Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05608005
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2022-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
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': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days', 'description': 'The Safety analysis set included all participants who had received at least 1 study vaccine.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 82, 'seriousNumAtRisk': 243, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.', 'otherNumAtRisk': 246, 'deathsNumAtRisk': 246, 'otherNumAffected': 82, 'seriousNumAtRisk': 246, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 23, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 66, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 60, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 43, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 41, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 44, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Stress Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Clostridium Difficile Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': "Fournier's Gangrene", 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia Respiratory Syncytial Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bone Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fractured Coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Traumatic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac Myxoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac Valve Fibroelastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fallopian Tube Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Embolic Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Giant Cell Arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.74', 'groupId': 'OG000', 'lowerLimit': '5.44', 'upperLimit': '6.06'}, {'value': '5.61', 'groupId': 'OG001', 'lowerLimit': '5.34', 'upperLimit': '5.90'}, {'value': '5.28', 'groupId': 'OG002', 'lowerLimit': '5.10', 'upperLimit': '5.47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '14.6'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '15.5'}, {'value': '5.80', 'groupId': 'OG002', 'lowerLimit': '5.37', 'upperLimit': '6.27'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 43', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.15'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.998', 'upperLimit': '1.11'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.981', 'upperLimit': '1.08'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 22', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.39', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '2.78'}, {'value': '2.52', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '2.91'}, {'value': '1.13', 'groupId': 'OG002', 'lowerLimit': '1.05', 'upperLimit': '1.23'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 43', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.969', 'upperLimit': '1.05'}, {'value': '0.966', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.01'}, {'value': '0.990', 'groupId': 'OG002', 'lowerLimit': '0.951', 'upperLimit': '1.03'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 202', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 202 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.998', 'groupId': 'OG000', 'lowerLimit': '0.961', 'upperLimit': '1.04'}, {'value': '0.976', 'groupId': 'OG001', 'lowerLimit': '0.927', 'upperLimit': '1.03'}, {'value': '0.978', 'groupId': 'OG002', 'lowerLimit': '0.943', 'upperLimit': '1.01'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 387', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 387 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.0'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The seroconversion was defined as titer \\<10 on Day 1 and post-injection titer \\>=40 on Day 22 or Day 43; or defined as titer \\>=10 on Day 1 and a \\>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '28.9'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '28.9'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43', 'description': 'The seroconversion was defined as titer \\<10 on Day 1 and post-injection titer \\>=40 on Day 22 or Day 43; or defined as titer \\>=10 on Day 1 and a \\>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '29.3'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '29.4'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 202', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 387', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.7'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.7'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '11.0'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '10.4'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '53.6'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '59.0'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '19.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '6.7'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '5.4'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 202', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '5.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 387', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.23', 'groupId': 'OG000', 'lowerLimit': '6.61', 'upperLimit': '7.91'}, {'value': '6.85', 'groupId': 'OG001', 'lowerLimit': '6.31', 'upperLimit': '7.45'}, {'value': '6.88', 'groupId': 'OG002', 'lowerLimit': '6.04', 'upperLimit': '7.84'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Neutralization Test Antibody Titer at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '32.6'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '30.4'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '9.31', 'upperLimit': '14.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '1.09', 'upperLimit': '1.35'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '1.25'}, {'value': '1.09', 'groupId': 'OG002', 'lowerLimit': '0.923', 'upperLimit': '1.28'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 22', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.51', 'groupId': 'OG000', 'lowerLimit': '3.66', 'upperLimit': '5.55'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '3.59', 'upperLimit': '5.14'}, {'value': '1.86', 'groupId': 'OG002', 'lowerLimit': '1.46', 'upperLimit': '2.38'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 43', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.34'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.30'}, {'value': '0.856', 'groupId': 'OG002', 'lowerLimit': '0.735', 'upperLimit': '0.997'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 202', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 202 are reported.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.35'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '1.32'}, {'value': '0.909', 'groupId': 'OG002', 'lowerLimit': '0.792', 'upperLimit': '1.04'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 387', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 387 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'title': 'Antibody Titer >=1:20', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '14.6'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '11.5'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '16.4'}]}]}, {'title': 'Antibody Titer >=1:40', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.0'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Antibody Titer >=1:80', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'title': 'Antibody Titer >=1:20', 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '48.1', 'upperLimit': '61.5'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '49.2', 'upperLimit': '62.4'}, {'value': '29.2', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '41.1'}]}]}, {'title': 'Antibody Titer >=1:40', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '29.4', 'upperLimit': '42.4'}, {'value': '35.1', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '41.6'}, {'value': '11.1', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '20.7'}]}]}, {'title': 'Antibody Titer >=1:80', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '28.3'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '21.4'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'title': '>=2 fold increase', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '28.1'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '22.7'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '10.5', 'upperLimit': '29.0'}]}]}, {'title': '>=4 fold increase', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '12.1'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '9.9'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '12.