Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-24 @ 3:18 PM
Study NCT ID:
NCT02508194
Status:
TERMINATED
Last Update Posted:
2017-12-26
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialenquiries@medimmune.com', 'phone': '301-398-0000', 'title': 'Judith Falloon, MD', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated due to failure to meet the primary efficacy endpoint.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 (post-dose) through end of Season 1 (approximately 1 year)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.', 'otherNumAtRisk': 948, 'deathsNumAtRisk': 948, 'otherNumAffected': 52, 'seriousNumAtRisk': 948, 'deathsNumAffected': 5, 'seriousNumAffected': 57}, {'id': 'EG001', 'title': 'MEDI7510+IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.', 'otherNumAtRisk': 946, 'deathsNumAtRisk': 946, 'otherNumAffected': 48, 'seriousNumAtRisk': 946, 'deathsNumAffected': 3, 'seriousNumAffected': 64}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 35, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 28, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis relapsing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Infected lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': 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'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Non-hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer stage i', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Squamous cell carcinoma of head and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 948, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '935', 'groupId': 'OG000'}, {'value': '931', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.1', 'ciLowerLimit': '-106.9', 'ciUpperLimit': '44.3', 'estimateComment': 'The CI was estimated by an exact conditional method.', 'groupDescription': '2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = (\\[1 - relative risk (RR)\\] \\*100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (\\>) 0% would demonstrate the efficacy of MEDI7510.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 after dosing through end of surveillance period (approximately 7 months)', 'description': 'ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: All participants in the as-treated population (ATP) who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '935', 'groupId': 'OG000'}, {'value': '931', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 after dosing through end of surveillance period (approximately 7 months)', 'description': 'Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '944', 'groupId': 'OG000'}, {'value': '940', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.39', 'groupId': 'OG000', 'lowerLimit': '78.91', 'upperLimit': '88.12'}, {'value': '77.96', 'groupId': 'OG001', 'lowerLimit': '73.66', 'upperLimit': '82.50'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '926', 'groupId': 'OG000'}, {'value': '924', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.05', 'groupId': 'OG000', 'lowerLimit': '75.68', 'upperLimit': '84.68'}, {'value': '999.03', 'groupId': 'OG001', 'lowerLimit': '944.40', 'upperLimit': '1056.81'}]}]}, {'title': 'End of Season 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.95', 'groupId': 'OG000', 'lowerLimit': '75.27', 'upperLimit': '84.93'}, {'value': '370.88', 'groupId': 'OG001', 'lowerLimit': '350.90', 'upperLimit': '391.99'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 29, and End of Season 1 (approximately 1 year)', 'description': 'Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Fragment antigen-binding (F AB) unit/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '926', 'groupId': 'OG000'}, {'value': '924', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '0.98'}, {'value': '12.78', 'groupId': 'OG001', 'lowerLimit': '11.96', 'upperLimit': '13.65'}]}]}, {'title': 'End of Season 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '0.96'}, {'value': '4.60', 'groupId': 'OG001', 'lowerLimit': '4.34', 'upperLimit': '4.88'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Fold Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '926', 'groupId': 'OG000'}, {'value': '924', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.5'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '94.4'}]}]}, {'title': 'End of Season 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '2.7'}, {'value': '65.8', 'groupId': 'OG001', 'lowerLimit': '62.5', 'upperLimit': '69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (\\>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'H1N1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.26', 'groupId': 'OG000', 'lowerLimit': '48.610', 'upperLimit': '60.565'}, {'value': '55.77', 'groupId': 'OG001', 'lowerLimit': '50.066', 'upperLimit': '62.115'}]}]}, {'title': 'H1N1, Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161.26', 'groupId': 'OG000', 'lowerLimit': '146.241', 'upperLimit': '177.823'}, {'value': '155.14', 'groupId': 'OG001', 'lowerLimit': '141.356', 'upperLimit': '170.264'}]}]}, {'title': 'H3N2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.81', 'groupId': 'OG000', 'lowerLimit': '31.224', 'upperLimit': '38.804'}, {'value': '35.99', 'groupId': 'OG001', 'lowerLimit': '32.271', 'upperLimit': '40.136'}]}]}, {'title': 'H3N2, Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '291.73', 'groupId': 'OG000', 'lowerLimit': '260.581', 'upperLimit': '326.604'}, {'value': '269.58', 'groupId': 'OG001', 'lowerLimit': '241.784', 'upperLimit': '300.569'}]}]}, {'title': 'B BRISBANE, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.89', 'groupId': 'OG000', 'lowerLimit': '11.851', 'upperLimit': '14.025'}, {'value': '13.46', 'groupId': 'OG001', 'lowerLimit': '12.357', 'upperLimit': '14.672'}]}]}, {'title': 'B BRISBANE, Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.49', 'groupId': 'OG000', 'lowerLimit': '29.314', 'upperLimit': '36.007'}, {'value': '30.15', 'groupId': 'OG001', 'lowerLimit': '27.334', 'upperLimit': '33.257'}]}]}, {'title': 'B PHUKET, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.42', 'groupId': 'OG000', 'lowerLimit': '10.514', 'upperLimit': '12.402'}, {'value': '11.81', 'groupId': 'OG001', 'lowerLimit': '10.857', 'upperLimit': '12.841'}]}]}, {'title': 'B PHUKET, Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.00', 'groupId': 'OG000', 'lowerLimit': '27.088', 'upperLimit': '33.219'}, {'value': '28.29', 'groupId': 'OG001', 'lowerLimit': '25.526', 'upperLimit': '31.348'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (post-dose) and Day 29 of Season 1', 'description': 'GMT was calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.'