Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 1:35 AM
Study NCT ID:
NCT04875533
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2021-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}}}, '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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_lnquiries@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': 'SAEs, non-serious AEs (NSAEs), and deaths were reported from Vaccination 1 (Day 1) to 28-42 days after Vaccination 1 and Vaccination 2 to 28-42 days after Vaccination 2 from all participants. The e-diary was collected 10 days for local reactions and 7 days for systemic events after Vaccination 1 for all participants, and after Vaccination 2 for Japan participants only.', 'description': 'Same event may appear as NSAE and SAE, what is presented are distinct events. Event may be categorized as SAE in 1 participant and as NSAE in another participant or 1 participant may have experienced both SAE and NSAE during study. Participants received 20vPnC followed by saline in the 20vPnC/saline group or 13vPnC followed by PPSV23 in the 13vPnC/PPSV23 group. Results were summarized by the 1-month time period following vaccination 1 or vaccination 2 for each group using the safety population.', 'eventGroups': [{'id': 'EG000', 'title': '20vPnC/Saline (Vaccination 1)', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1)', 'otherNumAtRisk': 711, 'deathsNumAtRisk': 711, 'otherNumAffected': 448, 'seriousNumAtRisk': 711, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '13vPnC/PPSV23 (Vaccination 1)', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1).', 'otherNumAtRisk': 710, 'deathsNumAtRisk': 710, 'otherNumAffected': 439, 'seriousNumAtRisk': 710, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': '20vPnC/Saline (Vaccination 2)', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).', 'otherNumAtRisk': 695, 'deathsNumAtRisk': 695, 'otherNumAffected': 78, 'seriousNumAtRisk': 695, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': '13vPnC/PPSV23 (Vaccination 2)', 'description': 'Participants aged 60 years and above received a single dose of 0.5mL PPSV23 intramuscularly at Vaccination 2 (28 to 42 Days after Vaccination 1).', 'otherNumAtRisk': 699, 'deathsNumAtRisk': 699, 'otherNumAffected': 333, 'seriousNumAtRisk': 699, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue (FATIGUE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 163}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site erythema (REDNESS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site pain (PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 371}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 360}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 302}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site swelling (SWELLING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Arthralgia (JOINT PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Myalgia (MUSCLE PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 127}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 105}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Headache (HEADACHE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 711, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 695, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 699, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '710', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Redness-Any', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '15.0'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '12.1'}]}]}, {'title': 'Redness-Mild', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '8.2'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '6.3'}]}]}, {'title': 'Redness-Moderate', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '6.6'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '5.6'}]}]}, {'title': 'Redness-Severe', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '2.6'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '2.4'}]}]}, {'title': 'Swelling-Any', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '12.9'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '9.7'}]}]}, {'title': 'Swelling-Mild', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '7.3'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '5.2'}]}]}, {'title': 'Swelling-Moderate', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '6.3'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.7'}]}]}, {'title': 'Swelling-Severe', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.8'}]}]}, {'title': 'Pain at the injection site-Any', 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '48.5', 'upperLimit': '56.0'}, {'value': '50.7', 'groupId': 'OG001', 'lowerLimit': '47.0', 'upperLimit': '54.4'}]}]}, {'title': 'Pain at the injection site-Mild', 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '49.4'}, {'value': '46.3', 'groupId': 'OG001', 'lowerLimit': '42.6', 'upperLimit': '50.1'}]}]}, {'title': 'Pain at the injection site-Moderate', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '8.5'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '5.8'}]}]}, {'title': 'Pain at the injection site-Severe', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'Reactions were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nRedness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm), and severe (\\>10.0 cm).\n\nPain at the injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed"=number of participants with any e-diary data reported after 20vPnC or 13vPnC.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '710', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Fever ≥38.0°C', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.4'}]}]}, {'title': 'Fever ≥38.0°C to 38.4°C', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Fever >38.4°C to 38.9°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}, {'title': 'Fever >38.9°C to 40.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}, {'title': 'Fever >40.