Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2026-03-31 @ 9:04 PM
Study NCT ID:
NCT02124161
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1--800--718--1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC+QIV/Placebo: After Vaccination 1', 'description': 'All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.', 'otherNumAtRisk': 439, 'otherNumAffected': 62, 'seriousNumAtRisk': 439, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo+QIV/13vPnC: After Vaccination 1', 'description': 'All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.', 'otherNumAtRisk': 437, 'otherNumAffected': 52, 'seriousNumAtRisk': 437, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '13vPnC+QIV/Placebo: After Vaccination 2', 'description': 'All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.', 'otherNumAtRisk': 431, 'otherNumAffected': 42, 'seriousNumAtRisk': 431, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo+QIV/13vPnC: After Vaccination 2', 'description': 'All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.', 'otherNumAtRisk': 432, 'otherNumAffected': 51, 'seriousNumAtRisk': 432, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': '13vPnC+QIV/Placebo: After 13vPnC Vaccination', 'description': 'All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.', 'otherNumAtRisk': 439, 'otherNumAffected': 62, 'seriousNumAtRisk': 439, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Placebo+QIV/13vPnC: After 13vPnC Vaccination', 'description': 'All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.', 'otherNumAtRisk': 432, 'otherNumAffected': 51, 'seriousNumAtRisk': 432, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': '13vPnC+QIV/Placebo: at 6-Month Follow-up', 'description': 'All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.', 'otherNumAtRisk': 439, 'otherNumAffected': 6, 'seriousNumAtRisk': 439, 'seriousNumAffected': 5}, {'id': 'EG007', 'title': 'Placebo+QIV/13vPnC: at 6-Month Follow-up', 'description': 'All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.', 'otherNumAtRisk': 437, 'otherNumAffected': 6, 'seriousNumAtRisk': 437, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vaccination site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vaccination site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 4}, {'groupId': 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'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bone loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 432, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 437, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Serotype 1 (n= 419, 417)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '87.0'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '71.1', 'upperLimit': '96.1'}]}]}, {'title': 'Serotype 3 (n= 422, 418)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '36.2', 'upperLimit': '46'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '43.6', 'upperLimit': '55.3'}]}]}, {'title': 'Serotype 4 (n= 412, 417)', 'categories': [{'measurements': [{'value': '587', 'groupId': 'OG000', 'lowerLimit': '489.9', 'upperLimit': '702.5'}, {'value': '824', 'groupId': 'OG001', 'lowerLimit': '692.2', 'upperLimit': '980'}]}]}, {'title': 'Serotype 5 (n= 423, 414)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '111.7'}, {'value': '101', 'groupId': 'OG001', 'lowerLimit': '86.6', 'upperLimit': '117.2'}]}]}, {'title': 'Serotype 6A (n= 420, 415)', 'categories': [{'measurements': [{'value': '953', 'groupId': 'OG000', 'lowerLimit': '805.7', 'upperLimit': '1126.3'}, {'value': '1413', 'groupId': 'OG001', 'lowerLimit': '1203.3', 'upperLimit': '1659.4'}]}]}, {'title': 'Serotype 6B (n= 414, 405)', 'categories': [{'measurements': [{'value': '867', 'groupId': 'OG000', 'lowerLimit': '722.3', 'upperLimit': '1039.6'}, {'value': '1041', 'groupId': 'OG001', 'lowerLimit': '860.5', 'upperLimit': '1260'}]}]}, {'title': 'Serotype 7F (n= 424, 419)', 'categories': [{'measurements': [{'value': '651', 'groupId': 'OG000', 'lowerLimit': '582.4', 'upperLimit': '728'}, {'value': '670', 'groupId': 'OG001', 'lowerLimit': '599.7', 'upperLimit': '748.5'}]}]}, {'title': 'Serotype 9V (n= 419, 415)', 'categories': [{'measurements': [{'value': '699', 'groupId': 'OG000', 'lowerLimit': '613.7', 'upperLimit': '797.2'}, {'value': '838', 'groupId': 'OG001', 'lowerLimit': '734.2', 'upperLimit': '957.5'}]}]}, {'title': 'Serotype 14 (n= 421, 416)', 'categories': [{'measurements': [{'value': '574', 'groupId': 'OG000', 'lowerLimit': '496.8', 'upperLimit': '663'}, {'value': '760', 'groupId': 'OG001', 'lowerLimit': '665.6', 'upperLimit': '868'}]}]}, {'title': 'Serotype 18C (n= 420, 414)', 'categories': [{'measurements': [{'value': '713', 'groupId': 'OG000', 'lowerLimit': '598.9', 'upperLimit': '849.9'}, {'value': '865', 'groupId': 'OG001', 'lowerLimit': '726.4', 'upperLimit': '1030.5'}]}]}, {'title': 'Serotype 19A (n= 425, 419)', 'categories': [{'measurements': [{'value': '337', 'groupId': 'OG000', 'lowerLimit': '294.9', 'upperLimit': '384.6'}, {'value': '390', 'groupId': 'OG001', 'lowerLimit': '344.4', 'upperLimit': '441.1'}]}]}, {'title': 'Serotype 19F (n= 423, 416)', 'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000', 'lowerLimit': '274.8', 'upperLimit': '382.5'}, {'value': '360', 'groupId': 'OG001', 'lowerLimit': '302.7', 'upperLimit': '427.9'}]}]}, {'title': 'Serotype 23F (n= 421, 417)', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000', 'lowerLimit': '223.9', 'upperLimit': '344.7'}, {'value': '364', 'groupId': 'OG001', 'lowerLimit': '294.3', 'upperLimit': '451.