Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:38 PM
Study NCT ID:
NCT06060457
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2023-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722749', 'term': 'mRNA-1345 respiratory syncytial virus vaccine'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'WeCareClinicalTrials@modernatx.com', 'phone': '+1-866-663-3762', 'title': 'Moderna WeCare Team', 'organization': 'ModernaTX, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and serious adverse events were collected Day 1 up to Day 202. Other (not including serious) unsolicited adverse events were collected up to 21 days after each study injection (that is, Day 1 up to Day 21 for the first injection and Day 22 up to Day 43 for the second injection).', 'description': 'All-cause mortality based on randomization set. SAEs and other (not including serious) AEs based on safety set (all randomized participants who received any study vaccination). Participants included in treatment arm corresponding to study drug they actually received. Per prespecified analysis, all-cause mortality, SAE, and other (not including serious) AE data were collected by arm assignment of "Fluzone HD + mRNA-1345 Followed by Placebo" or "Fluzone HD + Placebo Followed by mRNA-1345".', 'eventGroups': [{'id': 'EG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.', 'otherNumAtRisk': 947, 'deathsNumAtRisk': 950, 'otherNumAffected': 0, 'seriousNumAtRisk': 947, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.', 'otherNumAtRisk': 946, 'deathsNumAtRisk': 950, 'otherNumAffected': 0, 'seriousNumAtRisk': 946, 'deathsNumAffected': 2, 'seriousNumAffected': 33}], 'seriousEvents': [{'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Septic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chronic lymphocytic leukaemia stage 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, '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 25.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, '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 25.0'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, '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 25.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Central cord syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dislocation of vertebra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 947, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 946, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '945', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '689', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after Day 1 injection', 'description': 'Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Day 1 Solicited Safety Set included all randomized participants who received any study intervention on Day 1 and contributed any solicited ARs data from the time of study injection on Day 1 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '919', 'groupId': 'OG000'}, {'value': '910', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '557', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after Day 22 injection', 'description': 'Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Day 22 Solicited Safety Set included all randomized participants who received any study intervention on Day 22 and contributed any solicited ARs data from the time of study injection on Day 22 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days after Day 1 injection', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \\[PT\\]/partial thromboplastin time \\[PTT\\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days after Day 22 injection', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or PT/PTT) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'MAAEs', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 202', 'description': 'A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor\'s product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'RSV-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11800.26', 'groupId': 'OG000', 'lowerLimit': '11063.69', 'upperLimit': '12585.87'}, {'value': '18874.12', 'groupId': 'OG001', 'lowerLimit': '17670.37', 'upperLimit': '20159.87'}]}]}, {'title': 'RSV-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4197.74', 'groupId': 'OG000', 'lowerLimit': '3949.53', 'upperLimit': '4461.54'}, {'value': '6579.15', 'groupId': 'OG001', 'lowerLimit': '6178.21', 'upperLimit': '7006.11'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.625', 'ciLowerLimit': '0.570', 'ciUpperLimit': '0.686', 'groupDescription': 'RSV-A: Arm 1 versus Arm 2', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.638', 'ciLowerLimit': '0.584', 'ciUpperLimit': '0.697', 'groupDescription': 'RSV-B: Arm 1 versus Arm 2', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22 (for Arm 1) and Day 43 (for Arm 2)', 'description': 'Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The Per-protocol (PP) Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category."}, {'type': 'PRIMARY', 'title': 'GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'Influenza A H1N1 Antibody', 'categories': [{'measurements': [{'value': '108.11', 'groupId': 'OG000', 'lowerLimit': '99.76', 'upperLimit': '117.15'}, {'value': '124.15', 'groupId': 'OG001', 'lowerLimit': '114.49', 'upperLimit': '134.62'}]}]}, {'title': 'Influenza A H3N2 Antibody', 'categories': [{'measurements': [{'value': '198.53', 'groupId': 'OG000', 'lowerLimit': '183.61', 'upperLimit': '214.67'}, {'value': '228.83', 'groupId': 'OG001', 'lowerLimit': '211.50', 'upperLimit': '247.58'}]}]}, {'title': 'Influenza B Austria Antibody', 'categories': [{'measurements': [{'value': '105.32', 'groupId': 'OG000', 'lowerLimit': '98.34', 'upperLimit': '112.80'}, {'value': '118.27', 'groupId': 'OG001', 'lowerLimit': '110.37', 'upperLimit': '126.74'}]}]}, {'title': 'Influenza B Phuket Antibody', 'categories': [{'measurements': [{'value': '33.17', 'groupId': 'OG000', 'lowerLimit': '31.28', 'upperLimit': '35.17'}, {'value': '34.97', 'groupId': 'OG001', 'lowerLimit': '32.97', 'upperLimit': '37.10'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'RSV-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '67.8'}, {'value': '78.2', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '80.9'}]}]}, {'title': 'RSV-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '52.0'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '58.5', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)', 