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Fatigue-Any', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '23.9'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '26.2'}]}]}, {'title': 'Fatigue-Mild', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '21.1'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '21.9'}]}]}, {'title': 'Fatigue-Moderate', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.1'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '5.5'}]}]}, {'title': 'Fatigue-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Headache-Any', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '11.5'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '13.5'}]}]}, {'title': 'Headache-Mild', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '10.4'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '12.0'}]}]}, {'title': 'Headache-Moderate', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.0'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.2'}]}]}, {'title': 'Headache-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Muscle pain-Any', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '20.6'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '20.9'}]}]}, {'title': 'Muscle pain-Mild', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '18.1'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '17.6'}]}]}, {'title': 'Muscle pain-Moderate', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.6'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.5'}]}]}, {'title': 'Muscle pain-Severe', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}, {'title': 'Joint pain-Any', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '8.9'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '10.1'}]}]}, {'title': 'Joint pain-Mild', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '7.1'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '7.9'}]}]}, {'title': 'Joint pain-Moderate', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '2.8'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '3.3'}]}]}, {'title': 'Joint pain-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'Events were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nFever was categorized as ≥38.0 degree Celsius (°C), ≥38.0°C to 38.4°C, \\>38.4°C to 38.9°C, \\>38.9°C to 40.0°C, and \\>40.0°C.\n\nFatigue, headache, muscle pain, and joint pain were graded as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed" is number of participants with any e-diary data reported after 20vPnC or 13vPnC.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '7.6'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '7.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.2'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'description': 'An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination.'}, {'type': 'PRIMARY', 'title': 'Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '688', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000', 'lowerLimit': '177', 'upperLimit': '242'}, {'value': '267', 'groupId': 'OG001', 'lowerLimit': '229', 'upperLimit': '311'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '55'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '62'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '813', 'groupId': 'OG000', 'lowerLimit': '696', 'upperLimit': '949'}, {'value': '1029', 'groupId': 'OG001', 'lowerLimit': '881', 'upperLimit': '1202'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '112'}, {'value': '125', 'groupId': 'OG001', 'lowerLimit': '107', 'upperLimit': '145'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1286', 'groupId': 'OG000', 'lowerLimit': '1088', 'upperLimit': '1520'}, {'value': '1475', 'groupId': 'OG001', 'lowerLimit': '1249', 'upperLimit': '1742'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '668', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1399', 'groupId': 'OG000', 'lowerLimit': '1196', 'upperLimit': '1637'}, {'value': '1537', 'groupId': 'OG001', 'lowerLimit': '1314', 'upperLimit': '1798'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1735', 'groupId': 'OG000', 'lowerLimit': '1578', 'upperLimit': '1907'}, {'value': '2076', 'groupId': 'OG001', 'lowerLimit': '1889', 'upperLimit': '2282'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '681', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1467', 'groupId': 'OG000', 'lowerLimit': '1285', 'upperLimit': '1674'}, {'value': '1663', 'groupId': 'OG001', 'lowerLimit': '1459', 'upperLimit': '1895'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '704', 'groupId': 'OG000', 'lowerLimit': '602', 'upperLimit': '824'}, {'value': '647', 'groupId': 'OG001', 'lowerLimit': '554', 'upperLimit': '756'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1325', 'groupId': 'OG000', 'lowerLimit': '1142', 'upperLimit': '1538'}, {'value': '1826', 'groupId': 'OG001', 'lowerLimit': '1575', 'upperLimit': '2117'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '864', 'groupId': 'OG000', 'lowerLimit': '750', 'upperLimit': '994'}, {'value': '1172', 'groupId': 'OG001', 'lowerLimit': '1018', 'upperLimit': '1349'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '683', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000', 'lowerLimit': '310', 'upperLimit': '431'}, {'value': '574', 'groupId': 'OG001', 'lowerLimit': '487', 'upperLimit': '676'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000', 'lowerLimit': '239', 'upperLimit': '351'}, {'value': '361', 'groupId': 'OG001', 'lowerLimit': '298', 'upperLimit': '437'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.92', 'groupDescription': 'Serotype 1: the ratio of GMT (GMR) (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.79', 'ciUpperLimit': '0.99', 'groupDescription': 'Serotype 3: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.94', 'groupDescription': 'Serotype 4: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.91', 'groupDescription': 'Serotype 5: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.05', 