Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-28 @ 2:43 AM
Study NCT ID:
NCT05827068
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722747', 'term': 'mRNA-1010 influenza vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@modernatx.com', 'phone': '1-877-777-7187', 'title': 'Moderna Clinical Trials Support Center', 'organization': 'ModernaTX, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to the end of study (Day 181)', 'description': 'The all-cause mortality was based on the randomization set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received one dose of study vaccination. Participants were included in the vaccination group corresponding to what they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'mRNA-1010 50 ug', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 2, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'mRNA-1010.2 50 ug', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 101, 'otherNumAffected': 6, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'mRNA-1010.3 50 ug', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 98, 'otherNumAffected': 1, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'mRNA-1011.1 50 ug', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'mRNA-1011.2 40 ug', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 6, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'mRNA-1012.1 50 ug', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 100, 'otherNumAffected': 1, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'mRNA-1012.1 62.5 ug', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 101, 'otherNumAffected': 1, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mitral valve prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '97', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'OG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'OG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'OG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'OG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'OG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'OG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'classes': [{'title': 'Any', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '85', 'groupId': 'OG005'}, {'value': '74', 'groupId': 'OG006'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post-vaccination', 'description': 'Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Solicited Safety Set included all randomly assigned participants who received the study vaccination and contributed any solicited AR data. Participants were included in the vaccination group corresponding to what they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '98', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'OG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'OG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'OG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'OG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'OG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'OG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days post-vaccination', '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. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomly assigned participants who received the study vaccination. Participants were included in the vaccination group corresponding to what they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '102', 'groupId': 'OG005'}, {'value': '98', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'OG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'OG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'OG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'OG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'OG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'OG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'MAAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 181 (end of study [EOS])', 'description': '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/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up) and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomly assigned participants who received the study vaccination. Participants were included in the vaccination group corresponding to what they actually received.