimit': '4.72', 'upperLimit': '6.98'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.97', 'groupId': 'OG000', 'lowerLimit': '4.02', 'upperLimit': '6.15'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '8.82', 'upperLimit': '14.3'}, {'value': '9.65', 'groupId': 'OG002', 'lowerLimit': '7.53', 'upperLimit': '12.4'}, {'value': '11.2', 'groupId': 'OG003', 'lowerLimit': '8.77', 'upperLimit': '14.2'}, {'value': '6.18', 'groupId': 'OG004', 'lowerLimit': '5.07', 'upperLimit': '7.53'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '17.2'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '8.75', 'upperLimit': '13.9'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '9.21', 'upperLimit': '15.3'}, {'value': '13.0', 'groupId': 'OG003', 'lowerLimit': '10.3', 'upperLimit': '16.4'}, {'value': '5.70', 'groupId': 'OG004', 'lowerLimit': '4.57', 'upperLimit': '7.12'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.97', 'groupId': 'OG000', 'lowerLimit': '6.41', 'upperLimit': '9.92'}, {'value': '8.44', 'groupId': 'OG001', 'lowerLimit': '6.88', 'upperLimit': '10.3'}, {'value': '8.20', 'groupId': 'OG002', 'lowerLimit': '6.54', 'upperLimit': '10.3'}, {'value': '1.26', 'groupId': 'OG003', 'lowerLimit': '1.11', 'upperLimit': '1.42'}, {'value': '13.9', 'groupId': 'OG004', 'lowerLimit': '11.5', 'upperLimit': '16.8'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.52', 'groupId': 'OG000', 'lowerLimit': '5.22', 'upperLimit': '8.14'}, {'value': '8.39', 'groupId': 'OG001', 'lowerLimit': '6.67', 'upperLimit': '10.5'}, {'value': '9.99', 'groupId': 'OG002', 'lowerLimit': '7.87', 'upperLimit': '12.7'}, {'value': '2.81', 'groupId': 'OG003', 'lowerLimit': '2.36', 'upperLimit': '3.35'}, {'value': '11.3', 'groupId': 'OG004', 'lowerLimit': '9.20', 'upperLimit': '13.8'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.45', 'groupId': 'OG000', 'lowerLimit': '6.74', 'upperLimit': '10.6'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.01', 'upperLimit': '12.6'}, {'value': '7.55', 'groupId': 'OG002', 'lowerLimit': '5.83', 'upperLimit': '9.78'}, {'value': '1.15', 'groupId': 'OG003', 'lowerLimit': '1.07', 'upperLimit': '1.22'}, {'value': '9.84', 'groupId': 'OG004', 'lowerLimit': '7.98', 'upperLimit': '12.1'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.57', 'groupId': 'OG000', 'lowerLimit': '4.56', 'upperLimit': '6.82'}, {'value': '6.13', 'groupId': 'OG001', 'lowerLimit': '5.08', 'upperLimit': '7.38'}, {'value': '5.36', 'groupId': 'OG002', 'lowerLimit': '4.36', 'upperLimit': '6.61'}, {'value': '1.18', 'groupId': 'OG003', 'lowerLimit': '1.10', 'upperLimit': '1.27'}, {'value': '5.54', 'groupId': 'OG004', 'lowerLimit': '4.65', 'upperLimit': '6.60'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.70', 'groupId': 'OG000', 'lowerLimit': '6.66', 'upperLimit': '11.4'}, {'value': '9.47', 'groupId': 'OG001', 'lowerLimit': '7.29', 'upperLimit': '12.3'}, {'value': '8.05', 'groupId': 'OG002', 'lowerLimit': '6.20', 'upperLimit': '10.5'}, {'value': '1.08', 'groupId': 'OG003', 'lowerLimit': '1.02', 'upperLimit': '1.14'}, {'value': '5.07', 'groupId': 'OG004', 'lowerLimit': '4.01', 'upperLimit': '6.40'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.77', 'groupId': 'OG000', 'lowerLimit': '6.28', 'upperLimit': '9.63'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '9.13', 'upperLimit': '14.7'}, {'value': '8.74', 'groupId': 'OG002', 'lowerLimit': '6.99', 'upperLimit': '10.9'}, {'value': '1.35', 'groupId': 'OG003', 'lowerLimit': '1.19', 'upperLimit': '1.52'}, {'value': '9.87', 'groupId': 'OG004', 'lowerLimit': '7.95', 'upperLimit': '12.2'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.21', 'groupId': 'OG000', 'lowerLimit': '7.38', 'upperLimit': '11.5'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.09', 'upperLimit': '12.5'}, {'value': '8.99', 'groupId': 'OG002', 'lowerLimit': '7.32', 'upperLimit': '11.0'}, {'value': '1.09', 'groupId': 'OG003', 'lowerLimit': '1.02', 'upperLimit': '1.17'}, {'value': '7.30', 'groupId': 'OG004', 'lowerLimit': '5.95', 'upperLimit': '8.95'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.54', 'groupId': 'OG000', 'lowerLimit': '3.68', 'upperLimit': '5.60'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.58', 'upperLimit': '6.81'}, {'value': '4.43', 'groupId': 'OG002', 'lowerLimit': '3.60', 'upperLimit': '5.45'}, {'value': '1.03', 'groupId': 'OG003', 'lowerLimit': '0.981', 'upperLimit': '1.08'}, {'value': '9.43', 'groupId': 'OG004', 'lowerLimit': '7.64', 'upperLimit': '11.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31', 'description': 'The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS was subset of the FAS. FAS included subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result (serotype specific IgG concentration or serotype specific OPA titer for at least one serotype). Only participants with data collected for each specified category are reported.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes post-vaccination', 'description': 'An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SafAS) included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 Days post-vaccination (Day 8)', 'description': 'A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}]}, {'title': 'Arthralgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}]}, {'title': 'Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 Days post-vaccination (Day 8)', 'description': 'A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Only those participants with data collected for each category at each specified timepoint are reported.