Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT05489328
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.', 'description': 'The same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received the study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 25, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 27, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 21, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 28, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 30, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 30, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 22, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 32, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 37, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue (FATIGUE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 16}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 23}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site erythema (REDNESS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site pain (PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 29}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site swelling (SWELLING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pyrexia (FEVER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthralgia (JOINT PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myalgia (MUSCLE PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 13}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache (HEADACHE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 45, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 45, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 15}, {'groupId': 'EG008', 'numAtRisk': 46, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}], 'classes': [{'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '4.3', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '4.7', 'groupId': 'OG007', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '4.7', 'groupId': 'OG007', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '11.5'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '6.5', 'groupId': 'OG005', 'lowerLimit': '1.4', 'upperLimit': '17.9'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '4.7', 'groupId': 'OG007', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '8.7', 'groupId': 'OG008', 'lowerLimit': '2.4', 'upperLimit': '20.8'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '4.7', 'groupId': 'OG007', 'lowerLimit': '0.6', 'upperLimit': '15.8'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Pain At Injection Site: Mild', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '26.2'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '42.0'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '36.5'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '13.2', 'upperLimit': '40.3'}, {'value': '37.8', 'groupId': 'OG004', 'lowerLimit': '23.8', 'upperLimit': '53.5'}, {'value': '23.9', 'groupId': 'OG005', 'lowerLimit': '12.6', 'upperLimit': '38.8'}, {'value': '11.1', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '24.1'}, {'value': '37.2', 'groupId': 'OG007', 'lowerLimit': '23.0', 'upperLimit': '53.3'}, {'value': '54.3', 'groupId': 'OG008', 'lowerLimit': '39.0', 'upperLimit': '69.1'}]}]}, {'title': 'Pain At Injection Site: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '6.7', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '18.3'}, {'value': '17.4', 'groupId': 'OG005', 'lowerLimit': '7.8', 'upperLimit': '31.4'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '30.2', 'groupId': 'OG007', 'lowerLimit': '17.2', 'upperLimit': '46.1'}, {'value': '6.5', 'groupId': 'OG008', 'lowerLimit': '1.4', 'upperLimit': '17.9'}]}]}, {'title': 'Pain At Injection Site: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '11.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after study intervention', 'description': "Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\\>) 2.0 cm to 5.0 cm, moderate: \\>5.0 cm to 10.0 cm and severe \\> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received the study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}], 'classes': [{'title': 'Fever: >/=38.0 degrees C to 38.4 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '4.3', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '2.3', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '12.3'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '11.5'}]}]}, {'title': 'Fever: >38.4 degrees C to 38.9 degrees C', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '15.1'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '4.3', 'groupId': 'OG008', 'lowerLimit': '0.5', 'upperLimit': '14.8'}]}]}, {'title': 'Fever: >38.9 degrees C to 40.0 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Fever: >40.0 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '32.1'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '34.1'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '36.5'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '27.4'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '24.1'}, {'value': '21.7', 'groupId': 'OG005', 'lowerLimit': '10.9', 'upperLimit': '36.4'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '11.2', 'upperLimit': '37.1'}, {'value': '20.9', 'groupId': 'OG007', 'lowerLimit': '10.0', 'upperLimit': '36.0'}, {'value': '21.7', 'groupId': 'OG008', 'lowerLimit': '10.9', 'upperLimit': '36.4'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '29.2'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '42.0'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '13.2', 'upperLimit': '40.3'}, {'value': '31.1', 'groupId': 'OG004', 'lowerLimit': '18.2', 'upperLimit': '46.6'}, {'value': '19.6', 'groupId': 