'groupDescription': 'Serotype 6A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.08', 'groupDescription': 'Serotype 6B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.93', 'groupDescription': 'Serotype 7F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.02', 'groupDescription': 'Serotype 9V: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.29', 'groupDescription': 'Serotype 14: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.85', 'groupDescription': 'Serotype 18C: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.86', 'groupDescription': 'Serotype 19A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.76', 'groupDescription': 'Serotype 19F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/13vPnC)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.99', 'groupDescription': 'Serotype 23F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'OPA titers were determined for the 13 matching pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. GMTs and 2-sided CIs were calculated by exponentiating the Least Square (LS) means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations (PDs). Number Analyzed=participants evaluable for this outcome measure (OM) at specified row.'}, {'type': 'PRIMARY', 'title': 'Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '689', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '561', 'groupId': 'OG000', 'lowerLimit': '490', 'upperLimit': '642'}, {'value': '971', 'groupId': 'OG001', 'lowerLimit': '850', 'upperLimit': '1110'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1661', 'groupId': 'OG000', 'lowerLimit': '1422', 'upperLimit': '1939'}, {'value': '777', 'groupId': 'OG001', 'lowerLimit': '667', 'upperLimit': '906'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3331', 'groupId': 'OG000', 'lowerLimit': '2834', 'upperLimit': '3913'}, {'value': '1933', 'groupId': 'OG001', 'lowerLimit': '1644', 'upperLimit': '2274'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3543', 'groupId': 'OG000', 'lowerLimit': '2976', 'upperLimit': '4217'}, {'value': '2104', 'groupId': 'OG001', 'lowerLimit': '1766', 'upperLimit': '2507'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1265', 'groupId': 'OG000', 'lowerLimit': '1039', 'upperLimit': '1539'}, {'value': '593', 'groupId': 'OG001', 'lowerLimit': '487', 'upperLimit': '723'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2818', 'groupId': 'OG000', 'lowerLimit': '2345', 'upperLimit': '3388'}, {'value': '1737', 'groupId': 'OG001', 'lowerLimit': '1445', 'upperLimit': '2089'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6675', 'groupId': 'OG000', 'lowerLimit': '5751', 'upperLimit': '7748'}, {'value': '5853', 'groupId': 'OG001', 'lowerLimit': '5046', 'upperLimit': '6788'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.67', 'groupDescription': 'Serotype 8: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.14', 'ciLowerLimit': '1.80', 'ciUpperLimit': '2.53', 'groupDescription': 'Serotype 10A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '1.44', 'ciUpperLimit': '2.06', 'groupDescription': 'Serotype 11A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.39', 'ciUpperLimit': '2.04', 'groupDescription': 'Serotype 12F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '1.72', 'ciUpperLimit': '2.64', 'groupDescription': 'Serotype 15B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.33', 'ciUpperLimit': '1.98', 'groupDescription': 'Serotype 22F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs (20vPnC/PPSV23)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.34', 'groupDescription': 'Serotype 33F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after 20vPnC in the 20vPnC/Saline group or 1 month after PPSV23 in the 13vPnC/PPSV23 group.', 'description': 'OPA titers were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype) included participants who were enrolled, received 20vPnC in the 20vPnC/saline group or received both vaccinations in the 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or 2 respectively, had no other major PDs. Number Analyzed=participants evaluable for this OM at specified row.'}, {'type': 'SECONDARY', 'title': 'OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '14.9'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '18.7'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '680', 'groupId': 'OG000'}, {'value': '679', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '5.3'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '5.9'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}, {'value': '661', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '34.9'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '30.5', 'upperLimit': '41.7'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '6.0'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '7.8'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '672', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '28.3'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '31.6'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '17.3'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '18.4'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}, {'value': '636', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '6.6'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '7.9'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '8.0'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.5'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '10.0'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '9.0'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '21.5'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '28.5'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '27.8'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '34.8'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '674', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '10.2'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '15.6'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '22.0'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '26.