Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT03313050
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2017-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D011134', 'term': 'Polysaccharides'}], 'ancestors': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, '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: within 14 days after vaccination; Non serious AEs: Stage 1 and 2- baseline up to 1 month after vaccination (approximately up to 35 days); SAEs: Stage 1- baseline up to 6 months after vaccination (approximately up to 196 days), Stage 2- baseline up to 12 months after vaccination (approximately up to 378 days)', 'description': 'Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 27, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 28, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 161, 'seriousNumAtRisk': 221, 'deathsNumAffected': 3, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 171, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 104}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 107}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 136}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'seriousEvents': [{'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Spinal synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hernia hiatus repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '29.0'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '20.8'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '20.8'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '36.4'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '20.8'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '29.0'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Pain at injection site: Any', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '46.5', 'upperLimit': '80.3'}, {'value': '71.9', 'groupId': 'OG001', 'lowerLimit': '53.3', 'upperLimit': '86.3'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '67.6'}, {'value': '59.4', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '76.3'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '31.1'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '29.0'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 14 days after vaccination', 'description': 'Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\\>) 2.0 to 5.0 cm, moderate: \\>5.0 to 10.0 cm and severe: \\>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '12.6'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '23.6'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '9.8'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '12.5'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.2'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '8.1'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '9.2'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '10.9'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '22.1'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '9.8'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '9.2'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.2'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '11.9'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.9'}]}]}, {'title': 'Pain at injection site: Any', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '55.2'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '67.4'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000', 'lowerLimit': '39.9', 'upperLimit': '53.4'}, {'value': '44.8', 'groupId': 'OG001', 'lowerLimit': '38.2', 'upperLimit': '51.6'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.6'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '19.6'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 14 days after vaccination', 'description': 'Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \\>2.0 to 5.0 cm, moderate: \\>5.0 to 10.0 cm and severe: \\>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'title': 'Fever: >=38.0 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Fever: >=38.0 to 38.4 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Fever: >38.4 to 38.9 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Fever: >38.9 to 40.0 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Fever: >40.0 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '47.5'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '46.7'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '47.5'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '25.0'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '36.4'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '56.4'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '53.2'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '41.2'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '36.4'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '31.1'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '32.8'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '56.4'}, {'value': '56.3', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '73.6'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '44.4'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '62.3'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '29.0'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '32.8'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '27.5'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '29.0'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '16.2'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 14 days after vaccination', 'description': 'Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \\>=38.0 degrees Celsius (C), \\>=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 any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'title': 'Fever: >=38.0 degree C', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.2'}]}]}, {'title': 'Fever: >=38.0 to 38.4 degree C', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}, {'title': 'Fever: >38.4 to 38.9 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fever: >38.9 to 40.0 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fever: >40.0 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000', 'lowerLimit': '28.1', 'upperLimit': '41.1'}, {'value': '33.2', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '39.8'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '31.1'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '23.1'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '12.0'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '19.1'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.6'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.5'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '30.6'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '26.1'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '26.3'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '19.6'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.0'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '9.2'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '32.0', 'upperLimit': '45.2'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '39.9', 'upperLimit': '53.4'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '38.2'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '35.6'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '10.4'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '22.1'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.2'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '20.3'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '25.6'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '14.2'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '17.6'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '9.3'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '11.4'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 14 days after vaccination', 'description': 'Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \\>=38.0 degrees C, \\>=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 any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '25.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 1 month after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '14.7'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '18.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 1 month after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.2'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.3'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '20.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months after vaccination', 'description': 'An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '6.