'description': 'Seroresponse at a participant level was defined as a change from below the LLOQ to equal or above 4 \\* LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'RSV-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.49', 'groupId': 'OG000', 'lowerLimit': '6.03', 'upperLimit': '6.99'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '9.25', 'upperLimit': '10.82'}]}]}, {'title': 'RSV-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.08', 'groupId': 'OG000', 'lowerLimit': '3.81', 'upperLimit': '4.36'}, {'value': '5.92', 'groupId': 'OG001', 'lowerLimit': '5.48', 'upperLimit': '6.39'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22 (for Arm 1) or Day 43 (for Arm 2)', 'description': '95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'RSV-A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'OG000'}, {'value': '858', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '87.6'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '91.3', 'upperLimit': '94.8'}]}]}, {'title': 'RSV-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '78.2'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '85.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22 (Arm 1) or Day 43 (Arm 2)', 'description': '≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \\* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion, as Measured by HAI Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'Influenza A H1N1 Antibody', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '59.3'}, {'value': '59.0', 'groupId': 'OG001', 'lowerLimit': '55.6', 'upperLimit': '62.2'}]}]}, {'title': 'Influenza A H3N2 Antibody', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '63.5'}, {'value': '65.8', 'groupId': 'OG001', 'lowerLimit': '62.6', 'upperLimit': '68.9'}]}]}, {'title': 'Influenza B Austria Antibody', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000', 'lowerLimit': '52.2', 'upperLimit': '58.8'}, {'value': '59.1', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '62.4'}]}]}, {'title': 'Influenza B Phuket Antibody', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '34.8'}, {'value': '32.8', 'groupId': 'OG001', 'lowerLimit': '29.7', 'upperLimit': '36.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Seroconversion at a participant level was defined as a titer ≥1:40 if baseline is \\< 1:10 or at least a 4-fold increase from baseline if baseline was ≥1:10. Antibody values reported as below LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'GMFR of Serum Ab Level, as Measured by HAI Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '880', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'Influenza A H1N1 Antibody', 'categories': [{'measurements': [{'value': '5.21', 'groupId': 'OG000', 'lowerLimit': '4.76', 'upperLimit': '5.71'}, {'value': '5.78', 'groupId': 'OG001', 'lowerLimit': '5.25', 'upperLimit': '6.36'}]}]}, {'title': 'Influenza A H3N2 Antibody', 'categories': [{'measurements': [{'value': '6.20', 'groupId': 'OG000', 'lowerLimit': '5.64', 'upperLimit': '6.82'}, {'value': '7.16', 'groupId': 'OG001', 'lowerLimit': '6.49', 'upperLimit': '7.89'}]}]}, {'title': 'Influenza B Austria Antibody', 'categories': [{'measurements': [{'value': '4.87', 'groupId': 'OG000', 'lowerLimit': '4.48', 'upperLimit': '5.30'}, {'value': '5.64', 'groupId': 'OG001', 'lowerLimit': '5.17', 'upperLimit': '6.16'}]}]}, {'title': 'Influenza B Phuket Antibody', 'categories': [{'measurements': [{'value': '2.73', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '2.90'}, {'value': '2.88', 'groupId': 'OG001', 'lowerLimit': '2.70', 'upperLimit': '3.07'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': '95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The PP Set included all randomized participants who received the assigned study intervention dose according to protocol, complied with immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '946', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'OG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Deaths related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 202', 'description': 'A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone High Dose (HD) + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'FG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '950'}, {'groupId': 'FG001', 'numSubjects': '950'}]}, {'type': 'Received Day 1 Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '946'}, {'groupId': 'FG001', 'numSubjects': '947'}]}, {'type': 'Received Day 22 Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '919'}, {'groupId': 'FG001', 'numSubjects': '911'}]}, {'type': 'Safety Set', 'comment': 'All randomized participants who received any study intervention. Participants were included in the treatment arm corresponding to the study drug they actually received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '947'}, {'comment': "1 participant received wrong injection (Fluzone HD + mRNA-1345 Followed by Placebo) instead of receiving 'Fluzone HD + Placebo Followed by mRNA-1345'.", 'groupId': 'FG001', 'numSubjects': '946'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '914'}, {'groupId': 'FG001', 'numSubjects': '909'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Serious Adverse Reaction (SAR)/Reactogenicity Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Other Than Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'BG000'}, {'value': '950', 'groupId': 'BG001'}, {'value': '1900', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluzone HD + mRNA-1345 Followed by Placebo', 'description': 'Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22.'}, {'id': 'BG001', 'title': 'Fluzone HD + Placebo Followed by mRNA-1345', 'description': 'Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'spread': '4.80', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '4.80', 'groupId': 'BG001'}, {'value': '70.7', 'spread': '4.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '548', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1078', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '822', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '728', 'groupId': 'BG000'}, {'value': '722', 'groupId': 'BG001'}, {'value': '1450', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '735', 'groupId': 'BG000'}, {'value': '738', 'groupId': 'BG001'}, {'value': '1473', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "The Randomized Set included all participants who were randomized in the study, regardless of the participant's treatment status in the study."