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group.', 'description': "GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.", 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major PDs. Number analyzed in each row=participants evaluable with OPA titers available at both timepoints at specified serotype.'}, {'type': 'SECONDARY', 'title': 'OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '689', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '20.3'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '34.4'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}, {'value': '633', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '15.1'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '7.0'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '17.1'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '8.5'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '602', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '81.1'}, {'value': '38.2', 'groupId': 'OG001', 'lowerLimit': '32.2', 'upperLimit': '45.3'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '637', 'groupId': 'OG000'}, {'value': '632', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000', 'lowerLimit': '21.7', 'upperLimit': '31.0'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '14.0'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '50.5'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '27.9'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '623', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '8.5'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group', 'description': "GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F.", 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype) included participants who were enrolled, received 20vPnC in the 20vPnC/saline group or received both vaccinations in the 13vPnC/PPSV23 group, had ≥1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27-49 days after Vaccination 1 or 2 respectively, had no other major PDs.Number Analyzed=participants evaluable with OPA titers available at both timepoints at specified serotypes'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '69.0', 'upperLimit': '75.9'}, {'value': '74.2', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '77.4'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '680', 'groupId': 'OG000'}, {'value': '679', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '61.4'}, {'value': '59.4', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '63.1'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}, {'value': '661', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '76.8', 'upperLimit': '83.1'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '76.3', 'upperLimit': '82.6'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '51.1', 'upperLimit': '58.7'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '63.3'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '672', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '75.6', 'upperLimit': '81.9'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '80.7'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '74.7'}, {'value': '70.6', 'groupId': 'OG001', 'lowerLimit': '66.9', 'upperLimit': '74.2'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}, {'value': '636', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '59.6'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '58.0', 'upperLimit': '65.7'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '646', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '64.3'}, {'value': '62.8', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '66.5'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '55.6', 'upperLimit': '63.3'}, {'value': '53.4', 'groupId': 'OG001', 'lowerLimit': '49.5', 'upperLimit': '57.3'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '69.8', 'upperLimit': '76.6'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '82.1'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '76.3', 'upperLimit': '82.5'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '85.2'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '674', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '66.1'}, {'value': '69.9', 'groupId': 'OG001', 'lowerLimit': '66.3', 'upperLimit': '73.4'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '66.2', 'upperLimit': '73.2'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '75.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or 13vPnC for the 13 matching serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major PDs. Number Analyzed=participants evaluable with OPA titers available at both timepoints at specified serotype.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '689', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.5', 'groupId': 'OG000', 'lowerLimit': '77.3', 'upperLimit': '83.4'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '83.5', 'upperLimit': '88.8'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}, {'value': '633', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.2', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '73.7'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '52.1', 'upperLimit': '60.0'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}, {'value': '552', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '73.2'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '48.8', 'upperLimit': '57.3'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '602', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '89.5'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '83.8'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '637', 'groupId': 'OG000'}, {'value': '632', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000', 'lowerLimit': '70.0', 'upperLimit': '77.0'}, {'value': '59.7', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '63.5'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '78.8'}, {'value': '70.8', 'groupId': 'OG001', 'lowerLimit': '67.0', 