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days post-vaccination', 'description': 'An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'OG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'OG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'OG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'OG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days', 'description': "An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS included participants who had received the study vaccine. All participants had their safety analyzed according to the vaccine they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single intramuscular (IM) injection of SP0202-IIb formulation at Day 1.'}, {'id': 'FG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'FG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'FG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'FG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '149'}, {'groupId': 'FG003', 'numSubjects': '149'}, {'groupId': 'FG004', 'numSubjects': '150'}]}, {'type': 'Safety Analysis Set (SafAS) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '148'}, {'groupId': 'FG003', 'numSubjects': '149'}, {'groupId': 'FG004', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '141'}, {'groupId': 'FG003', 'numSubjects': '147'}, {'groupId': 'FG004', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 17 investigational sites in United States between 08 Oct 2020 to 20 Jan 2022.', 'preAssignmentDetails': 'A total of 750 participants were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}, {'value': '150', 'groupId': 'BG004'}, {'value': '750', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: SP0202-IIb', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-IIb formulation at Day 1.'}, {'id': 'BG001', 'title': 'Group 2: SP0202-VI', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VI formulation at Day 1.'}, {'id': 'BG002', 'title': 'Group 3: SP0202-VII', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of SP0202-VII formulation at Day 1.'}, {'id': 'BG003', 'title': 'Group 4: Prevnar 13', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Prevnar 13 at Day 1.'}, {'id': 'BG004', 'title': 'Group 5: Pneumovax 23', 'description': 'Healthy participants aged 50 to 84 years who were naïve to previous pneumococcal vaccination received a single IM injection of Pneumovax 23 at Day 1.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '63.4', 'spread': '6.8', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '7.2', 'groupId': 'BG004'}, {'value': '63.2', 'spread': '6.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '417', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '333', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}, {'value': '604', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized population included all participants with data in the case report form (CRF).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-30', 'size': 783951, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-31T13:52', 'hasProtocol': True}, {'date': '2021-04-28', 'size': 728564, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-31T13:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2022-08-01', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2020-10-05', 'dispFirstSubmitQcDate': '2022-08-01', 'resultsFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2020-10-05', 'dispFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-07-31', 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA', 'timeFrame': 'Post-vaccination at Day 31', 'description': 'The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA', 'timeFrame': 'Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31', 'description': 'The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL', 'timeFrame': 'Post-vaccination at Day 31', 'description': 'The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.'}, {'measure': 'Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL', 'timeFrame': 'Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31', 'description': 'The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.'}, {'measure': 'Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)', 'timeFrame': 'Within 30 minutes post-vaccination', 'description': 'An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions', 'timeFrame': 'Up to 7 Days post-vaccination (Day 8)', 'description': 'A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.'}, {'measure': 'Number of Participants With Solicited Systemic Reactions', 'timeFrame': 'Up to 7 Days post-vaccination (Day 8)', 'description': 'A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.'