'OG005', 'lowerLimit': '9.4', 'upperLimit': '33.9'}, {'value': '11.1', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '24.1'}, {'value': '30.2', 'groupId': 'OG007', 'lowerLimit': '17.2', 'upperLimit': '46.1'}, {'value': '15.2', 'groupId': 'OG008', 'lowerLimit': '6.3', 'upperLimit': '28.9'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '4.5', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '15.1'}, {'value': '4.3', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '2.3', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '12.3'}, {'value': '8.7', 'groupId': 'OG008', 'lowerLimit': '2.4', 'upperLimit': '20.8'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '50.6'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '39.5'}, {'value': '25.6', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '42.1'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '32.7'}, {'value': '13.3', 'groupId': 'OG004', 'lowerLimit': '5.1', 'upperLimit': '26.8'}, {'value': '17.4', 'groupId': 'OG005', 'lowerLimit': '7.8', 'upperLimit': '31.4'}, {'value': '15.6', 'groupId': 'OG006', 'lowerLimit': '6.5', 'upperLimit': '29.5'}, {'value': '14.0', 'groupId': 'OG007', 'lowerLimit': '5.3', 'upperLimit': '27.9'}, {'value': '13.0', 'groupId': 'OG008', 'lowerLimit': '4.9', 'upperLimit': '26.3'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '19.9'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '25.6'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '20.0', 'groupId': 'OG004', 'lowerLimit': '9.6', 'upperLimit': '34.6'}, {'value': '6.5', 'groupId': 'OG005', 'lowerLimit': '1.4', 'upperLimit': '17.9'}, {'value': '6.7', 'groupId': 'OG006', 'lowerLimit': '1.4', 'upperLimit': '18.3'}, {'value': '14.0', 'groupId': 'OG007', 'lowerLimit': '5.3', 'upperLimit': '27.9'}, {'value': '10.9', 'groupId': 'OG008', 'lowerLimit': '3.6', 'upperLimit': '23.6'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '7.0', 'groupId': 'OG007', 'lowerLimit': '1.5', 'upperLimit': '19.1'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}, {'title': 'Muscle Pain: Mild', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '26.2'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '19.5'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '27.4'}, {'value': '8.9', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '21.2'}, {'value': '13.0', 'groupId': 'OG005', 'lowerLimit': '4.9', 'upperLimit': '26.3'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '11.6', 'groupId': 'OG007', 'lowerLimit': '3.9', 'upperLimit': '25.1'}, {'value': '17.4', 'groupId': 'OG008', 'lowerLimit': '7.8', 'upperLimit': '31.4'}]}]}, {'title': 'Muscle Pain: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '6.7', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '18.3'}, {'value': '13.0', 'groupId': 'OG005', 'lowerLimit': '4.9', 'upperLimit': '26.3'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '18.6', 'groupId': 'OG007', 'lowerLimit': '8.4', 'upperLimit': '33.4'}, {'value': '13.0', 'groupId': 'OG008', 'lowerLimit': '4.9', 'upperLimit': '26.3'}]}]}, {'title': 'Muscle Pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '4.3', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '4.3', 'groupId': 'OG008', 'lowerLimit': '0.5', 'upperLimit': '14.8'}]}]}, {'title': 'Joint Pain: Mild', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '22.6'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '6.7', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '18.3'}, {'value': '10.9', 'groupId': 'OG005', 'lowerLimit': '3.6', 'upperLimit': '23.6'}, {'value': '4.4', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '15.1'}, {'value': '11.6', 'groupId': 'OG007', 'lowerLimit': '3.9', 'upperLimit': '25.1'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '11.5'}]}]}, {'title': 'Joint Pain: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '16.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '15.1'}, {'value': '6.5', 'groupId': 'OG005', 'lowerLimit': '1.4', 'upperLimit': '17.9'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '9.3', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '22.1'}, {'value': '13.0', 'groupId': 'OG008', 'lowerLimit': '4.9', 'upperLimit': '26.3'}]}]}, {'title': 'Joint Pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '11.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after study intervention', 'description': "Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\\>=) 38.0 degrees Celsius (C) and categorized as \\>=38.0 to 38.4 degrees C, \\>38.4 to 38.9 degrees C, \\>38.9 to 40.0 degrees C and \\>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received the study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '16.2'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '8.9', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '21.2'}, {'value': '4.3', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '2.3', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '12.3'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '11.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after study intervention', 'description': 'An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received the study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}, {'value': '46', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '11.8'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '7.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after study intervention', 'description': 'An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - 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 and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received the study intervention.'