'upperLimit': '74.4'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '623', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '64.9'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or PPSV23 for the 7 additional serotypes, including 8, 10A, 11A, 12F, 15B, 22F, and 33F were summarized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype): participants who were enrolled, received 20vPnC in the 20vPnC/saline group or received both vaccinations in the 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or 2 respectively, had no other major PDs. Number Analyzed=participants evaluable with OPA titers available at both timepoints at specified rows'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '688', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '86.9'}, {'value': '85.6', 'groupId': 'OG001', 'lowerLimit': '82.8', 'upperLimit': '88.1'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '85.1'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '85.2'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '93.7'}, {'value': '92.4', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '94.2'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '71.1'}, {'value': '70.7', 'groupId': 'OG001', 'lowerLimit': '67.2', 'upperLimit': '74.1'}]}]}, {'title': 'Serotype 6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '91.9'}, {'value': '88.8', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '91.1'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '668', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '89.1', 'upperLimit': '93.5'}, {'value': '90.2', 'groupId': 'OG001', 'lowerLimit': '87.7', 'upperLimit': '92.4'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '99.0'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '98.9'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '681', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.2', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '89.6'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '85.6', 'upperLimit': '90.6'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000', 'lowerLimit': '89.8', 'upperLimit': '94.0'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '85.7', 'upperLimit': '90.7'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '95.1'}, {'value': '94.8', 'groupId': 'OG001', 'lowerLimit': '92.8', 'upperLimit': '96.3'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '96.5'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '98.0'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '681', 'groupId': 'OG000'}, {'value': '683', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '79.5'}, {'value': '82.3', 'groupId': 'OG001', 'lowerLimit': '79.2', 'upperLimit': '85.1'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '82.7'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '79.3', 'upperLimit': '85.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC or 13vPnC for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 13-matched immunogenicity population (for any serotype) included participants who were enrolled, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major PDs. Number analyzed=participants evaluable for this OM at specified rows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '689', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '96.7'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '95.1', 'upperLimit': '97.9'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '93.2'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '78.9', 'upperLimit': '84.9'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '98.1'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '90.0', 'upperLimit': '94.3'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '98.1'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '89.3', 'upperLimit': '93.7'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '92.4'}, {'value': '80.3', 'groupId': 'OG001', 'lowerLimit': '77.1', 'upperLimit': '83.3'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '97.8'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '95.1'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}, {'value': '653', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '98.5'}, {'value': '96.5', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '97.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC in the 20vPnC/saline groups or PPSV23 in the 13vPnC/PPSV23 group for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants Analyzed=Evaluable 7-additional immunogenicity population (for any serotype): participants who were enrolled, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major PDs. Number analyzed=participants evaluable at specified rows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Redness-Any', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.8'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '21.2'}]}]}, {'title': 'Redness-Mild', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.8'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.9'}]}]}, {'title': 'Redness-Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.9'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '11.3'}]}]}, {'title': 'Redness-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.9'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '8.0'}]}]}, {'title': 'Swelling-Any', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.5'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '32.9'}]}]}, {'title': 'Swelling-Mild', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.5'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '10.8'}]}]}, {'title': 'Swelling-Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.9'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '17.2'}]}]}, {'title': 'Swelling-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.9'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '9.9'}]}]}, {'title': 'Pain at the injection site-Any', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '8.3'}, {'value': '73.1', 'groupId': 'OG001', 'lowerLimit': '68.6', 'upperLimit': '77.3'}]}]}, {'title': 'Pain at the injection site-Mild', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '8.3'}, {'value': '46.0', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '50.9'}]}]}, {'title': 'Pain at the injection site-Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '28.9'}]}]}, {'title': 'Pain at the injection site-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group', 'description': 'Reactions within 10 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nRedness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm), and severe (\\>10.0 cm).