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-11', 'size': 1281728, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-05T13:22', 'hasProtocol': True}, {'date': '2023-11-10', 'size': 1509969, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-05T13:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2023-09-23', 'resultsFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2023-09-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-10', 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Deaths Related to Study Drug', 'timeFrame': 'Day 1 through Day 202', 'description': 'A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection', 'timeFrame': 'Within 7 days after Day 1 injection', 'description': 'Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.'}, {'measure': 'Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection', 'timeFrame': 'Within 7 days after Day 22 injection', 'description': 'Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.'}, {'measure': 'Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection', 'timeFrame': 'Up to 21 days after Day 1 injection', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \\[PT\\]/partial thromboplastin time \\[PTT\\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.'}, {'measure': 'Number of Participants With Unsolicited AEs Up to 21 Days After Day 22 Injection', 'timeFrame': 'Up to 21 days after Day 22 injection', 'description': 'An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or PT/PTT) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.'}, {'measure': 'Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation', 'timeFrame': 'Day 1 through Day 202', 'description': 'A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor\'s product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.'}, {'measure': 'Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAbs)', 'timeFrame': 'Day 22 (for Arm 1) and Day 43 (for Arm 2)', 'description': 'Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.'}, {'measure': 'GMT of Serum Anti-Hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay', 'timeFrame': 'Day 22', 'description': 'Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Seroresponse for RSV-A and RSV-B nAbs, as Measured by HAI Assay', 'timeFrame': 'Baseline to Day 22 (for Arm 1) or Day 43 (for Arm 2)', 'description': 'Seroresponse at a participant level was defined as a change from below the LLOQ to equal or above 4 \\* LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.'}, {'measure': 'Geometric Mean Fold-Rise (GMFR) of Postinjection RSV-A and RSV-B nAbs Antibodies for Influenza, as Measured by HAI Assay', 'timeFrame': 'Day 22 (for Arm 1) or Day 43 (for Arm 2)', 'description': '95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.'}, {'measure': 'Percentage of Participants With ≥2-fold Increase in RSV-A and RSV-B nAbs', 'timeFrame': 'Day 22 (Arm 1) or Day 43 (Arm 2)', 'description': '≥2-fold increase from baseline at participant level was defined as a change from below the LLOQ to equal or above 2 \\* LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 for RSV-B.'}, {'measure': 'Percentage of Participants With Seroconversion, as Measured by HAI Assay', 'timeFrame': 'Day 22', 'description': 'Influenza A strains included H1N1 and H3N2 and influenza B strains included Austria and Phuket strains. Seroconversion at a participant level was defined as a titer ≥1:40 if baseline is \\< 1:10 or at least a 4-fold increase from baseline if baseline was ≥1:10. Antibody values reported as below LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B.'}, {'measure': 'GMFR of Serum Ab Level, as Measured by HAI Assay', 'timeFrame': 'Day 22', 'description': '95% CI for GMFR was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Viral Diseases', 'Messenger RNA', 'Moderna', 'mRNA-1345', 'Respiratory syncytial virus', 'Vaccines', 'RSV Vaccine'], 'conditions': ['Respiratory Syncytial Virus']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:\n\n * Absence of changes in medical therapy within 60 days of Day 1 due to treatment failure or toxicity,\n * Absence of serious or significant medical events within 30 days of Day 1, and\n * Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.\n* A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.\n\nKey Exclusion Criteria:\n\n* Close contact with someone with laboratory-confirmed influenza and/or RSV infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.\n* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.\n* Participant has tested positive for influenza or RSV by local health authority-approved testing methods ≤6 months prior to Day 1.\n* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1 and Day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections.\n* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to Day 1.\n* Participant has received any RSV vaccine (authorized/approved by local health agency or investigational) prior to Day 1.\n\nNote: Other protocol-defined inclusion and/or exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06060457', 'briefTitle': 'A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Observer-Blind Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, When Coadministered With a High-Dose, Quadrivalent Seasonal Influenza Vaccine in Adults ≥65 Years of Age', 'orgStudyIdInfo': {'id': 'mRNA-1345-P304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluzone HD + mRNA-1345', 'description': 'Participants will receive Fluzone HD + mRNA-1345 by intramuscular (IM) injection on Day 1 followed by placebo by IM injection on Day 22.', 'interventionNames': ['Biological: Placebo', 'Biological: mRNA-1345', 'Biological: Fluzone HD']}, {'type': 'EXPERIMENTAL', 'label': 'Fluzone HD Followed by mRNA-1345', 'description': 'Participants will receive Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22.', 'interventionNames': ['Biological: Placebo', 'Biological: mRNA-1345', 'Biological: Fluzone HD']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Fluzone HD + mRNA-1345', 'Fluzone HD Followed by mRNA-1345']}, {'name': 'mRNA-1345', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection', 'armGroupLabels': ['Fluzone HD + mRNA-1345', 'Fluzone HD Followed by mRNA-1345']}, {'name': 'Fluzone HD', 'type': 'BIOLOGICAL', 'description': 'Suspension for injection', 'armGroupLabels': ['Fluzone HD + 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