Viewing Study NCT04120194

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Ignite Creation Date: 2025-12-25 @ 1:45 AM
Ignite Modification Date: 2026-03-03 @ 12:02 AM
Study NCT ID: NCT04120194
Status: COMPLETED
Last Update Posted: 2023-05-06
First Post: 2019-10-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}}}}, '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@novavax.com', 'phone': '1-844-Novavax (668-2829)', 'title': 'Novavax Customer Service Center', 'organization': 'Novavax Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Serious Adverse Events', 'eventGroups': [{'id': 'EG000', 'title': 'NanoFlu', 'description': 'NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nNanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.', 'otherNumAtRisk': 1333, 'deathsNumAtRisk': 1333, 'otherNumAffected': 0, 'seriousNumAtRisk': 1333, 'deathsNumAffected': 8, 'seriousNumAffected': 136}, {'id': 'EG001', 'title': 'Fluzone Quadrivalent', 'description': 'Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nFluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.', 'otherNumAtRisk': 1319, 'deathsNumAtRisk': 1319, 'otherNumAffected': 0, 'seriousNumAtRisk': 1319, 'deathsNumAffected': 8, 'seriousNumAffected': 125}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1319, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, 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'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '68.0', 'upperLimit': '73.5'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '67.2', 'upperLimit': '72.5'}]}]}, {'title': 'Day 28 - B (Victoria Lineage)', 'categories': [{'measurements': [{'value': '110.7', 'groupId': 'OG000', 'lowerLimit': '106.1', 'upperLimit': '115.6'}, {'value': '106.3', 'groupId': 'OG001', 'lowerLimit': '102.3', 'upperLimit': '110.6'}]}]}, {'title': 'Day 0 - B (Yamagata Lineage)', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '72.3'}, {'value': '66.5', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '69.6'}]}]}, {'title': 'Day 28- B (Yamagata Lineage)', 'categories': [{'measurements': [{'value': '168.5', 'groupId': 'OG000', 'lowerLimit': '160.2', 'upperLimit': '177.2'}, {'value': '133.9', 'groupId': 'OG001', 'lowerLimit': '127.7', 'upperLimit': '140.5'}]}]}, {'title': 'Day 0 - A/California (H3N2)', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '42.4', 'upperLimit': '46.7'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '46.0'}]}]}, {'title': 'Day 28- A/California (H3N2)', 'categories': [{'measurements': [{'value': '115.0', 'groupId': 'OG000', 'lowerLimit': '108.0', 'upperLimit': '122.4'}, {'value': '80.6', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '85.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 - Day 28', 'description': 'Homologous influenza strains and 1 antigenically drifted strain expressed as GMT', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) Population including all subjects provided consent, were randomized and received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the 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'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '2.7'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '1.9'}]}]}, {'title': 'Day 28 - A/Cardiff (H3N2)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '1.8'}]}]}, {'title': 'Day 364- A/Brisbane (H1N1)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.5'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.4'}]}]}, {'title': 'Day 364 - A/Kansas (H3N2)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '3.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.7'}]}]}, {'title': 'Day 364 - B/ Maryland (Victoria Lineage)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.0'}]}]}, {'title': 'Day 364 - B/Phuket (Yamagata Linage)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.2'}]}]}, {'title': 'Day 364 - A/California (H3N2)', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '65.8', 'upperLimit': '96.2'}, {'value': '75.7', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '87.3'}]}]}, {'title': 'Day 364 - A/Cardiff (H3N2)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 - 364', 'description': 'Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR.', 'unitOfMeasure': 'Geometric Mean Fold Rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.'}, {'type': 'SECONDARY', 'title': 'Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NanoFlu', 'description': 'NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nNanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}, {'id': 'OG001', 'title': 'Fluzone Quadrivalent', 'description': 'Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nFluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}], 'classes': [{'title': 'Day 28- A/Brisbane/02/2018 (H1N1) pdm09', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '35.4'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '23.7'}]}]}, {'title': 'Day 28-A/Kansas/14/2017 (H3N2)', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '67.2', 'upperLimit': '72.3'}, {'value': '49.5', 'groupId': 'OG001', 'lowerLimit': '46.7', 'upperLimit': '52.2'}]}]}, {'title': 'Day 28- B/Maryland/15/2016 (Victoria lineage)', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '27.5'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '15.4'}]}]}, {'title': 'Day 28- B/Phuket/3073/2013 (Yamagata lineage)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000', 'lowerLimit': '32.8', 'upperLimit': '38.1'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '19.9'}]}]}, {'title': 'Day 28 - A/California (H3N2)', 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000', 'lowerLimit': '34.5', 'upperLimit': '39.8'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '22.8'}]}]}, {'title': 'Day 28 - A/Cardiff (H3N2)', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '35.4'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '20.8'}]}]}, {'title': 'Day 364 - A/California (H3N2)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '30.9'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '14.9'}]}]}, {'title': 'Day 364 - A/Cardiff (H3N2)', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '34.5'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '17.3'}]}]}, {'title': 'Day 364- A/Brisbane/02/2018 (H1N1) pdm09', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '30.9'}, {'value': '19.6', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '32.4'}]}]}, {'title': 'Day 364-A/Kansas/14/2017 (H3N2)', 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '66.6'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '42.2'}]}]}, {'title': 'Day 364- B/Maryland/15/2016 (Victoria lineage)', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '29.1'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '19.6'}]}]}, {'title': 'Day 364- B/Phuket/3073/2013 (Yamagata lineage)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '15.5'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '12.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 - Day 364', 'description': 'Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.'}, {'type': 'SECONDARY', 'title': 'Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}, {'value': '1286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NanoFlu', 'description': 'NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nNanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}, {'id': 'OG001', 'title': 'Fluzone Quadrivalent', 'description': 'Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nFluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}], 'classes': [{'title': 'A/Brisbane/02/2018 (H1N1) pdm09', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '71.6'}, {'value': '64.5', 'groupId': 'OG001', 'lowerLimit': '61.9', 'upperLimit': '67.2'}]}]}, {'title': 'A/Kansas/14/2017 (H3N2)', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '99.3'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '98.9'}]}]}, {'title': 'B/Maryland/15/2016 (Victoria lineage)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '99.6'}, {'value': '98.7', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.2'}]}]}, {'title': 'B/Phuket/3073/2013 (Yamagata lineage)', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '99.5'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '96.5', 'upperLimit': '98.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) Population including all subjects provided consent, were randomized and received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined by the sponsor prior to database lock and unblinding.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NanoFlu', 'description': 'NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nNanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}, {'id': 'FG001', 'title': 'Fluzone Quadrivalent', 'description': 'Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nFluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1332'}, {'groupId': 'FG001', 'numSubjects': '1322'}]}, {'type': 'Safety Population', 'comment': 'The Safety Population was analyzed as actually treated (ie, based on the actual dose received).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1333'}, {'groupId': 'FG001', 'numSubjects': '1319'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1312'}, {'groupId': 'FG001', 'numSubjects': '1302'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Voluntary withdrawal unrelated to adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1333', 'groupId': 'BG000'}, {'value': '1319', 'groupId': 'BG001'}, {'value': '2652', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NanoFlu', 'description': 'NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nNanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}, {'id': 'BG001', 'title': 'Fluzone Quadrivalent', 'description': 'Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.\n\nFluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '72.5', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '72.5', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '792', 'groupId': 'BG000'}, {'value': '845', 'groupId': 'BG001'}, {'value': '1637', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '541', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '1015', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1269', 'groupId': 'BG000'}, {'value': '1254', 'groupId': 'BG001'}, {'value': '2523', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1208', 'groupId': 'BG000'}, {'value': '1200', 'groupId': 'BG001'}, {'value': '2408', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received 2018-2019 Influenza Vaccine', 'classes': [{'categories': [{'measurements': [{'value': '1117', 'groupId': 'BG000'}, {'value': '1102', 'groupId': 'BG001'}, {'value': '2219', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received any influenza vaccination within the past 3 years', 'classes': [{'categories': [{'measurements': [{'value': '1210', 'groupId': 'BG000'}, {'value': '1200', 'groupId': 'BG001'}, {'value': '2410', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Reaction from vaccine within the past 3 years', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '2654 participants were randomized at a 1:1 ratio into 1 of 2 vaccine groups. Both groups were stratified by site, age (65 to \\< 75 and ≥ 75 years), and history of prior year receipt of the 2018-2019 influenza vaccine. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-31', 'size': 1050713, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-10T12:53', 'hasProtocol': True}, {'date': '2019-11-01', 'size': 460110, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-08T20:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2654}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2019-10-07', 'resultsFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-11', 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)', 'timeFrame': 'Day 28', 'description': 'Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28'}, {'measure': 'Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants', 'timeFrame': 'Day 0 - Day 28', 'description': 'Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28'}, {'measure': 'Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)', 'timeFrame': 'Day 0 - Day 6', 'description': 'Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).'