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '88', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'OG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'OG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'OG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'OG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'OG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'OG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'classes': [{'title': 'Influenza A H1N1 Antibody', 'categories': [{'measurements': [{'value': '197.9', 'groupId': 'OG000', 'lowerLimit': '156.37', 'upperLimit': '250.35'}, {'value': '214.3', 'groupId': 'OG001', 'lowerLimit': '174.66', 'upperLimit': '262.85'}, {'value': '204.3', 'groupId': 'OG002', 'lowerLimit': '163.67', 'upperLimit': '255.05'}, {'value': '189.1', 'groupId': 'OG003', 'lowerLimit': '149.05', 'upperLimit': '239.98'}, {'value': '207.2', 'groupId': 'OG004', 'lowerLimit': '165.10', 'upperLimit': '259.97'}, {'value': '188.9', 'groupId': 'OG005', 'lowerLimit': '154.11', 'upperLimit': '231.47'}, {'value': '216.7', 'groupId': 'OG006', 'lowerLimit': '174.91', 'upperLimit': '268.52'}]}]}, {'title': 'Influenza A H3N2 (Darwin) Antibody', 'categories': [{'measurements': [{'value': '122.3', 'groupId': 'OG000', 'lowerLimit': '99.84', 'upperLimit': '149.93'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '63.87', 'upperLimit': '98.62'}, {'value': '83.3', 'groupId': 'OG002', 'lowerLimit': '69.50', 'upperLimit': '99.76'}, {'value': '117.8', 'groupId': 'OG003', 'lowerLimit': '95.33', 'upperLimit': '145.44'}, {'value': '138.2', 'groupId': 'OG004', 'lowerLimit': '108.34', 'upperLimit': '176.27'}, {'value': '115.7', 'groupId': 'OG005', 'lowerLimit': '94.61', 'upperLimit': '141.59'}, {'value': '122.0', 'groupId': 'OG006', 'lowerLimit': '98.63', 'upperLimit': '150.86'}]}]}, {'title': 'Influenza A H3N2 (Newcastle) Antibody', 'categories': [{'measurements': [{'value': '130.8', 'groupId': 'OG000', 'lowerLimit': '104.44', 'upperLimit': '163.90'}, {'value': '205.3', 'groupId': 'OG001', 'lowerLimit': '168.20', 'upperLimit': '250.58'}, {'value': '127.2', 'groupId': 'OG002', 'lowerLimit': '106.29', 'upperLimit': '152.10'}, {'value': '178.2', 'groupId': 'OG003', 'lowerLimit': '142.20', 'upperLimit': '223.29'}, {'value': '232.2', 'groupId': 'OG004', 'lowerLimit': '188.10', 'upperLimit': '286.53'}, {'value': '187.4', 'groupId': 'OG005', 'lowerLimit': '151.33', 'upperLimit': '232.06'}, {'value': '224.5', 'groupId': 'OG006', 'lowerLimit': '179.54', 'upperLimit': '280.60'}]}]}, {'title': 'Influenza A H3N2 (Hong Kong) Antibody', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000', 'lowerLimit': '59.36', 'upperLimit': '90.80'}, {'value': '82.2', 'groupId': 'OG001', 'lowerLimit': '67.36', 'upperLimit': '100.33'}, {'value': '97.1', 'groupId': 'OG002', 'lowerLimit': '82.28', 'upperLimit': '114.53'}, {'value': '86.9', 'groupId': 'OG003', 'lowerLimit': '68.07', 'upperLimit': '111.03'}, {'value': '111.8', 'groupId': 'OG004', 'lowerLimit': '90.22', 'upperLimit': '138.50'}, {'value': '105.0', 'groupId': 'OG005', 'lowerLimit': '85.77', 'upperLimit': '128.43'}, {'value': '122.9', 'groupId': 'OG006', 'lowerLimit': '99.89', 'upperLimit': '151.25'}]}]}, {'title': 'Influenza B/ Yamagata Lineage', 'categories': [{'measurements': [{'value': '111.1', 'groupId': 'OG000', 'lowerLimit': '98.52', 'upperLimit': '125.25'}, {'value': '125.2', 'groupId': 'OG001', 'lowerLimit': '106.42', 'upperLimit': '147.30'}, {'value': '118.7', 'groupId': 'OG002', 'lowerLimit': '103.20', 'upperLimit': '136.49'}, {'value': '113.2', 'groupId': 'OG003', 'lowerLimit': '97.59', 'upperLimit': '131.32'}, {'value': '81.6', 'groupId': 'OG004', 'lowerLimit': '71.33', 'upperLimit': '93.38'}, {'value': '77.1', 'groupId': 'OG005', 'lowerLimit': '67.58', 'upperLimit': '87.88'}, {'value': '71.7', 'groupId': 'OG006', 'lowerLimit': '64.20', 'upperLimit': '80.00'}]}]}, {'title': 'Influenza B/ Victoria Lineage', 'categories': [{'measurements': [{'value': '207.7', 'groupId': 'OG000', 'lowerLimit': '179.36', 'upperLimit': '240.54'}, {'value': '234.4', 'groupId': 'OG001', 'lowerLimit': '198.48', 'upperLimit': '276.72'}, {'value': '192.0', 'groupId': 'OG002', 'lowerLimit': '162.22', 'upperLimit': '227.25'}, {'value': '197.7', 'groupId': 'OG003', 'lowerLimit': '167.69', 'upperLimit': '232.97'}, {'value': '209.5', 'groupId': 'OG004', 'lowerLimit': '174.89', 'upperLimit': '250.88'}, {'value': '204.4', 'groupId': 'OG005', 'lowerLimit': '172.26', 'upperLimit': '242.52'}, {'value': '211.6', 'groupId': 'OG006', 'lowerLimit': '182.90', 'upperLimit': '244.86'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29', 'description': 'Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) Set included all randomly assigned participants who received study vaccination, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least the Day 29 post-injection assessment, had no RT-PCR-confirmed influenza infection prior to Day 29 visit and had no major protocol deviations that impacted the immune response. Participants were analyzed according to the group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '88', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'OG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'OG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'OG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'OG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'OG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'OG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'classes': [{'title': 'Influenza A H1N1 Antibody', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.44', 