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '8.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months after vaccination', 'description': 'An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '7.6'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 12 months after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '10.9'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '10.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 12 months after vaccination', 'description': 'An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1401', 'groupId': 'OG000', 'lowerLimit': '913.4', 'upperLimit': '2147.9'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '26.4'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6622', 'groupId': 'OG000', 'lowerLimit': '3705.5', 'upperLimit': '11833.0'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '239.3'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3154', 'groupId': 'OG000', 'lowerLimit': '1890.7', 'upperLimit': '5262.8'}, {'value': '604', 'groupId': 'OG001', 'lowerLimit': '302.2', 'upperLimit': '1206.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9558', 'groupId': 'OG000', 'lowerLimit': '4114.7', 'upperLimit': '22202.0'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': '202.8'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3926', 'groupId': 'OG000', 'lowerLimit': '1526.1', 'upperLimit': '10100.2'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '49.7'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5932', 'groupId': 'OG000', 'lowerLimit': '3625.8', 'upperLimit': '9705.6'}, {'value': '167', 'groupId': 'OG001', 'lowerLimit': '74.4', 'upperLimit': '374.3'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8432', 'groupId': 'OG000', 'lowerLimit': '4116.7', 'upperLimit': '17271.3'}, {'value': '433', 'groupId': 'OG001', 'lowerLimit': '204.7', 'upperLimit': '915.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after vaccination', 'description': 'Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\\*LLOQ in the analysis. Evaluable immunogenicity population = EIP.', 'unitOfMeasure': 'Titer (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. 'Number Analyzed' = participants evaluable for this outcome measure at specified rows."}, {'type': 'SECONDARY', 'title': 'Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '528', 'groupId': 'OG000', 'lowerLimit': '423.2', 'upperLimit': '658.6'}, {'value': '639', 'groupId': 'OG001', 'lowerLimit': '511.9', 'upperLimit': '798.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2297', 'groupId': 'OG000', 'lowerLimit': '1842.9', 'upperLimit': '2863.4'}, {'value': '1052', 'groupId': 'OG001', 'lowerLimit': '802.5', 'upperLimit': '1378.9'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2290', 'groupId': 'OG000', 'lowerLimit': '1854.0', 'upperLimit': '2828.7'}, {'value': '2673', 'groupId': 'OG001', 'lowerLimit': '2182.7', 'upperLimit': '3274.6'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3684', 'groupId': 'OG000', 'lowerLimit': '2926.5', 'upperLimit': '4638.6'}, {'value': '2416', 'groupId': 'OG001', 'lowerLimit': '1852.8', 'upperLimit': '3151.0'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1381', 'groupId': 'OG000', 'lowerLimit': '1019.2', 'upperLimit': '1872.2'}, {'value': '586', 'groupId': 'OG001', 'lowerLimit': '426.0', 'upperLimit': '807.2'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4775', 'groupId': 'OG000', 'lowerLimit': '3889.1', 'upperLimit': '5862.2'}, {'value': '2723', 'groupId': 'OG001', 'lowerLimit': '2123.9', 'upperLimit': '3491.1'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4250', 'groupId': 'OG000', 'lowerLimit': '3403.2', 'upperLimit': '5307.2'}, {'value': '4043', 'groupId': 'OG001', 'lowerLimit': '3082.4', 'upperLimit': '5304.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'within 1 month after vaccination', 'description': 'Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\\*LLOQ in the analysis.', 'unitOfMeasure': 'Titer (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows."}, {'type': 'SECONDARY', 'title': 'Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.2', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '198.9'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '28.5', 'upperLimit': '146.9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.7'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '14.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.5'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '261.8', 'groupId': 'OG000', 'lowerLimit': '106.1', 'upperLimit': '646.2'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.4'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.2', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '312.7'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.3'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '137.3'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.8'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '74.6'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'before Vaccination to 1 month after Vaccination', 'description': 'GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\\*LLOQ in the analysis.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "EIP Stage 1:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows."}, {'type': 'SECONDARY', 'title': 'Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'OG001', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '39.6'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '53.8'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '43.8'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '20.9'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '10.1'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '9.4'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '86.8'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '52.0'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '44.4'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '23.0'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '42.7'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '25.9'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '14.2'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '11.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'before Vaccination to 1 month after Vaccination', 'description': 'GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\\*LLOQ in the analysis.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "EIP Stage 2:eligible participants with no major protocol deviations, received assigned vaccine, blood collected was within 27-49 days post vaccination, had at least 1 valid and determinate assay result for at least 1 serotype for 1 month after vaccination. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified rows."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'FG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'FG002', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'FG003', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}], 'periods': [{'title': 'Stage 1: 6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Stage 2: 12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Stage 1 participants did not continue in Stage 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Stage 1 participants did not continue in Stage 2.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'After Stage 1 safety was acceptable then Stage 2 followed with newer participants.', 'groupId': 'FG002', 'numSubjects': '221'}, {'comment': 'After Stage 1 safety was acceptable then Stage 2 followed with newer participants.', 'groupId': 'FG003', 'numSubjects': '224'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '221'}, {'groupId': 'FG003', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '210'}, {'groupId': 'FG003', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'No Longer Meets Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}, {'value': '510', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: c7vPnC (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'BG001', 'title': 'Stage 1: Tdap (50 to 64 Years of Age)', 'description': 'In Stage 1, healthy participants aged 50 to 64 years were randomized to receive a single 0.5 mL intramuscular injection of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as control vaccine on Day 1. Participants were followed up to 6 months after vaccination.'