Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-28 @ 8:25 PM
Study NCT ID:
NCT04649151
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Guatemala', 'Kenya', 'Mexico', 'South Africa'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'WeCareClinicalTrials@modernatx.com', 'phone': '+1-866-663-3762', 'title': 'Moderna WeCare Team', 'organization': 'ModernaTX, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Part 1C-2 enrollment discontinued before planned number of participants. Part 2 discontinued early due to availability of updated variant vaccine (mRNA-1273.222); no hypothesis testing done for primary endpoint/other endpoints not assessed.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Day 751', 'description': 'All-cause mortality: enrolled; AEs: participants received at least 1 dose of study drug.\n\nNon-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as unsolicited AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).', 'otherNumAtRisk': 2486, 'deathsNumAtRisk': 2486, 'otherNumAffected': 943, 'seriousNumAtRisk': 2486, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo by IM injection (Day 1 and Day 29).', 'otherNumAtRisk': 1240, 'deathsNumAtRisk': 1240, 'otherNumAffected': 155, 'seriousNumAtRisk': 1240, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Part 1B: mRNA-1273 100 µg', 'description': 'Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 22, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.', 'otherNumAtRisk': 1408, 'deathsNumAtRisk': 1408, 'otherNumAffected': 429, 'seriousNumAtRisk': 1408, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 28, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 12, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2: mRNA-1273 50 ug BD', 'description': 'Participants received open-label mRNA-1273 50 µg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 7, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 3: mRNA1273.222 50 µg 1 Dose', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1).', 'otherNumAtRisk': 388, 'deathsNumAtRisk': 388, 'otherNumAffected': 77, 'seriousNumAtRisk': 388, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG008', 'title': 'Part 3: mRNA-1273.222 50 ug Second Dose', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).', 'otherNumAtRisk': 335, 'deathsNumAtRisk': 335, 'otherNumAffected': 51, 'seriousNumAtRisk': 335, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 146, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 64, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 383, 'numAffected': 382}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 267, 'numAffected': 257}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 82, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mechanical urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Attention deficit hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 60, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 129, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 57, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 293, 'numAffected': 257}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 101, 'numAffected': 81}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Parapsoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Pectus excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syringomyelia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arnold-Chiari malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperbilirubinaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, 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'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Drug-induced liver injury', 'notes': 'Investigator and Sponsor assessment of drug-induced liver injury was not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaphylactic reaction', 'notes': 'Investigator and Sponsor assessment of anaphylactic reaction was not related to study drug due to long time to onset (171 days).', 'stats': 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gun shot wound', 'notes': 'AE of gunshot wound resulted in death. 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{'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 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0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Splenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vulvovaginal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vaginal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypercoagulation', 'notes': 'Sponsor assessment of AE of hypercoagulation was not related to study drug based on medical history, results of the heart biopsy, including findings of long-standing pre-existing heart failure and long time to onset (256 days).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiogenic shock', 'notes': 'Sponsor assessment of AE of cardiogenic shock was not related to study drug based on medical history, results of the heart biopsy, including findings of long-standing pre-existing heart failure and long time to onset (256 days).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2486, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2485', 'groupId': 'OG000'}, {'value': '1240', 'groupId': 'OG001'}, {'value': '1351', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '387', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}, {'id': 'OG002', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.'}, {'id': 'OG003', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}, {'id': 'OG004', 'title': 'Part 2: mRNA-1273 50 μg First Injection', 'description': 'Participants received 1 dose of 50 μg mRNA-1273 by IM injection (Day 1).'}, {'id': 'OG005', 'title': 'Part 2: mRNA-1273 50 μg Second Injection', 'description': 'Participants received 2nd dose of 50 μg mRNA-1273 by IM injection (Day 29).'}, {'id': 'OG006', 'title': 'Part 2: mRNA-1273 50 μg BD', 'description': 'Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.'}, {'id': 'OG007', 'title': 'Part 3: mRNA-1273.222 50 μg 1 Dose', 'description': 'Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '586', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}, {'value': '627', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '145', 'groupId': 'OG007'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '1250', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '62', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '627', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Any Solicited (Grade 1-4)', 'categories': [{'measurements': [{'value': '2466', 'groupId': 'OG000'}, {'value': '938', 'groupId': 'OG001'}, {'value': '1278', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '233', 'groupId': 'OG007'}]}]}], '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. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicated lower severity, and higher score indicated greater severity. Investigator reviewed if the solicited AR was recorded as an adverse event (AE) as detailed in the AE section. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited Safety Set included participants who received at least 1 dose of study drug and contributed any solicited AR data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2486', 'groupId': 'OG000'}, {'value': '1240', 'groupId': 'OG001'}, {'value': '1405', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '388', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}, {'id': 'OG002', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.'}, {'id': 'OG003', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}, {'id': 'OG004', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG005', 'title': 'Part 2: mRNA-1273 50 μg BD', 'description': 'Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.'}, {'id': 'OG006', 'title': 'Part 3: mRNA-1273.222 50 μg 1 Dose', 'description': 'Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '582', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days post-vaccination', 'description': 'An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). 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 or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE.\n\nNon-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part1/2 but were considered clinical events for efficacy in Part 3 and not AEs.\n\nA Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Set: participants who received at least 1 dose of study drug. As prespecified in the protocol, Part 1B was not assessed for this outcome measure. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'PRIMARY', 'title': 'Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '1401.670', 'groupId': 'OG000', 'lowerLimit': '1276.218', 'upperLimit': '1539.453'}, {'value': '1299.855', 'groupId': 'OG001', 'lowerLimit': '1175.380', 'upperLimit': '1437.511'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.078', 'ciLowerLimit': '0.940', 'ciUpperLimit': '1.237', 'estimateComment': 'GMR of P203 vs P301', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority of Geometric Mean value (based on geometric least squares means \\[GLSM\\]) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \\>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 57 Study P203/Day 57 Study P301', 'description': 'Pseudovirus nAb ID50 titers were measured using pseudovirus neutralization assay (PsVNA) assay. Antibody values reported as below the 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 if actual values were not available (LLOQ: 18.5 arbitrary units (AU)/milliliter (mL), ULOQ: 45118 AU/mL). Antibody levels were analyzed using an analysis of covariance (ANCOVA) model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1A PPIS: randomized participants who were selected for the Immunogenicity Subset, received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. Participants who were seropositive at baseline were excluded from the PPIS. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'PRIMARY', 'title': 'Part 1A Seroresponse Rate (SRR) for Serum Pseudovirus nAb ID50 in Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.7'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '99.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.9', 'estimateComment': 'SRR difference of P203 vs P301', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \\>-10%. and a point estimator \\>-5% (minimum threshold)'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 57 Study P203/Day 57 Study P301', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb ID50 measured using PsVNA assay are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4\\*LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ (LLOQ: 18.5 AU/mL), ULOQ: 45118 AU/mL).\n\nPPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1A PPIS: randomized participants who were selected for the Immunogenicity Subset, received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. Participants who were seropositive at baseline were excluded from the PPIS. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'PRIMARY', 'title': 'Part 1C-1 Geometric Mean Concentration (GMC) of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '7102.0', 'groupId': 'OG000', 'lowerLimit': '6553.2', 'upperLimit': '7696.8'}, {'value': '1400.4', 'groupId': 'OG001', 'lowerLimit': '1272.7', 'upperLimit': '1541.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.071', 'ciLowerLimit': '4.477', 'ciUpperLimit': '5.745', 'estimateComment': 'GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of the 95% CI of noninferiority margin of 1.5. GMR point estimate \\>=0.8 (minimum threshold).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'BD Day 29 Study P203/Day 57 Study P301', 'description': 'Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10, ULOQ: 281600). PPIS P301: randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.', 'unitOfMeasure': 'arbitrary units (AU)/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1C-1 PPIS-Neg: participants were baseline (pre-dose 1 of part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, received BD, and were pre-booster SARS-CoV2 negative. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'PRIMARY', 'title': 'Part 1C-1 SRR of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '99.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'SRR Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '2.4', 'estimateComment': 'SRR difference of P203 BD-Day 29 vs P301 Day 57', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \\>-10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'BD Day 29 Study P203/Day 57 Study P301', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) 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-rise if baseline was equal to or above LLOQ (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1C-1 PPIS-Neg: participants were baseline (pre-dose 1 of part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, received BD, and were pre-booster SARS-CoV2 negative. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'PRIMARY', 'title': 'Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '2727.8', 'groupId': 'OG000', 'lowerLimit': '2558.7', 'upperLimit': '2908.1'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '52.7', 'upperLimit': '60.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.191', 'ciLowerLimit': '43.765', 'ciUpperLimit': '53.065', 'estimateComment': 'GMR of P203 vs P301', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The superiority of GMC (based on GLSM\\] was considered demonstrated if: The lower bound of the 95% CI of the GMR was \\>1'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 Study P203/Day 57 Study P301', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 103 AU/mL, ULOQ: 28571 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint."}, {'type': 'PRIMARY', 'title': 'Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '9433.4', 'spread': '8496.8', 'groupId': 'OG000', 'lowerLimit': '8496.8', 'upperLimit': '10473.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'BD Day 29', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1C-2 PPIS: all randomized participants who received BD in Part 1C-2, had BD-Day 29 Ab assessment, had no major protocol deviations that impacted key or critical data, and did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'PRIMARY', 'title': 'Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}], 'classes': [{'categories': [{'measurements': [{'value': '7351.5', 'spread': '5621.7', 'groupId': 'OG000', 'lowerLimit': '5621.7', 'upperLimit': '9613.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 57', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2 PPIS: all randomized participants who received at least 1 dose of the planned study drug, had Ab assessment for the analysis endpoint, and had no major protocol deviations that could impact key or critical data.'}, {'type': 'PRIMARY', 'title': 'Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against SARS-CoV-2 Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '7603.9', 'groupId': 'OG000', 'lowerLimit': '7004.6', 'upperLimit': '8254.6'}, {'value': '1692.3', 'groupId': 'OG001', 'lowerLimit': '1543.4', 'upperLimit': '1855.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.493', 'ciLowerLimit': '3.972', 'ciUpperLimit': '5.083', 'estimateComment': 'GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority of Geometric Mean value (based on GLSM) was considered demonstrated if: The lower bound of the 95% CI of the GMR was \\>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 Study P203/Day 57 Study P301', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint."}, {'type': 'PRIMARY', 'title': 'Part 2 SRR of Pseudovirus nAb Against Ancestral Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}], 'classes': [{'categories': [{'measurements': [{'value': '91.3', 'spread': '79.2', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '97.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 57', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) 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-rise if baseline was equal to or above the LLOQ (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2 PPIS: all randomized participants who received at least 1 dose of the planned study drug, had Ab assessment for the analysis endpoint, and had no major protocol deviations that could impact key or critical data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2486', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '1408', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '388', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1B: mRNA-1273 100 μg', 'description': 'Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273.'}, {'id': 'OG002', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.'}, {'id': 'OG003', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}, {'id': 'OG004', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG005', 'title': 'Part 2: mRNA-1273 50 μg BD', 'description': 'Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.'}, {'id': 'OG006', 'title': 'Part 3: mRNA-1273.222 50 μg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 μg at approximately 6 months after the first dose (Day 181).'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'MAAEs', 'categories': [{'measurements': [{'value': '1040', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '541', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '183', 'groupId': 'OG006'}]}]}, {'title': 'AEs Leading to Study 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': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 751', 'description': '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 were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, 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\\]). Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were defined as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who received at least 1 dose of mRNA-1273 were included in the analysis. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Note: Part 3 is presented for overall study for this assessment (AE section presents AEs separately for 1 dose and second dose)."}, {'type': 'SECONDARY', 'title': 'Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2142', 'groupId': 'OG000'}, {'value': '1044', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.3', 'ciLowerLimit': '26.6', 'ciUpperLimit': '78.6', 'statisticalMethod': 'VE', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Vaccine efficacy (VE, percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).', 'nonInferiorityComment': 'The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection', 'description': 'SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 status at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive postbaseline; or positive postbaseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data.'