}, {'type': 'SECONDARY', 'title': 'Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'OG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '328'}, {'value': '428', 'groupId': 'OG001', 'lowerLimit': '318', 'upperLimit': '575'}, {'value': '350', 'groupId': 'OG002', 'lowerLimit': '254', 'upperLimit': '481'}, {'value': '354', 'groupId': 'OG003', 'lowerLimit': '271', 'upperLimit': '461'}, {'value': '324', 'groupId': 'OG004', 'lowerLimit': '239', 'upperLimit': '439'}, {'value': '536', 'groupId': 'OG005', 'lowerLimit': '372', 'upperLimit': '774'}, {'value': '168', 'groupId': 'OG006', 'lowerLimit': '116', 'upperLimit': '244'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after study intervention', 'description': "GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).", 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population included eligible participants who received study intervention as randomized, had at least 1 valid assay result within 27 to 49 days after administration, and had no major protocol deviations. Participants from each candidate and candidate control group were included as per the protocol specified objective. Number of Participants Analyzed= participants in evaluable immunogenicity population \\& had valid result 1 month after study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'FG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who were randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '47'}, {'groupId': 'FG007', 'numSubjects': '44'}, {'groupId': 'FG008', 'numSubjects': '47'}]}, {'type': 'Vaccinated', 'comment': 'Participants who were administered the study intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'comment': 'One participant received Candidate-4.', 'groupId': 'FG006', 'numSubjects': '46'}, {'groupId': 'FG007', 'numSubjects': '43'}, {'groupId': 'FG008', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '46'}, {'groupId': 'FG007', 'numSubjects': '41'}, {'groupId': 'FG008', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 17 sites in the United States.', 'preAssignmentDetails': 'A total of 394 participants were enrolled and randomized in the study of which 3 participants were not vaccinated and, 391 were administered study intervention. One participant randomized to Candidate-Control received Candidate-4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}, {'value': '43', 'groupId': 'BG007'}, {'value': '46', 'groupId': 'BG008'}, {'value': '391', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Candidate-1', 'description': 'Participants were administered a single intramuscular injection of candidate-1 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG001', 'title': 'Candidate-2', 'description': 'Participants were administered a single intramuscular injection of candidate-2 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG002', 'title': 'Candidate-3', 'description': 'Participants were administered a single intramuscular injection of candidate-3 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG003', 'title': 'Candidate-4', 'description': 'Participants were administered a single intramuscular injection of candidate-4 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG004', 'title': 'Candidate-5', 'description': 'Participants were administered a single intramuscular injection of candidate-5 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG005', 'title': 'Candidate-6', 'description': 'Participants were administered a single intramuscular injection of candidate-6 on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG006', 'title': 'Candidate - Control', 'description': 'Participants were administered a single intramuscular injection of control on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG007', 'title': 'PCV15', 'description': 'Participants were administered a single intramuscular injection of pneumococcal 15-valent conjugate (PCV15) vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG008', 'title': '13vPnC', 'description': 'Participants were administered a single intramuscular injection of Prevnar 13 vaccine (control) on Day 1. Participants were followed up for 1 month (28-42 days) after administration of study intervention.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '9.15', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '9.11', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '9.44', 'groupId': 'BG002'}, {'value': '33.2', 'spread': '9.39', 'groupId': 'BG003'}, {'value': '33.3', 'spread': '9.29', 'groupId': 'BG004'}, {'value': '35.2', 'spread': '8.35', 'groupId': 'BG005'}, {'value': '34.1', 'spread': '7.68', 'groupId': 'BG006'}, {'value': '35.6', 'spread': '8.86', 'groupId': 'BG007'}, {'value': '35.7', 'spread': '7.38', 'groupId': 'BG008'}, {'value': '34.8', 'spread': '8.71', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '227', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '164', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '128', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}, {'value': '262', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '69', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}, {'value': '32', 'groupId': 'BG008'}, {'value': '286', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on safety population which included all participants who received the study intervention. Participants were summarized according to the study intervention they received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-26', 'size': 906652, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-28T09:51', 'hasProtocol': True}, {'date': '2022-12-05', 'size': 455170, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-28T11:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2022-08-03', 'resultsFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-16', 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention', 'timeFrame': 'Within 7 days after study intervention', 'description': "Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\\>) 2.0 cm to 5.0 cm, moderate: \\>5.0 cm to 10.0 cm and severe \\> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method."