}, {'id': 'BG002', 'title': 'Stage 2: c7vPnC (65 to 85 Years of Age)', 'description': 'In Stage 2 healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of c7vPnC on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'BG003', 'title': 'Stage 2: PPSV23 (65 to 85 Years of Age)', 'description': 'In Stage 2, healthy participants aged 65 to 85 years, previously vaccinated with Prevnar 13, were randomized to receive a single 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23 ) as control vaccine on Day 1 of Stage 2. Participants were followed up to 12 months after vaccination.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '4.52', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '4.46', 'groupId': 'BG001'}, {'value': '68.9', 'spread': '4.72', 'groupId': 'BG002'}, {'value': '68.8', 'spread': '3.97', 'groupId': 'BG003'}, {'value': '67.5', 'spread': '5.66', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}, {'value': '310', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '200', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}, {'value': '493', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}, {'value': '479', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety population included all participants who received at least 1 dose of c7vPnC or Tdap or PPSV23 in the study and had post-vaccination follow-up and participants who lacked any safety data were excluded from the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-28', 'size': 2615676, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-15T13:19', 'hasProtocol': True}, {'date': '2018-01-30', 'size': 2347324, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-15T13:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Observer-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2017-10-10', 'resultsFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-15', 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination', 'timeFrame': 'within 14 days after vaccination', 'description': 'Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\\>) 2.0 to 5.0 cm, moderate: \\>5.0 to 10.0 cm and severe: \\>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.'}, {'measure': 'Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination', 'timeFrame': 'within 14 days after vaccination', 'description': 'Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \\>2.0 to 5.0 cm, moderate: \\>5.0 to 10.0 cm and severe: \\>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.'}, {'measure': 'Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination', 'timeFrame': 'within 14 days after vaccination', 'description': 'Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \\>=38.0 degrees Celsius (C), \\>=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 any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.'}, {'measure': 'Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination', 'timeFrame': 'within 14 days after vaccination', 'description': 'Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \\>=38.0 degrees C, \\>=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 any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.'}, {'measure': 'Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'timeFrame': 'within 1 month after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.'}, {'measure': 'Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination', 'timeFrame': 'within 1 month after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.'}, {'measure': 'Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination', 'timeFrame': 'within 6 months after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination', 'timeFrame': 'within 6 months after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination', 'timeFrame': 'within 6 months after vaccination', 'description': 'An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.'}, {'measure': 'Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination', 'timeFrame': 'within 6 months after vaccination', 'description': 'An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.'}, {'measure': 'Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination', 'timeFrame': 'within 12 months after vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination', 'timeFrame': 'within 12 months after vaccination', 'description': 'An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.'}], 'secondaryOutcomes': [{'measure': 'Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination', 'timeFrame': '1 month after vaccination', 'description': 'Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\\*LLOQ in the analysis. Evaluable immunogenicity population = EIP.'}, {'measure': 'Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination', 'timeFrame': 'within 1 month after vaccination', 'description': 'Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\\*LLOQ in the analysis.'}, {'measure': 'Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination', 'timeFrame': 'before Vaccination to 1 month after Vaccination', 'description': 'GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\\*LLOQ in the analysis.'}, {'measure': 'Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination', 'timeFrame': 'before Vaccination to 1 month after Vaccination', 'description': 'GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5\\*LLOQ in the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '33661716', 'type': 'DERIVED', 'citation': 'Essink B, Peterson J, Yacisin K, Lal H, Mirza S, Xu X, Scully IL, Scott DA, Gruber WC, Jansen KU, Watson W. A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age. Hum Vaccin Immunother. 2021 Aug 3;17(8):2691-2699. doi: 10.1080/21645515.2021.1890511. Epub 2021 Mar 4.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3571001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.\n\nIn Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).\n\nIn Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \\>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination\n* Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 \\>= 2 months prior to investigational product administration\n\nExclusion Criteria:\n\n* Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine\n* Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13'}, 'identificationModule': {'nctId': 'NCT03313050', 'briefTitle': 'A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'C3571001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1 multivalent (ages 50-64 years)', 'description': 'multivalent', 'interventionNames': ['Biological: Multivalent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 1 Tdap (ages 50-64 years)', 'description': 'Tdap', 'interventionNames': ['Biological: Tdap']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2 multivalent (ages 65-85 years)', 'description': 'multivalent', 'interventionNames': ['Biological: Multivalent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stage 2 polysaccharide (ages 65-85 years)', 'description': 'polysaccharide', 'interventionNames': ['Biological: polysaccharide']}], 'interventions': [{'name': 'Multivalent', 'type': 'BIOLOGICAL', 'description': 'Pneumococcal conjugate vaccine', 'armGroupLabels': ['Stage 1 multivalent (ages 50-64 years)', 'Stage 2 multivalent (ages 65-85 years)']}, {'name': 'Tdap', 'type': 'BIOLOGICAL', 'description': 'Tetanus, diphtheria, acellular pertussis vaccine', 'armGroupLabels': ['Stage 1 Tdap (ages 50-64 years)']}, {'name': 'polysaccharide', 'type': 'BIOLOGICAL', 'description': '23-valent pneumococcal polysaccharide vaccine', 'armGroupLabels': ['Stage 2 polysaccharide (ages 65-85 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Core Healthcare Group', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '67010', 'city': 'Augusta', 'state': 'Kansas', 'country': 'United States', 'facility': 'Augusta Family Practice', 'geoPoint': {'lat': 37.68668, 'lon': -96.9767}}, {'zip': '67010', 'city': 'Augusta', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 37.68668, 'lon': -96.9767}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Axtell Clinic, P.A.', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatric/Adult Research', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Charlotte, LLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington, LLC', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Omega Medical Research', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29445', 'city': 'Goose Creek', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical Research South, LLC', 'geoPoint': {'lat': 32.98101, 'lon': -80.03259}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research Incorporated, 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, Incorporated/Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', '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'}}}}