\n\nPain at the injection site was grades as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity).\n\nThis endpoint was requested by local Japan regulator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants enrolled at Japan sites who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed" is participants enrolled at Japan sites with any e-diary data reported after PPSV23 or saline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'OG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'classes': [{'title': 'Fever ≥38.0°C', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '3.5'}]}]}, {'title': 'Fever ≥38.0°C to 38.4°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.1'}]}]}, {'title': 'Fever >38.4°C to 38.9°C', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.3'}]}]}, {'title': 'Fever >38.9°C to 40.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}, {'title': 'Fever >40.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}, {'title': 'Fatigue-Any', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '12.8'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '26.9'}]}]}, {'title': 'Fatigue-Mild', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '10.9'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '19.6'}]}]}, {'title': 'Fatigue-Moderate', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.2'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '8.8'}]}]}, {'title': 'Fatigue-Severe', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.1'}]}]}, {'title': 'Headache-Any', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '7.5'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '12.7'}]}]}, {'title': 'Headache-Mild', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '6.9'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '11.0'}]}]}, {'title': 'Headache-Moderate', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.8'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '2.8'}]}]}, {'title': 'Headache-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.3'}]}]}, {'title': 'Muscle pain-Any', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '6.6'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '29.9'}]}]}, {'title': 'Muscle pain-Mild', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '6.0'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '20.4'}]}]}, {'title': 'Muscle pain-Moderate', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.8'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '11.0'}]}]}, {'title': 'Muscle pain-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '2.5'}]}]}, {'title': 'Joint pain-Any', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '3.5'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '8.8'}]}]}, {'title': 'Joint pain-Mild', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.2'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '6.8'}]}]}, {'title': 'Joint pain-Moderate', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.1'}]}]}, {'title': 'Joint pain-Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group', 'description': 'Events within 7 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nFever was categorized as ≥38.0 °C, ≥38.0°C to 38.4°C, \\>38.4°C to 38.9°C, \\>38.9°C to 40.0°C, and \\>40.0°C.\n\nFatigue, headache, muscle pain, and joint pain were grades as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity).\n\nThis endpoint was requested by local Japan regulator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants enrolled at Japan sites who received at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline) and had safety follow-up after any vaccination. Here, "Number of Participants Analyzed" is participants enrolled at Japan sites with any e-diary data reported after PPSV23 or saline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 milliliter (mL) 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'FG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Participants Vaccinated with Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '710'}]}, {'type': 'Vaccinated With Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '695'}, {'groupId': 'FG001', 'numSubjects': '699'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '692'}, {'groupId': 'FG001', 'numSubjects': '699'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'No longer meets eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants 60 years of age and above were recruited into this study to received either Pneumococcal Conjugate Vaccine (20vPnC)/saline or 13-valent pneumococcal conjugate vaccine (13vPnC)/23-valent pneumococcal polysaccharide vaccine (PPSV23).', 'preAssignmentDetails': 'A total of 1425 participants were randomized to receive either 20vPnC/saline (713 participants) or 13vPnC/PPSV23 (712 participants); 2 participants in the 20vPnC/saline group and 2 participants in the 13vPnC/PPSV23 group were not vaccinated, therefore, a total of 1421 participants were vaccinated and included in the summary..'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'BG000'}, {'value': '710', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '20vPnC/Saline', 'description': 'Participants aged 60 years and above received a single dose of 0.5 mL 20vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL saline intramuscularly at Vaccination 2 (28 to 42 Days after vaccination1).'