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.12', 'groupDescription': 'Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.98', 'groupDescription': 'Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.91', 'groupDescription': 'Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.18', 'groupDescription': 'Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.85', 'groupDescription': 'Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.08', 'groupDescription': 'Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.14', 'groupDescription': 'Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.0', 'groupDescription': 'Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.92', 'groupDescription': 'Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.06', 'groupDescription': 'Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.04', 'groupDescription': 'Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.14', 'groupDescription': 'Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.03', 'groupDescription': 'Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC', 'description': 'Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Strain: A/H1N1', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '104.0', 'upperLimit': '126.8'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '101.6', 'upperLimit': '124.7'}]}]}, {'title': 'Strain: A/H3N2', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000', 'lowerLimit': '206.1', 'upperLimit': '248.5'}, {'value': '196', 'groupId': 'OG001', 'lowerLimit': '178.0', 'upperLimit': '216.1'}]}]}, {'title': 'Strain: B/Brisbane', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '31.0'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '28.7'}]}]}, {'title': 'Strain: B/Massachusetts', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '50.3'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '48.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.18', 'groupDescription': 'Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.32', 'groupDescription': 'Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.24', 'groupDescription': 'Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.21', 'groupDescription': 'Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 1', 'description': 'HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 to 42 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 to 42 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of vaccination. Here, "number of participants analyzed" signifies participants who were evaluable at this timepoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '7.4', 'groupDescription': 'AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.7', 'groupDescription': 'SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of vaccination. Here, "number of participants analyzed" signifies participants who were evaluable at this timepoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 168 to 196 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Serotype 1 (n= 419, 417)', 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '81.3'}, {'value': '80.1', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '83.8'}]}]}, {'title': 'Serotype 3 (n= 422, 418)', 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '83.1'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '79.8', 'upperLimit': '87.1'}]}]}, {'title': 'Serotype 4 (n= 412, 417)', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '91.5'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '89.1', 'upperLimit': '94.5'}]}]}, {'title': 'Serotype 5 (n= 423, 414)', 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000', 'lowerLimit': '70.0', 'upperLimit': '78.6'}, {'value': '72.7', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '76.9'}]}]}, {'title': 'Serotype 6A (n= 420, 415)', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '93.1'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '96.3'}]}]}, {'title': 'Serotype 6B (n= 414, 405)', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '88.3'}, {'value': '86.4', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '89.6'}]}]}, {'title': 'Serotype 7F (n= 424, 419)', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '78.3', 'upperLimit': '85.8'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '79.6', 'upperLimit': '87.0'}]}]}, {'title': 'Serotype 9V (n= 419, 415)', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '69.7'}, {'value': '71.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '75.6'}]}]}, {'title': 'Serotype 14 (n= 421, 416)', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '93.9'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '97.0'}]}]}, {'title': 'Serotype 18C (n= 420, 414)', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.4', 'upperLimit': '91.7'}, {'value': '91.3', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '93.8'}]}]}, {'title': 'Serotype 19A (n= 425, 419)', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '97.3'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '95.4', 'upperLimit': '98.7'}]}]}, {'title': 'Serotype 19F (n= 423, 416)', 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '83.6'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '75.4', 'upperLimit': '83.3'}]}]}, {'title': 'Serotype 23F (n= 421, 417)', 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '84.0'}, {'value': '84.2', 'groupId': 'OG001', 'lowerLimit': '80.3', 'upperLimit': '87.5'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '2.8', 