}, {'measure': 'Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)', 'timeFrame': 'Day 0 - Day 364', 'description': 'Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection.'}, {'measure': 'Number of Subjects With MAAEs, SAEs, SNMCs', 'timeFrame': 'Day 0 - Day 27', 'description': 'Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.'}], 'secondaryOutcomes': [{'measure': 'HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)', 'timeFrame': 'Day 0 - Day 28', 'description': 'Homologous influenza strains and 1 antigenically drifted strain expressed as GMT'}, {'measure': 'HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)', 'timeFrame': 'Day 28 - 364', 'description': 'Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR.'}, {'measure': 'Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain', 'timeFrame': 'Day 28 - Day 364', 'description': 'Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR).'}, {'measure': 'Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR', 'timeFrame': 'Day 28', 'description': 'Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'referencesModule': {'references': [{'pmid': '34563277', 'type': 'DERIVED', 'citation': 'Shinde V, Cho I, Plested JS, Agrawal S, Fiske J, Cai R, Zhou H, Pham X, Zhu M, Cloney-Clark S, Wang N, Zhou B, Lewis M, Price-Abbott P, Patel N, Massare MJ, Smith G, Keech C, Fries L, Glenn GM. Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial. Lancet Infect Dis. 2022 Jan;22(1):73-84. doi: 10.1016/S1473-3099(21)00192-4. Epub 2021 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States at approximately 19 clinical sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinically-stable adult male or female, ≥ 65 years of age. Subjects may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:\n\n * Ambulatory status, living independently in the community or in a residential facility providing minimal assistance (eg, meal preparation and transport),\n * Absence of changes in medical therapy within 1 month due to treatment failure or toxicity,\n * Absence of medical events qualifying as serious adverse events within the prior 2 months, and\n * Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.\n2. Willing and able to give informed consent prior to trial enrollment, and\n3. Living in the community and able to attend trial visits, comply with trial requirements, and provide timely, reliable, and complete reports of adverse events.\n\nExclusion Criteria:\n\n1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of study vaccination.\n2. Participation in any previous Novavax influenza vaccine clinical trial(s).\n3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of Fluzone Quadrivalent or polysorbate 80.\n4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.\n5. Received any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination.\n6. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.\n7. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.\n8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine.\n9. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥ 38.0°C, on the planned day of vaccine administration).\n10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).\n11. Known disturbance of coagulation.\n12. Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other substance abuse.'}, 'identificationModule': {'nctId': 'NCT04120194', 'briefTitle': 'Phase 3 Pivotal Trial of NanoFlu™ in Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novavax'}, 'officialTitle': 'A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1™ Adjuvant Against Fluzone® Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age', 'orgStudyIdInfo': {'id': 'qNIV-E-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NanoFlu', 'description': 'NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.', 'interventionNames': ['Biological: NanoFlu']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluzone Quadrivalent', 'description': 'Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.', 'interventionNames': ['Biological: Fluzone Quadrivalent']}], 'interventions': [{'name': 'NanoFlu', 'type': 'BIOLOGICAL', 'otherNames': ['Quad-NIV'], 'description': 'Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.', 'armGroupLabels': ['NanoFlu']}, {'name': 'Fluzone Quadrivalent', 'type': 'BIOLOGICAL', 'description': 'Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.', 'armGroupLabels': ['Fluzone Quadrivalent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'US135', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'US045', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'US013', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'US012', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '83687', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'US032', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'US003', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '20854', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'US138', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'US025', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'US018', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': 'US056', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'facility': 'US017', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'US030', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'US053', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'US044', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29464', 'city': 'Mt. 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