}, {'id': 'BG001', 'title': '13vPnC/PPSV23', 'description': 'Participants 60 years of age and above received a single dose of 0.5 mL 13vPnC intramuscularly at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscularly PPSV23 at Vaccination 2 (28 to 42 Days after Vaccination 1).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '4.46', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '4.83', 'groupId': 'BG001'}, {'value': '66.1', 'spread': '4.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '60 to 64 years', 'categories': [{'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}]}]}, {'title': '65 to 74 years', 'categories': [{'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '353', 'groupId': 'BG001'}, {'value': '719', 'groupId': 'BG002'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '630', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '396', 'groupId': 'BG000'}, {'value': '395', 'groupId': 'BG001'}, {'value': '791', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '711', 'groupId': 'BG000'}, {'value': '710', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '711', 'groupId': 'BG000'}, {'value': '710', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who receive at least 1 dose of the study intervention (20vPnC, 13vPnC, PPSV23 or saline).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-13', 'size': 10684224, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-10T09:44', 'hasProtocol': True}, {'date': '2022-09-27', 'size': 3539658, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-10T09:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2021-05-03', 'resultsFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-05', 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': 'Within 10 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'Reactions were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nRedness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm), and severe (\\>10.0 cm).\n\nPain at the injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity).'}, {'measure': 'Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': 'Within 7 days after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'Events were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nFever was categorized as ≥38.0 degree Celsius (°C), ≥38.0°C to 38.4°C, \\>38.4°C to 38.9°C, \\>38.9°C to 40.0°C, and \\>40.0°C.\n\nFatigue, headache, muscle pain, and joint pain were graded as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity).'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': 'Within 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': 'Within 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'description': 'An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event.'}, {'measure': 'Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13-matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': '1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'OPA titers were determined for the 13 matching pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. GMTs and 2-sided CIs were calculated by exponentiating the Least Square (LS) means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.'}, {'measure': 'Pneumococcal OPA GMTs for 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)', 'timeFrame': '1 month after 20vPnC in the 20vPnC/Saline group or 1 month after PPSV23 in the 13vPnC/PPSV23 group.', 'description': 'OPA titers were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model with vaccine group, sex, smoking status, age at vaccination in years (continuous), baseline log-transformed OPA titers, and country.'}], 'secondaryOutcomes': [{'measure': 'OPA Geometric Mean Fold Rise (GMFRs) For 13-matched Serotypes From Before To 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': 'Before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group.', 'description': "GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F."}, {'measure': 'OPA GMFRs for 7 Additional Serotypes From Before to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23)', 'timeFrame': 'From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group', 'description': "GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution), for serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F."}, {'measure': 'Percentage of Participants With ≥4 Fold Rise for 13-matched Serotypes of OPA Titers From Before to 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': 'From before Vaccination 1 to 1 month after 20vPnC in the 20vPnC/Saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or 13vPnC for the 13 matching serotypes, including 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were summarized.'}, {'measure': 'Percentage of Participants With ≥4 Fold Rise in 7 Additional Serotypes of OPA Titers From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23)', 'timeFrame': 'From before Vaccination 1 (20vPnC) to 1 month after Vaccination 1 (20vPnC) in the 20vPnC/Saline group or from before Vaccination 1 (13vPnC) to 1 month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with a ≥4-fold rise in OPA titers and associated 95% CI before vaccination to 1 month after vaccination with 20vPnC or PPSV23 for the 7 additional serotypes, including 8, 10A, 11A, 12F, 15B, 22F, and 33F were summarized.'}, {'measure': 'Percentage of Participants With 13-matched Serotypes of OPA Titers ≥The Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 (20vPnC or 13vPnC)', 'timeFrame': '1 month after 20vPnC in the 20vPnC/saline group or 13vPnC in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC or 13vPnC for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.'}, {'measure': 'Percentage of Participants With Pneumococcal OPA Titers ≥LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23)', 'timeFrame': '1 month after Vaccination 1 (20vPnC) in the 20vPnC/saline group or a month after Vaccination 2 (PPSV23) in the 13vPnC/PPSV23 group', 'description': 'The percentage of participants with OPA titers ≥LLOQ and associated 95% CIs were calculated for the time point 1 month after vaccination with 20vPnC in the 20vPnC/saline groups or PPSV23 in the 13vPnC/PPSV23 group for serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F.'