}, {'type': 'SECONDARY', 'title': 'Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.97', 'groupId': 'OG000', 'lowerLimit': '2.652', 'upperLimit': '3.329'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '2.501', 'upperLimit': '3.094'}]}]}, {'title': 'H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.42', 'groupId': 'OG000', 'lowerLimit': '7.525', 'upperLimit': '9.421'}, {'value': '7.49', 'groupId': 'OG001', 'lowerLimit': '6.669', 'upperLimit': '8.414'}]}]}, {'title': 'B BRISBANE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.301', 'upperLimit': '2.771'}, {'value': '2.24', 'groupId': 'OG001', 'lowerLimit': '2.068', 'upperLimit': '2.425'}]}]}, {'title': 'B PHUKET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '2.419', 'upperLimit': '2.850'}, {'value': '2.40', 'groupId': 'OG001', 'lowerLimit': '2.217', 'upperLimit': '2.589'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 of Season 1', 'description': 'Geometric mean fold change was calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Fold Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}, {'title': 'H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}]}]}, {'title': 'B BRISBANE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}]}]}, {'title': 'B PHUKET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}, {'value': '30.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29 of Season 1', 'description': 'Seroresponse was defined as a \\>= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.'}, {'type': 'SECONDARY', 'title': 'Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.'}, {'type': 'SECONDARY', 'title': 'Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \\>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.'}, {'type': 'SECONDARY', 'title': 'Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.'}, {'type': 'SECONDARY', 'title': 'Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \\>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Solicited Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '948', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '558', 'groupId': 'OG000'}, {'value': '606', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (post-dose) through Day 7', 'description': 'Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever \\>= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP: Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '948', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (post-dose) through Day 29', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '948', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'OG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'classes': [{'title': 'TEAESIs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'NOCDs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (post-dose) through end of Season 1 (approximately 1 year)', 'description': 'An serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Inactivated Influenza Vaccine (IIV)', 'description': 'Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.'}, {'id': 'FG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '949'}, {'groupId': 'FG001', 'numSubjects': '951'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '897'}, {'groupId': 'FG001', 'numSubjects': '907'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Error in Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Principal Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 1900 participants were randomized and participated in the study at 60 sites in 7 countries.', 'preAssignmentDetails': 'A total of 2,044 participants were screened, of which 144 participants were screen failures and 1900 participants were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '949', 'groupId': 'BG000'}, {'value': '951', 'groupId': 'BG001'}, {'value': '1900', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + IIV', 'description': 'Participants received a single IM injection of placebo (matched with MEDI7510) in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'BG001', 'title': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '68.1', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '68.1', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '587', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '421', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As-treated population (ATP): Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1900}}, 'statusModule': {'whyStopped': 'Year 1 of study completed. No enrollment planned for Year 2 of study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2015-07-22', 'resultsFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-22', 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1', 'timeFrame': 'Day 14 after dosing through end of surveillance period (approximately 7 months)', 'description': 'ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1', 'timeFrame': 'Day 14 after dosing through end of surveillance period (approximately 7 months)', 'description': 'Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.'}, {'measure': 'Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay', 'timeFrame': 'Day 1, Day 29, and End of Season 1 (approximately 1 year)', 'description': 'Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.'}, {'measure': 'Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year.'}, {'measure': 'Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (\\>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year.'}, {'measure': 'Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine', 'timeFrame': 'Day 1 (post-dose) and Day 29 of Season 1', 'description': 'GMT was calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year.'}, {'measure': 'Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine', 'timeFrame': 'Day 29 of Season 1', 'description': 'Geometric mean fold change was calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year.'}, {'measure': 'Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody', 'timeFrame': 'Day 29 of Season 1', 'description': 'Seroresponse was defined as a \\>= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year.'}, {'measure': 'Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.'}, {'measure': 'Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.'}, {'measure': 'Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \\>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.'}, {'measure': 'Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 \\[mean (log2 xi)\\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.'}, {'measure': 'Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \\[mean (log2 yi)\\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.'