'upperLimit': '3.67'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '4.68'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.86', 'upperLimit': '4.16'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '2.26', 'upperLimit': '3.19'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '2.55', 'upperLimit': '3.96'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '2.59', 'upperLimit': '3.82'}, {'value': '2.9', 'groupId': 'OG006', 'lowerLimit': '2.37', 'upperLimit': '3.44'}]}]}, {'title': 'Influenza A H3N2 (Darwin) Antibody', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.32', 'upperLimit': '3.46'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.35'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.77', 'upperLimit': '2.31'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '2.64', 'upperLimit': '3.71'}, {'value': '3.4', 'groupId': 'OG004', 'lowerLimit': '2.74', 'upperLimit': '4.13'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '2.88', 'upperLimit': '4.08'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.23', 'upperLimit': '3.14'}]}]}, {'title': 'Influenza A H3N2 (Newcastle) Antibody', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '2.78'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.24', 'upperLimit': '4.87'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '2.05', 'upperLimit': '2.92'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '2.66', 'upperLimit': '3.86'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '3.35', 'upperLimit': '5.24'}, {'value': '4.4', 'groupId': 'OG005', 'lowerLimit': '3.58', 'upperLimit': '5.53'}, {'value': '3.7', 'groupId': 'OG006', 'lowerLimit': '3.00', 'upperLimit': '4.59'}]}]}, {'title': 'Influenza A H3N2 (Hong Kong) Antibody', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.13', 'upperLimit': '3.31'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.50', 'upperLimit': '3.54'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.87', 'upperLimit': '4.08'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '2.56', 'upperLimit': '3.72'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '3.23', 'upperLimit': '4.84'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '4.10', 'upperLimit': '6.14'}, {'value': '4.1', 'groupId': 'OG006', 'lowerLimit': '3.26', 'upperLimit': '5.07'}]}]}, {'title': 'Influenza B/Yamagata Lineage', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.80'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.62', 'upperLimit': '2.15'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.52', 'upperLimit': '1.81'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '1.86'}, {'value': '1.2', 'groupId': 'OG004', 'lowerLimit': '1.07', 'upperLimit': '1.28'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '1.04', 'upperLimit': '1.21'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '0.99', 'upperLimit': '1.13'}]}]}, {'title': 'Influenza B/Victoria Lineage', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '1.81'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '2.06'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.30', 'upperLimit': '1.59'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '1.44', 'upperLimit': '1.78'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '1.56', 'upperLimit': '2.13'}, {'value': '1.7', 'groupId': 'OG005', 'lowerLimit': '1.45', 'upperLimit': '1.88'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '1.34', 'upperLimit': '1.72'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (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 randomly assigned participants who received study vaccination, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least the Day 29 post-injection assessment, had no RT-PCR-confirmed influenza infection prior to Day 29 visit and had no major protocol deviations that impacted the immune response. Participants were analyzed according to the group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}, {'value': '88', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'OG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'OG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'OG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'OG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'OG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'OG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'classes': [{'title': 'Influenza A H1N1 Antibody', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '26.81', 'upperLimit': '47.19'}, {'value': '49.4', 'groupId': 'OG001', 'lowerLimit': '38.67', 'upperLimit': '60.25'}, {'value': '44.2', 'groupId': 'OG002', 'lowerLimit': '34.02', 'upperLimit': '54.77'}, {'value': '40.2', 'groupId': 'OG003', 'lowerLimit': '29.85', 'upperLimit': '51.29'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '29.81', 'upperLimit': '50.87'}, {'value': '35.9', 'groupId': 'OG005', 'lowerLimit': '26.13', 'upperLimit': '46.54'}, {'value': '35.2', 'groupId': 'OG006', 'lowerLimit': '25.34', 'upperLimit': '46.14'}]}]}, {'title': 'Influenza A H3N2 (Darwin) Antibody', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '30.77', 'upperLimit': '51.54'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '13.37', 'upperLimit': '31.31'}, {'value': '21.1', 'groupId': 'OG002', 'lowerLimit': '13.36', 'upperLimit': '30.62'}, {'value': '40.2', 'groupId': 'OG003', 'lowerLimit': '29.85', 'upperLimit': '51.29'}, {'value': '37.8', 'groupId': 'OG004', 'lowerLimit': '27.77', 'upperLimit': '48.62'}, {'value': '45.7', 'groupId': 'OG005', 'lowerLimit': '35.22', 'upperLimit': '56.37'}, {'value': '33.0', 'groupId': 'OG006', 'lowerLimit': '23.30', 'upperLimit': '43.79'}]}]}, {'title': 'Influenza A H3N2 (Newcastle) Antibody', 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '16.37', 'upperLimit': '34.76'}, {'value': '53.9', 'groupId': 'OG001', 'lowerLimit': '43.04', 'upperLimit': '64.56'}, {'value': '32.6', 'groupId': 'OG002', 'lowerLimit': '23.36', 'upperLimit': '43.02'}, {'value': '47.1', 'groupId': 'OG003', 'lowerLimit': '36.33', 'upperLimit': '58.13'}, {'value': '52.2', 'groupId': 'OG004', 'lowerLimit': '41.43', 'upperLimit': '62.87'}, {'value': '55.4', 'groupId': 'OG005', 'lowerLimit': '44.70', 'upperLimit': '65.81'}, {'value': '48.9', 'groupId': 'OG006', 'lowerLimit': '38.05', 'upperLimit': '59.75'}]}]}, {'title': 'Influenza A H3N2 (Hong Kong) Antibody', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000', 'lowerLimit': '24.86', 'upperLimit': '44.98'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '29.13', 'upperLimit': '50.25'}, {'value': '47.4', 'groupId': 'OG002', 'lowerLimit': '37.03', 'upperLimit': '57.88'}, {'value': '44.8', 'groupId': 'OG003', 'lowerLimit': '34.15', 'upperLimit': '55.87'}, {'value': '53.3', 'groupId': 'OG004', 'lowerLimit': '42.51', 'upperLimit': '63.93'}, {'value': '57.6', 'groupId': 'OG005', 'lowerLimit': '46.86', 'upperLimit': '67.85'}, {'value': '52.3', 'groupId': 'OG006', 'lowerLimit': '41.35', 'upperLimit': '63.04'}]}]}, {'title': 'Influenza B/Yamagata Lineage', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '6.85', 'upperLimit': '21.45'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '9.75', 'upperLimit': '26.27'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '3.71', 'upperLimit': '15.92'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '4.84', 'upperLimit': '18.73'}, {'value': '1.1', 'groupId': 'OG004', 'lowerLimit': '0.03', 'upperLimit': '6.04'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.03', 'upperLimit': '5.91'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '4.11'}]}]}, {'title': 'Influenza B/ Victoria Lineage', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '5.28', 'upperLimit': '18.89'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '14.30', 'upperLimit': '32.55'}, {'value': '6.3', 'groupId': 'OG002', 'lowerLimit': '2.35', 'upperLimit': '13.24'}, {'value': '9.2', 'groupId': 'OG003', 'lowerLimit': '4.05', 'upperLimit': '17.32'}, {'value': '14.4', 'groupId': 'OG004', 'lowerLimit': '7.92', 'upperLimit': '23.43'}, {'value': '14.1', 'groupId': 'OG005', 'lowerLimit': '7.74', 'upperLimit': '22.95'}, {'value': '11.4', 'groupId': 'OG006', 'lowerLimit': '5.59', 'upperLimit': '19.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.\n\nSeroconversion was defined as a postbaseline titer ≥1:40 if baseline is \\<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP Set included all randomly assigned participants who received study vaccination, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least the Day 29 post-injection assessment, had no RT-PCR-confirmed influenza infection prior to Day 29 visit and had no major protocol deviations that impacted the immune response. Participants were analyzed according to the group to which they were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single intramuscular (IM) injection of mRNA-1010 50 micrograms (μg) on Day 1.'}, {'id': 'FG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'FG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'FG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'FG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'FG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'FG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '98'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '100'}, {'groupId': 'FG006', 'numSubjects': '101'}]}, {'type': 'Received Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '100'}, {'groupId': 'FG006', 'numSubjects': '100'}]}, {'type': 'Safety Set', 'comment': 'All randomly assigned participants who received the study vaccination.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '100'}, {'groupId': 'FG006', 'numSubjects': '98'}]}, {'type': 'Solicited Safety Set', 'comment': 'All randomly assigned participants who received the study vaccination and contributed any solicited AR data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '98'}, {'groupId': 'FG004', 'numSubjects': '100'}, {'groupId': 'FG005', 'numSubjects': '100'}, {'groupId': 'FG006', 'numSubjects': '97'}]}, {'type': 'Participants Were Randomized to mRNA-1012.1 62.5 μg But Received mRNA-1012.1 50 μg Instead', 'comment': 'These 2 participants were included in mRNA-1012.1 50 μg group for Safety Set and Solicited Safety Set.