}, {'measure': 'Percentage of Participants With Prompted Local Reactions Within 10 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites', 'timeFrame': 'Within 10 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group', 'description': 'Reactions within 10 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including redness, swelling, and pain at the injection site. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nRedness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm), and severe (\\>10.0 cm).\n\nPain at the injection site was grades as mild (does not interfere with activity), moderate (interferes with activity), and severe (prevents daily activity).\n\nThis endpoint was requested by local Japan regulator.'}, {'measure': 'Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination 2 (PPSV23 or Saline) in Participants Enrolled at Japan Sites', 'timeFrame': 'Within 7 days after saline in 20vPnC/Saline group or PPSV23 in 13vPnC/PPSV23 group', 'description': 'Events within 7 days after Vaccination 2 (PPSV23 or saline) in participants enrolled at Japan sites were collected in the e-diary including fever, headache, fatigue, muscle pain, and joint pain. Exact 2-sided CI was calculated based on the Clopper and Pearson method.\n\nFever was categorized as ≥38.0 °C, ≥38.0°C to 38.4°C, \\>38.4°C to 38.9°C, \\>38.9°C to 40.0°C, and \\>40.0°C.\n\nFatigue, headache, muscle pain, and joint pain were grades as mild (does not interfere with activity), moderate (some interference with activity), and severe (prevents daily activity).\n\nThis endpoint was requested by local Japan regulator.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'referencesModule': {'references': [{'pmid': '38267330', 'type': 'DERIVED', 'citation': 'Haranaka M, Young Song J, Huang KC, de Solom R, Yamaji M, McElwee K, Kline M, Aizawa M, Peng Y, Scully I, Kogawara O, Gruber WC, Scott DA, Watson W. A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults >/= 60 years of age in Japan, South Korea, and Taiwan. Vaccine. 2024 Feb 15;42(5):1071-1077. doi: 10.1016/j.vaccine.2024.01.004. Epub 2024 Jan 23.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7471009', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Male or female participants 60 years of age and older at the time of consent.\n* Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention. (For adults 60 through 64 years of age to be enrolled at Japan sites: Participants must have a preexisting chronic stable disease with an elevated risk for pneumococcal disease.)\n\nExclusion criteria:\n\n* History of microbiologically proven invasive disease caused by S pneumoniae.\n* Serious chronic disorder, including metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.\n* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation."}, 'identificationModule': {'nctId': 'NCT04875533', 'briefTitle': '20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 60 YEARS OF AGE AND OLDER IN JAPAN, KOREA, AND TAIWAN', 'orgStudyIdInfo': {'id': 'B7471009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20vPnC/Saline', 'description': '20vPnC and saline', 'interventionNames': ['Biological: 20vPnC', 'Other: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '13vPnC/PPSV23', 'description': '13vPnC and PPSV23', 'interventionNames': ['Biological: 13vPnC', 'Biological: PPSV23']}], 'interventions': [{'name': '20vPnC', 'type': 'BIOLOGICAL', 'description': '20vPnC', 'armGroupLabels': ['20vPnC/Saline']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Saline', 'armGroupLabels': ['20vPnC/Saline']}, {'name': '13vPnC', 'type': 'BIOLOGICAL', 'description': 'Pneumococcal conjugate vaccine', 'armGroupLabels': ['13vPnC/PPSV23']}, {'name': 'PPSV23', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumovax 23'], 'description': 'Pneumococcal polysaccharide vaccine', 'armGroupLabels': ['13vPnC/PPSV23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '819-1104', 'city': 'Itoshima', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Seishinkai Inoue Hospital', 'geoPoint': {'lat': 33.54225, 'lon': 130.18421}}, {'zip': '231-0861', 'city': 'Naka-ku, Yokohama-Shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': "Women's Clinic LUNA NEXT STAGE", 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '532-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OPHAC Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '565-0853', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OCROM Clinic'}, {'zip': '103-0025', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nihonbashi Sakura Clinic'}, {'zip': '104-0031', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Fukuwa Clinic'}, {'zip': '1920071', 'city': 'Hachioji-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'P-one Clinic, Keikokai Medical Corporation'}, {'zip': '1500001', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Hillside Clinic Jingumae'}, {'zip': '160-0008', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai ToCROM Clinic'}, {'zip': '812-0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'SOUSEIKAI PS Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '15355', 'city': 'Ansan-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.32361, 'lon': 126.82194}}, {'zip': '16247', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic University of Korea, St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '08308', 'city': 'Seoul', 'state': 'Seoul-teukbyeolsi [seoul]', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05355', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07985', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '220', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '23561', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Taipei Medical University Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], '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'}}}}