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'title': '>=2 fold increase', 'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '70.8'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '77.2'}, {'value': '48.6', 'groupId': 'OG002', 'lowerLimit': '36.7', 'upperLimit': '60.7'}]}]}, {'title': '>=4 fold increase', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '57.9'}, {'value': '51.9', 'groupId': 'OG001', 'lowerLimit': '45.3', 'upperLimit': '58.5'}, {'value': '26.4', 'groupId': 'OG002', 'lowerLimit': '16.7', 'upperLimit': '38.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '19.3'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '20.7'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '10.5', 'upperLimit': '29.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '33.0'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '30.2'}, {'value': '26.3', 'groupId': 'OG002', 'lowerLimit': '16.9', 'upperLimit': '37.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '63.2', 'upperLimit': '75.6'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '81.5'}, {'value': '54.2', 'groupId': 'OG002', 'lowerLimit': '42.0', 'upperLimit': '66.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '19.9', 'upperLimit': '32.2'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '31.4'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '14.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 202', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '30.6'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '33.0'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '18.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 387', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 minutes after each vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who had received at least 1 study vaccine.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited Injection Site Reactions and Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'title': 'Solicited injection site reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Solicited systemic reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after each vaccination', 'description': 'An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. An injection/administration site reaction is an AR at and around the injection/administration site of the investigational medical product. Systemic ARs are all ARs that are not injection or administration site reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who had received at least 1 study vaccine. Only participants analyzed for specific parameter are reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days after each vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who had received at least 1 study vaccine.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'OG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'classes': [{'title': 'Any SAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any AESI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any MAAE', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days', 'description': "An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who had received at least 1 study vaccine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 microgram (mcg) + MF59 adjuvant intramuscular (IM) injection once daily on Days 1 and 22.'}, {'id': 'FG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'FG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '246'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Participants were not vaccinated or withdrew for other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 16 centers in the United States between 03 November 2022 and 13 February 2024.', 'preAssignmentDetails': 'A total of 581 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '573', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Panblok H7 (7.5 mcg) + MF59', 'description': 'Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'BG001', 'title': 'Group 2: Panblok H7 (15 mcg) + MF59', 'description': 'Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.'}, {'id': 'BG002', 'title': 'Group 3: Panblok H7 (45 mcg) Unadjuvanted', 'description': 'Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '17.1', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '15.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '274', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '408', 'groupId': 'BG003'}]}, {'title': 'Multiple origin', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety analysis set included all participants who had received at least 1 study vaccine.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-14', 'size': 673000, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-28T05:37', 'hasProtocol': True}, {'date': '2022-05-27', 'size': 353271, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-28T05:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Modified double-blind:\n\n* Investigators and study staff who conduct the safety assessment, laboratory personnel who analyze the blood samples, Sponsor's personnel and study Team members, and the participant will not know which study dose is administered\n* Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study dose is administered"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible participants (18-64 years of age and ≥65 years of age) will be randomized in a 3:3:1 ratio to receive 2 doses, 21 days apart, by intramuscular (IM) route of either Panblok H7+MF59 (dose 1), Panblok H7+MF59 (dose 2), or unadjuvanted Panblok H7 (dose 3) at D01.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 581}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2024-02-15', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2022-10-20', 'resultsFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2022-11-04', 'dispFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-01-28', 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22', 'timeFrame': 'Day 22', 'description': 'The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43', 'timeFrame': 'Day 43', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22', 'timeFrame': 'Days 1 and 22', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43', 'timeFrame': 'Days 1 and 43', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202', 'timeFrame': 'Days 1 and 202', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387', 'timeFrame': 'Days 1 and 387', 'description': 'The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22', 'timeFrame': 'Day 22', 'description': 'The seroconversion was defined as titer \\<10 on Day 1 and post-injection titer \\>=40 on Day 22 or Day 43; or defined as titer \\>=10 on Day 1 and a \\>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43', 'timeFrame': 'Day 43', 'description': 