'groupDescription': 'Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '0.9', 'groupDescription': 'Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-7.6', 'ciUpperLimit': '0.6', 'groupDescription': 'Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '7.8', 'groupDescription': 'Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '-0.1', 'groupDescription': 'Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.574', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '3.4', 'groupDescription': 'Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '3.9', 'groupDescription': 'Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '0.2', 'groupDescription': 'Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '-0.3', 'groupDescription': 'Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '1.6', 'groupDescription': 'Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '0.7', 'groupDescription': 'Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.926', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '5.8', 'groupDescription': 'Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC', 'description': 'Percentage of participants achieving predefined OPA antibody titer \\>= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results to the specified serotype.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Serotype 1 (n= 417)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.14'}]}]}, {'title': 'Serotype 3 (n= 419)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '3.85'}]}]}, {'title': 'Serotype 4 (n= 399)', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.33', 'upperLimit': '11.18'}]}]}, {'title': 'Serotype 5 (n= 422)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.70', 'upperLimit': '3.43'}]}]}, {'title': 'Serotype 6A (n= 408)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '11.30', 'upperLimit': '16.62'}]}]}, {'title': 'Serotype 6B (n= 391)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '7.29', 'upperLimit': '10.87'}]}]}, {'title': 'Serotype 7F (n= 417)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '2.98'}]}]}, {'title': 'Serotype 9V (n= 405)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '2.38'}]}]}, {'title': 'Serotype 14 (n= 411)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.30'}]}]}, {'title': 'Serotype 18C (n= 417)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.38', 'upperLimit': '4.74'}]}]}, {'title': 'Serotype 19A (n= 424)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.28'}]}]}, {'title': 'Serotype 19F (n= 419)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.60', 'upperLimit': '4.87'}]}]}, {'title': 'Serotype 23F (n= 418)', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.07', 'upperLimit': '10.61'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before Vaccination 1, 1 month after Vaccination 1', 'description': 'GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Serotype 1 (n =413)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.19', 'upperLimit': '4.16'}]}]}, {'title': 'Serotype 3 (n= 414)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.47', 'upperLimit': '4.42'}]}]}, {'title': 'Serotype 4 (n= 391)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '12.94'}]}]}, {'title': 'Serotype 5 (n= 411)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '3.72'}]}]}, {'title': 'Serotype 6A (n= 399)', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '14.73', 'upperLimit': '21.86'}]}]}, {'title': 'Serotype 6B (n= 382)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '7.69', 'upperLimit': '11.67'}]}]}, {'title': 'Serotype 7F (n= 407)', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.41', 'upperLimit': '3.03'}]}]}, {'title': 'Serotype 9V (n= 399)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '2.12', 'upperLimit': '2.71'}]}]}, {'title': 'Serotype 14 (n= 406)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.60'}]}]}, {'title': 'Serotype 18C (n= 408)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.21', 'upperLimit': '7.51'}]}]}, {'title': 'Serotype 19A (n= 416)', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '4.02', 'upperLimit': '5.35'}]}]}, {'title': 'Serotype 19F (n= 410)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.12', 'upperLimit': '5.69'}]}]}, {'title': 'Serotype 23F (n= 412)', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '10.42', 'upperLimit': '15.88'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before Vaccination 2, 1 month after Vaccination 2', 'description': 'GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, "number of participants analyzed" signifies total participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Strain: A/H1N1', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '33.8'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '28.5'}]}]}, {'title': 'Strain: A/H3N2', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '32.4'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '36.3'}]}]}, {'title': 'Strain: B/Brisbane', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '25.5'}, {'value': '22.3', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '26.6'}]}]}, {'title': 'Strain: B/Massachusetts', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '27.5'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '29.0'}]}]}], 'analyses': [{'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '11.0', 'groupDescription': 'Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'pValue': '0.232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '2.4', 'groupDescription': 'Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'pValue': '0.734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '4.5', 'groupDescription': 'Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}, {'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '4.3', 'groupDescription': 'Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.', 'statisticalMethod': 'Chan and Zhang method', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).'