}, {'measure': 'Number of Participants With Unsolicited AEs', 'timeFrame': 'Within 30 days post-vaccination', 'description': 'An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)', 'timeFrame': 'From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days', 'description': "An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Immunization']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25337&tenant=MT_SNY_9011', 'label': 'PSK00009 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination\n* Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23', 'detailedDescription': "The duration of each participant's participation was approximately 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n\\- Aged 50 to 84 years on the day of inclusion .\n\nExclusion criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, the female must have been post-menopausal for at least 1 year, or surgically sterile.\n* Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure.\n* Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV).\n* Received immune globulins, blood or blood-derived products in the past 3 months.\n* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* History of S. pneumoniae infection or disease, confirmed either serologically, or microbiologically.\n* History of Guillain-Barré syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine.\n* Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine \\< 10 years ago.\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances .\n* Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.\n* At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity).\n* Current alcohol abuse or drug addiction.\n* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.\n* Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 \\[COVID-19\\]).\n* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has subsided.\n* Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.\n* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04583618', 'briefTitle': 'Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years', 'orgStudyIdInfo': {'id': 'PSK00009'}, 'secondaryIdInfos': [{'id': 'U1111-1238-9824', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP0202-IIb', 'description': 'One dose at Day 1', 'interventionNames': ['Biological: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb']}, {'type': 'EXPERIMENTAL', 'label': 'SP0202-VI', 'description': 'One dose at Day 1', 'interventionNames': ['Biological: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI']}, {'type': 'EXPERIMENTAL', 'label': 'SP0202-VII', 'description': 'One dose at Day 1', 'interventionNames': ['Biological: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevnar 13', 'description': 'One dose at Day 1', 'interventionNames': ['Biological: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pneumovax 23', 'description': 'One dose at Day 1', 'interventionNames': ['Biological: Pneumococcal Vaccine Polyvalent-Pneumovax 23']}], 'interventions': [{'name': 'Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Suspension for injection Route of administration: intramuscular', 'armGroupLabels': ['SP0202-IIb']}, {'name': 'Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Suspension for injection Route of administration: intramuscular', 'armGroupLabels': ['SP0202-VI']}, {'name': 'Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Suspension for injection Route of administration: intramuscular', 'armGroupLabels': ['SP0202-VII']}, {'name': 'Pneumococcal 13 - valent conjugate vaccine-Prevnar 13', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Suspension for injection Route of administration: intramuscular', 'armGroupLabels': ['Prevnar 13']}, {'name': 'Pneumococcal Vaccine Polyvalent-Pneumovax 23', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Solution for injection Route of administration: intramuscular', 'armGroupLabels': ['Pneumovax 23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Emmaus Research Center, Inc Site Number : 8400014', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Research Associates Site Number : 8400012', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research Site Number : 8400016', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Associates, LLC Site Number : 8400017', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Advanced Clinical Research - Magic View Site Number : 8400003', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Velocity Clinical Research Valparaiso Site Number : 8400001', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Velocity Clinical Research Site Number : 8400005', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Be Well Clinical Studies Site Number : 8400018', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'WR-CRCN, LLC Site Number : 8400013', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Biotrial Inc Site Number : 8400006', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Plains Clinical Research Center, LLC Site Number : 8400011', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research Columbus Site Number : 8400007', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Velocity Clinical Research, Medford Site Number : 8400010', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians Site Number : 8400009', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29405', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center - N Charleston Site Number : 8400004', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research Site Number : 8400008', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}