}, {'measure': 'Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention', 'timeFrame': 'Within 7 days after study intervention', 'description': "Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\\>=) 38.0 degrees Celsius (C) and categorized as \\>=38.0 to 38.4 degrees C, \\>38.4 to 38.9 degrees C, \\>38.9 to 40.0 degrees C and \\>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method."}, {'measure': 'Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention', 'timeFrame': 'Within 1 month after study intervention', 'description': 'An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention', 'timeFrame': 'Within 1 month after study intervention', 'description': 'An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - 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 and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.'}], 'secondaryOutcomes': [{'measure': 'Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group', 'timeFrame': '1 month after study intervention', 'description': "GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4801001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants ≥18 and ≤49 years of age at the time of consent\n* Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention\n* Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children\n\nExclusion Criteria:\n\n* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine\n* Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study\n* Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study\n* Known or suspected immunodeficiency or other conditions associated with immunosuppression\n* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation\n* Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention"}, 'identificationModule': {'nctId': 'NCT05489328', 'briefTitle': 'Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'C4801001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candidate-1', 'description': 'Participants to receive a single injection of Candidate-1.', 'interventionNames': ['Other: Candidate-1']}, {'type': 'EXPERIMENTAL', 'label': 'Candidate-2', 'description': 'Participants to receive a single injection of Candidate-2.', 'interventionNames': ['Other: Candidate-2']}, {'type': 'EXPERIMENTAL', 'label': 'Candidate-3', 'description': 'Participants to receive a single injection of Candidate-3.', 'interventionNames': ['Other: Candidate-3']}, {'type': 'EXPERIMENTAL', 'label': 'Candidate-4', 'description': 'Participants to receive a single injection of Candidate-4.', 'interventionNames': ['Other: Candidate-4']}, {'type': 'EXPERIMENTAL', 'label': 'Candidate-5', 'description': 'Participants to receive a single injection of Candidate-5.', 'interventionNames': ['Other: Candidate-5']}, {'type': 'EXPERIMENTAL', 'label': 'Candidate-6', 'description': 'Participants to receive a single injection of Candidate-6.', 'interventionNames': ['Other: Candidate-6']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Candidate Control', 'description': 'Participants to receive a single injection of Candidate Control.', 'interventionNames': ['Other: Candidate Control']}, {'type': 'OTHER', 'label': '13-valent pneumococcal conjugate vaccine (13vPnC)', 'description': 'Participants to receive a single injection of 13vPnC.', 'interventionNames': ['Biological: 13vPnC']}, {'type': 'OTHER', 'label': '15-valent pneumococcal conjugate vaccine (PCV15)', 'description': 'Participants to receive a single injection of PCV15.', 'interventionNames': ['Biological: PCV15']}], 'interventions': [{'name': 'Candidate-1', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate-1']}, {'name': 'Candidate-2', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate-2']}, {'name': 'Candidate-3', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate-3']}, {'name': 'Candidate-4', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate-4']}, {'name': 'Candidate-5', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate-5']}, {'name': 'Candidate-6', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate-6']}, {'name': 'Candidate Control', 'type': 'OTHER', 'description': 'Biological', 'armGroupLabels': ['Candidate Control']}, {'name': '13vPnC', 'type': 'BIOLOGICAL', 'description': '13-valent pneumococcal conjugate vaccine', 'armGroupLabels': ['13-valent pneumococcal conjugate vaccine (13vPnC)']}, {'name': 'PCV15', 'type': 'BIOLOGICAL', 'description': '15-valent pneumococcal conjugate vaccine', 'armGroupLabels': ['15-valent pneumococcal conjugate vaccine (PCV15)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06460', 'city': 'Milford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Clinical Research Consulting', 'geoPoint': {'lat': 41.22232, 'lon': -73.0565}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Proactive Clinical Research,LLC', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centennial Medical Group', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcturus Healthcare , PLC, Troy Internal Medicine Research Division', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research LLC dba Nucleus Network', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Infectious Disease', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Accellacare - Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diagnostics Research Group', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'IMA Clinical Research San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}