}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately before Vaccination 1, 1 month after Vaccination 1', 'description': 'Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than \\<1:10 and after Vaccination 1 (post-vaccination 1) HAI titer \\>=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer \\>=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'OG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'classes': [{'title': 'Strain: A/H1N1', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '2.17', 'upperLimit': '2.64'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '2.41'}]}]}, {'title': 'Strain: A/H3N2', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '2.51'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.15', 'upperLimit': '2.59'}]}]}, {'title': 'Strain: B/Brisbane', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '2.32'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.98', 'upperLimit': '2.34'}]}]}, {'title': 'Strain: B/Massachusetts', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.34'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.98', 'upperLimit': '2.30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately before Vaccination 1, 1 month after Vaccination 1', 'description': 'Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, "number of participants analyzed" signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'FG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '441'}, {'groupId': 'FG001', 'numSubjects': '441'}]}, {'type': 'Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '437'}]}, {'type': 'Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '431'}, {'groupId': 'FG001', 'numSubjects': '432'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '425'}, {'groupId': 'FG001', 'numSubjects': '426'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Other unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Does not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'No longer meets eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '882 participants who were greater than or equal to (\\>=) 50 years of age and previously vaccinated with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) were randomized in this study but 6 participants (2 participants in 13vPnC+QIV/Placebo arm and 4 participants in Placebo+QIV/13vPnC arm) were randomized but not vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'BG000'}, {'value': '437', 'groupId': 'BG001'}, {'value': '876', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC+QIV/Placebo', 'description': 'Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'BG001', 'title': 'Placebo+QIV/13vPnC', 'description': 'Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '9', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '8.85', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '8.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least 1 dose of vaccination.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 882}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-23', 'studyFirstSubmitDate': '2014-04-24', 'resultsFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-23', 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes', 'timeFrame': '1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC', 'description': 'Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.'}, {'measure': 'Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)', 'timeFrame': '1 month after Vaccination 1', 'description': 'HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.'}, {'measure': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1', 'timeFrame': 'Within 28 to 42 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).'}, {'measure': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2', 'timeFrame': 'Within 28 to 42 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).'}, {'measure': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination', 'timeFrame': 'Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).'}, {'measure': 'Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up', 'timeFrame': 'Within 168 to 196 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)', 'timeFrame': '1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC', 'description': 'Percentage of participants achieving predefined OPA antibody titer \\>= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results to the specified serotype.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1', 'timeFrame': 'Immediately before Vaccination 1, 1 month after Vaccination 1', 'description': 'GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2', 'timeFrame': 'Immediately before Vaccination 2, 1 month after Vaccination 2', 'description': 'GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, "number of participants analyzed" signifies total participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.'