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'comment': '2 Participants randomized to receive mRNA-1012.1 62.5 μg but actually received mRNA-1012.1 50 μg.', 'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '96'}, {'groupId': 'FG004', 'numSubjects': '94'}, {'groupId': 'FG005', 'numSubjects': '96'}, {'groupId': 'FG006', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Other Than Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}, {'value': '100', 'groupId': 'BG006'}, {'value': '695', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'mRNA-1010 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010 50 μg on Day 1.'}, {'id': 'BG001', 'title': 'mRNA-1010.2 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.2 50 μg on Day 1.'}, {'id': 'BG002', 'title': 'mRNA-1010.3 50 μg', 'description': 'Participants received a single IM injection of mRNA-1010.3 50 μg on Day 1.'}, {'id': 'BG003', 'title': 'mRNA-1011.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1011.1 50 μg on Day 1.'}, {'id': 'BG004', 'title': 'mRNA-1011.2 40 μg', 'description': 'Participants received a single IM injection of mRNA-1011.2 40 μg on Day 1.'}, {'id': 'BG005', 'title': 'mRNA-1012.1 50 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 50 μg on Day 1.'}, {'id': 'BG006', 'title': 'mRNA-1012.1 62.5 μg', 'description': 'Participants received a single IM injection of mRNA-1012.1 62.5 μg on Day 1.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '7.17', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '6.95', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '7.47', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '6.17', 'groupId': 'BG003'}, {'value': '61.6', 'spread': '7.18', 'groupId': 'BG004'}, {'value': '60.7', 'spread': '7.79', 'groupId': 'BG005'}, {'value': '61.1', 'spread': '6.70', 'groupId': 'BG006'}, {'value': '61.2', 'spread': '7.07', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '381', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}, {'value': '314', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '138', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}, {'value': '81', 'groupId': 'BG006'}, {'value': '542', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '122', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}, {'value': '552', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) included all randomly assigned participants who received the study vaccination.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-03', 'size': 1347173, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-14T21:35', 'hasProtocol': True}, {'date': '2023-04-27', 'size': 1173966, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-14T21:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 698}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-04-12', 'resultsFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-28', 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)', 'timeFrame': '7 days post-vaccination', 'description': 'Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity.'}, {'measure': 'Number of Participants With Unsolicited AEs', 'timeFrame': 'Up to 28 days post-vaccination', '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. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.'}, {'measure': 'Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation', 'timeFrame': 'Day 1 to Day 181 (end of study [EOS])', 'description': '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/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up) and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains', 'timeFrame': 'Day 29', 'description': 'Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains', 'timeFrame': 'Baseline, Day 29', 'description': 'The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (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 Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains', 'timeFrame': 'Day 29', 'description': 'Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.\n\nSeroconversion was defined as a postbaseline titer ≥1:40 if baseline is \\<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza vaccine', 'mRNA-1010', 'mRNA-1011.1', 'mRNA-1011.2', 'mRNA-1012.1', 'Moderna'], 'conditions': ['Seasonal Influenza']}, 'referencesModule': {'references': [{'pmid': '39245055', 'type': 'DERIVED', 'citation': 'Hsu D, Jayaraman A, Pucci A, Joshi R, Mancini K, Chen HL, Koslovsky K, Mao X, Choi A, Henry C, Vakil J, Stadlbauer D, Jorquera P, Arunkumar GA, Sanchez-Crespo NE, Wadsworth LT, Bhupathy V, Du E, Avanesov A, Ananworanich J, Nachbagauer R. Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50-75 years: a phase 1/2, open-label, randomised trial. Lancet Infect Dis. 2025 Jan;25(1):25-35. doi: 10.1016/S1473-3099(24)00493-6. Epub 2024 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body mass index of 18 kilograms (kg)/square meter (m\\^2) to 35 kg/m\\^2 (inclusive) at the Screening Visit.\n* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration, and not currently breastfeeding.\n\nKey Exclusion Criteria:\n\n* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \\[°C\\]/100.4 degrees Fahrenheit \\[°F\\]) 72 hours prior to or at the Screening Visit or Day 1.\n* Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.\n* Participant has received systemic immunosuppressants for \\>14 days in total within 180 days prior to the Randomization Visit (for glucocorticosteroids ≥10 milligrams \\[mg\\]/day of prednisone equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.\n* Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.\n* Participant has received a seasonal influenza vaccine or any other influenza vaccine within 180 days prior to the Randomization Visit.\n* Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Randomization Visit.\n* Participant has had close contact to someone with or been diagnosed themselves with respiratory syncytial virus or SARS-CoV-2 infection as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to the Randomization Visit.\n* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study.\n\nNote: Other inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05827068', 'briefTitle': 'A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age', 'orgStudyIdInfo': {'id': 'mRNA-1011-P101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1011.1', 'description': 'Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.', 'interventionNames': ['Biological: mRNA-1011.1']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1011.2', 'description': 'Participants will receive mRNA-1011.2 by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1011.2']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1012.1 Dose Level A', 'description': 'Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1012.1']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1012.1 Dose Level B', 'description': 'Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1012.1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mRNA-1010', 'description': 'Participants will receive mRNA-1010 by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1010']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mRNA-1010.2', 'description': 'Participants will receive mRNA-1010.2 by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1010.2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mRNA-1010.3', 'description': 'Participants will receive mRNA-1010.3 by IM injection on Day 1.', 'interventionNames': ['Biological: mRNA-1010.3']}], 'interventions': [{'name': 'mRNA-1011.1', 'type': 'BIOLOGICAL', 'otherNames': ['Seasonal influenza vaccine'], 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1011.1']}, {'name': 'mRNA-1011.2', 'type': 'BIOLOGICAL', 'otherNames': ['Seasonal influenza vaccine'], 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1011.2']}, {'name': 'mRNA-1012.1', 'type': 'BIOLOGICAL', 'otherNames': ['Seasonal influenza vaccine'], 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1012.1 Dose Level A', 'mRNA-1012.1 Dose Level B']}, {'name': 'mRNA-1010', 'type': 'BIOLOGICAL', 'otherNames': ['Seasonal influenza vaccine'], 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1010']}, {'name': 'mRNA-1010.2', 'type': 'BIOLOGICAL', 'otherNames': ['Seasonal influenza vaccine'], 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1010.2']}, {'name': 'mRNA-1010.3', 'type': 'BIOLOGICAL', 'otherNames': ['Seasonal influenza vaccine'], 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1010.3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90805', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Research Institute', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Clinical Trials', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Tekton Research', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Critical Care, Pulmonary and Sleep Associates / CCT Research', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'CenExel RCA', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Associates, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'CenExel FCR', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30092', 'city': 'Norcross', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Clinic / CCT Research', 'geoPoint': {'lat': 33.94121, 'lon': -84.21353}}, {'zip': '20877', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'CenExel CBH', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'DelRicht Research', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '65807', 'city': 'Springfield', 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States', 'facility': 'Springville Dermatology / CCT Research', 'geoPoint': {'lat': 40.16523, 'lon': -111.61075}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}