}, {'measure': 'Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA', 'timeFrame': 'Day 29 and End of Season 1 (approximately 1 year)', 'description': 'Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \\>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.'}, {'measure': 'Number of Participants With Any Solicited Symptoms', 'timeFrame': 'Day 1 (post-dose) through Day 7', 'description': 'Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever \\>= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'Day 1 (post-dose) through Day 29', 'description': 'An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)', 'timeFrame': 'Day 1 (post-dose) through end of Season 1 (approximately 1 year)', 'description': 'An serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RSV', 'Older adults', 'MEDI7510', 'Vaccine', 'Efficacy'], 'conditions': ['Respiratory Syncytial Virus']}, 'referencesModule': {'references': [{'pmid': '36542692', 'type': 'DERIVED', 'citation': 'Chang LA, Phung E, Crank MC, Morabito KM, Villafana T, Dubovsky F, Falloon J, Esser MT, Lin BC, Chen GL, Graham BS, Ruckwardt TJ. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine. Sci Transl Med. 2022 Dec 21;14(676):eade0424. doi: 10.1126/scitranslmed.ade0424. Epub 2022 Dec 21.'}, {'pmid': '29029260', 'type': 'DERIVED', 'citation': 'Falloon J, Yu J, Esser MT, Villafana T, Yu L, Dubovsky F, Takas T, Levin MJ, Falsey AR. An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults. J Infect Dis. 2017 Dec 12;216(11):1362-1370. doi: 10.1093/infdis/jix503.'}]}, 'descriptionModule': {'briefSummary': 'This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.', 'detailedDescription': 'A Phase 2b, double-blind, randomized, and controlled study to evaluate the efficacy of MEDI7510 in approximately 1,900 adult participants, globally, 60 years or older. Participants will be randomized in a 1:1 ratio to receive a single intramuscular dose of each of 2 study vaccines in contralateral arms: MEDI7510 + IIV or placebo + IIV in Season 1.\n\nParticipants who receive MEDI7510 in the Northern Hemisphere will be re-randomized and blinded in Season 2 to receive either MEDI7510 + IIV or placebo + IIV in a 1:1 ratio. Clinical efficacy will not be assessed in Season 2; however the safety of revaccination will be assessed in Season 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 60 years at the time of screening.\n* Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the subject appears likely to be able to remain in follow-up through the end of protocol-specified follow-up.\n* (Season 2): Subject received MEDI7510 and IIV in the Northern Hemisphere in Season 1.\n\nExclusion Criteria:\n\n* History of allergy to any component of the vaccine.\n* Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.\n* History of allergy to or intolerance of IIV.\n* Pregnancy or potential to become pregnant during the study. Females who (1) have had a menstrual period within the 12 months prior to study enrollment or (2) are undergoing any fertility treatment or who plan to undergo fertility treatments during the study period are excluded.\n* History of Guillain-Barré syndrome.\n* Previous vaccination against RSV.\n* History of allergy to eggs in adulthood.\n* History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis, which is acceptable.\n* Immunosuppression caused by disease, including human immunodeficiency virus infection (assessed by history), or medications. Any receipt of oral or intravenous glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular corticosteroids do not disqualify. Expected need for immunosuppressive medications during the follow-up period would disqualify.\n* History of cancer within preceding 5 years other than treated non-melanoma skin cancer, locally-treated cervical cancer or in situ carcinoma of the breast.\n* Receipt of any non-study vaccine within 28 days prior to study dosing or expected receipt of non-study vaccine prior to the Day 29 visit in Season 1.\n* Receipt of any investigational product (IP) in the 90 days prior to randomization or expected receipt of IP during the period of study follow-up.\n* Receipt of immunoglobulins or blood products within 4 months of study dosing (120 days) or expected receipt of immunoglobulins or blood products during the period of study follow-up.\n* Current bleeding or clotting disorder including use of anticoagulants other than drugs with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel, ticagrelor or aspirin).\n* History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the investigator, would affect the subject's safety or compliance with study.\n* (Season 2): Related Grade 3 or 4 adverse event (AE) including Grade 3 or 4 local reaction to either MEDI7510 or IIV, any adverse event of special interest (AESI) for an adjuvanted vaccine, or any related serious adverse event (SAE)."}, 'identificationModule': {'nctId': 'NCT02508194', 'briefTitle': 'A Study to Evaluate the Efficacy of MEDI7510 in Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults', 'orgStudyIdInfo': {'id': 'D4420C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Inactivated Influenza Vaccine (IIV)', 'description': 'Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.', 'interventionNames': ['Biological: IIV', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI7510 + IIV', 'description': 'Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.', 'interventionNames': ['Biological: MEDI7510', 'Biological: IIV']}], 'interventions': [{'name': 'MEDI7510', 'type': 'BIOLOGICAL', 'description': 'RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant', 'armGroupLabels': ['MEDI7510 + IIV']}, {'name': 'IIV', 'type': 'BIOLOGICAL', 'description': 'Marketed Inactivated Influenza Vaccine', 'armGroupLabels': ['MEDI7510 + IIV', 'Placebo + Inactivated Influenza Vaccine (IIV)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Sterile Saline', 'armGroupLabels': ['Placebo + Inactivated Influenza Vaccine (IIV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95864', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94108', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80127', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '32159', 'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '67010', 'city': 'Augusta', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.68668, 'lon': -96.9767}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.56338, 'lon': -91.59432}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68005', 'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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