}, {'measure': 'Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers', 'timeFrame': 'Immediately before Vaccination 1, 1 month after Vaccination 1', 'description': 'Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than \\<1:10 and after Vaccination 1 (post-vaccination 1) HAI titer \\>=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer \\>=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1', 'timeFrame': 'Immediately before Vaccination 1, 1 month after Vaccination 1', 'description': 'Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, "number of participants analyzed" signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumococcal polysaccharide vaccine', '13-valent pneumococcal conjugate vaccine', 'invasive pneumococcal disease', 'flu vaccine'], 'conditions': ['PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851138&StudyName=Concomitant%20administration%20of%2013-valent%20Pneumococcal%20Conjugate%20Vaccine%20%2813vPnC%29%20with%20influenza%20vaccine%20in%2023-valent%20Pneumococcal%20Polysaccharid', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.\n2. Male or female adults 50 years of age or older.\n3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.\n4. Negative urine pregnancy test for all female subjects who are of child bearing potential.\n\nExclusion Criteria:\n\n1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.\n2. History of severe adverse reactions associated with any vaccine or vaccine-related component.\n3. Allergic to egg proteins (egg or egg products) and chicken proteins.\n4. History of Guillain-Barré syndrome.\n5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.\n6. Documented S pneumoniae infection within the past 5 years before investigational product administration.'}, 'identificationModule': {'nctId': 'NCT02124161', 'briefTitle': 'Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.', 'orgStudyIdInfo': {'id': 'B1851138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '13vPnC+SIIV/Placebo', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine', 'Biological: Seasonal Inactivated Influenza Vaccine', 'Other: Placebo']}, {'type': 'OTHER', 'label': 'Placebo+SIIV/13vPnC', 'interventionNames': ['Other: Placebo', 'Biological: Seasonal Inactivated Influenza Vaccine', 'Biological: 13-valent pneumococcal conjugate vaccine']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['13vPnC'], 'description': 'One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.', 'armGroupLabels': ['13vPnC+SIIV/Placebo']}, {'name': 'Seasonal Inactivated Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['SIIV'], 'description': 'One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.', 'armGroupLabels': ['13vPnC+SIIV/Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.', 'armGroupLabels': ['13vPnC+SIIV/Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.', 'armGroupLabels': ['Placebo+SIIV/13vPnC']}, {'name': 'Seasonal Inactivated Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['SIIV'], 'description': 'One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.', 'armGroupLabels': ['Placebo+SIIV/13vPnC']}, {'name': '13-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['13vPnC'], 'description': 'One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.', 'armGroupLabels': ['Placebo+SIIV/13vPnC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35802', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Optimal Research (Formerly Accelovance)', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Vaccine Study Center', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanante South. 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'33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '46545', 'city': 'Mishawaka', 'state': 'Indiana', 'country': 'United States', 'facility': 'Optimal Research, LLC', 'geoPoint': {'lat': 41.66199, 'lon': -86.15862}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc/Ridge Family Practice', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Johnson County Clin-Trials, Inc.', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '70002', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '68005', 'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada, LLC', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': 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States', 'facility': 'PMG Research of Hickory, LLC', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Trials of America, Inc.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Winston-Salem', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research, Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45005', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Prestige Clinical Research', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '15106', 'city': 'Carnegie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians, Inc.', 'geoPoint': {'lat': 40.40868, 'lon': -80.08339}}, {'zip': '19335', 'city': 'Downingtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Brandywine Clinical Research', 'geoPoint': {'lat': 40.0065, 'lon': -75.70327}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Omega Medical Research', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'PMG Research of Charleston', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Internal Medicine and Pediatric Associates of Bristol, PC', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Volunteer Research Group', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76735', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diagnostics Research Group', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84123', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Jordan River Family Medicine', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}