'The seroconversion was defined as titer \\<10 on Day 1 and post-injection titer \\>=40 on Day 22 or Day 43; or defined as titer \\>=10 on Day 1 and a \\>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1', 'timeFrame': 'Day 1', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22', 'timeFrame': 'Day 22', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43', 'timeFrame': 'Day 43', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202', 'timeFrame': 'Day 202', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387', 'timeFrame': 'Day 387', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1', 'timeFrame': 'Day 1', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22', 'timeFrame': 'Day 22', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43', 'timeFrame': 'Day 43', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202', 'timeFrame': 'Day 202', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387', 'timeFrame': 'Day 387', 'description': 'The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean of Neutralization Test Antibody Titer at Day 43', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22', 'timeFrame': 'Days 1 and 22', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43', 'timeFrame': 'Days 1 and 43', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202', 'timeFrame': 'Days 1 and 202', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387', 'timeFrame': 'Days 1 and 387', 'description': 'The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.'}, {'measure': 'Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1', 'timeFrame': 'Day 1', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22', 'timeFrame': 'Day 22', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43', 'timeFrame': 'Day 43', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202', 'timeFrame': 'Day 202', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}, {'measure': 'Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387', 'timeFrame': 'Day 387', 'description': 'The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)', 'timeFrame': 'Up to 30 minutes after each vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions and Systemic Reactions', 'timeFrame': 'Up to 7 days after each vaccination', 'description': 'An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. An injection/administration site reaction is an AR at and around the injection/administration site of the investigational medical product. Systemic ARs are all ARs that are not injection or administration site reactions.'}, {'measure': 'Number of Participants With Unsolicited AEs', 'timeFrame': 'Up to 21 days after each vaccination', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)', 'timeFrame': 'From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days', 'description': "An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza', 'Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=25367&tenant=MT_SNY_9011', 'label': 'VAM00001 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study.\n\nThe purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age.\n\nThe study duration for each participant will be approximately 13 months.', 'detailedDescription': 'The study duration for each participant will be approximately 13 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older on the day of inclusion\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination\n* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:\n\nIs of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.\n\nOR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration.\n\n* A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention\n* Informed consent form has been signed and dated\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances\n* Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based on investigator\'s judgement\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion (1)\n\n (1) Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection\n* Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of study intervention administration in the absence of therapy, and participants who have a history of neoplastic disease and who have been disease-free for ≥ 5 years)\n* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided\n* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion\n* Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at least 2 weeks after Visit 2\n* Previous vaccination against H7N9 with an investigational vaccine\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months\n* Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study\n* Personal or family history of Guillain-Barré syndrome\n* Self-reported seropositivity for Hepatitis B antigen or Hepatitis C\n\n"The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."'}, 'identificationModule': {'nctId': 'NCT05608005', 'briefTitle': 'Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older', 'orgStudyIdInfo': {'id': 'VAM00001'}, 'secondaryIdInfos': [{'id': 'U1111-1256-9115', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '2 doses, 21 days apart, of Panblok H7 dose 1 + MF59', 'interventionNames': ['Biological: Panblok + MF59 Dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '2 doses, 21 days apart, of Panblok H7 dose 2 + MF59', 'interventionNames': ['Biological: Panblok + MF59 Dose 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': '2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted', 'interventionNames': ['Biological: Unadjuvanted Panblok Dose 3']}], 'interventions': [{'name': 'Panblok + MF59 Dose 1', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: suspension for injection Route of administration: intramuscular', 'armGroupLabels': ['Group 1']}, {'name': 'Panblok + MF59 Dose 2', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: suspension for injection Route of administration: intramuscular', 'armGroupLabels': ['Group 2']}, {'name': 'Unadjuvanted Panblok Dose 3', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: liquid for injection Route of administration: intramuscular', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Centricity Research-Mesa Site Number : 8400006', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'Velocity Clinical Research-Hallandale Beach Site Number : 8400026', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America Site Number : 8400024', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Associates, LLC Site Number : 8400008', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'country': 'United States', 'facility': 'St Johns Center for Clinical Research Site Number : 8400021', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Velocity Clinical Research Valparaiso Site Number : 8400007', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Velocity Clinical Research Site Number : 8400027', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'M3 Wake Research Inc Site Number : 8400010', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians Site Number : 8400015', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15243', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians, Inc. Site Number : 8400002', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Velocity Clinical Research Anderson Site Number : 8400016', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'WR-ClinSearch, LLC Site Number : 8400003', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research Site Number : 8400019', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'JBR Clinical Research Site Number : 8400005', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Foothill Family Research-South Site Number : 8400009', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MCM Vaccines B.V.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}