}, {'type': 'SECONDARY', 'title': 'Part 1A Number of Participants With Asymptomatic SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2142', 'groupId': 'OG000'}, {'value': '1044', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.5', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '72.2', 'statisticalMethod': 'VE', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).', 'nonInferiorityComment': 'The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection', 'description': 'Asymptomatic SARS-CoV-2 infection was defined as absence of symptoms and a positive RT-PCR or serology test (bAb levels against SARS-CoV-2 nucleocapsid protein) post dosing in participants who did not have an infection at baseline or pre-Dose 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data.'}, {'type': 'SECONDARY', 'title': 'Part 1A Number of Participants With a First Occurrence of Symptomatic COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2142', 'groupId': 'OG000'}, {'value': '1044', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.0', 'ciLowerLimit': '61.2', 'estimateComment': 'The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.', 'statisticalMethod': 'VE', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).', 'ciUpperLimitComment': 'NA = not estimable (not reached).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 43 (14 days after second injection) up to 2.5 months after second injection', 'description': 'COVID-19 was defined as symptomatic disease based on the following criteria: participants experienced at least 2 of the following systemic symptoms: fever (≥ 38ºC/≥ 100.4ºF), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and had at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data.'}, {'type': 'SECONDARY', 'title': 'Part 1A Number of Participants With Secondary Case Definition of COVID-19 (Center for Disease Control and Prevention [CDC] Case Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2142', 'groupId': 'OG000'}, {'value': '1044', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '89.9', 'ciLowerLimit': '51.0', 'ciUpperLimit': '98.9', 'statisticalMethod': 'VE', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).', 'nonInferiorityComment': 'The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection', 'description': 'Secondary case definition of COVID-19 was defined by the following criteria: 1 systemic or respiratory symptoms: fever (temperature \\> 38ºC/≥ 100.4ºF), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, or vomiting or diarrhea, and at least one positive test for SARS-CoV-2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1A PP Set for Efficacy: all randomized participants who received planned doses of study drug, had no immunologic or virologic evidence of prior COVID-19, and had no major protocol deviations that impact key or critical efficacy data.'}, {'type': 'SECONDARY', 'title': 'Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.'}], 'classes': [{'title': 'B.1.1.7', 'categories': [{'measurements': [{'value': '100.0', 'spread': '98.9', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}, {'title': 'B.1.351', 'categories': [{'measurements': [{'value': '100.0', 'spread': '98.9', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}, {'title': 'B.1.617.2', 'categories': [{'measurements': [{'value': '100.0', 'spread': '98.9', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}, {'title': 'P.1', 'categories': [{'measurements': [{'value': '100.0', 'spread': '98.9', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BD Day 29', 'description': 'Percentage of participants with seroresponse for bAb measured using (MesoScale Discovery) MSD are reported. Seroresponse from baseline (pre-Dose 1) 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-rise if baseline (pre-Dose 1) is equal to or above the LLOQ.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'Part 1C-1 GMC of Post-booster Pseudovirus nAb Against Variant Strain (B.1.1.529)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.'}], 'classes': [{'categories': [{'measurements': [{'value': '943.4', 'spread': '853.5', 'groupId': 'OG000', 'lowerLimit': '853.5', 'upperLimit': '1042.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'BD Day 29', 'description': 'Post-booster Pseudovirus nAb against B.1.1.529 (LLOQ: 8 AU/mL, ULOQ: 24503 AU/mL). Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available.', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'Part 3 SRR of Serum Pseudovirus nAb Post Dose 1 of mRNA-1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29 Study P203/Day 57 Study P301', 'description': 'Seroresponse from pre Dose 1 Baseline 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 rise if Baseline was equal to or above the LLOQ (LLOQ: 103 AU/mL, ULOQ:\n\n28571 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 3 PPIS-Pos: participants received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, SARS-CoV-2 positive at Baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint."}, {'type': 'SECONDARY', 'title': 'Part 3 Pseudovirus nAb SRR of Post Dose 1 of mRNA-1273.222 Against Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).'}, {'id': 'OG001', 'title': 'Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}], 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '96.9'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29 P203/Day 57 P301', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse from pre Dose 1 Baseline 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 rise if Baseline was equal to or above the LLOQ. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 3 PPIS-Pos: participants who received Dose 1 of mRNA-1273.222, had Day 29 antibody assessments, no major protocol deviations, did not receive off-study COVID-19 vaccination prior to Day 29, and were SARS-CoV-2 positive at baseline. 'Overall number of participants analyzed' = participants evaluable for the endpoint."}, {'type': 'SECONDARY', 'title': 'Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).'}], 'classes': [{'title': 'BA.5', 'categories': [{'measurements': [{'value': '282734.2', 'groupId': 'OG000', 'lowerLimit': '266581.0', 'upperLimit': '299866.1'}]}]}, {'title': 'AY.4', 'categories': [{'measurements': [{'value': '557963.4', 'groupId': 'OG000', 'lowerLimit': '529270.6', 'upperLimit': '588211.6'}]}]}, {'title': 'B.1.1.7', 'categories': [{'measurements': [{'value': '434879.0', 'groupId': 'OG000', 'lowerLimit': '412699.2', 'upperLimit': '458250.8'}]}]}, {'title': 'B.1.351', 'categories': [{'measurements': [{'value': '431476.5', 'groupId': 'OG000', 'lowerLimit': '409656.1', 'upperLimit': '454459.1'}]}]}, {'title': 'B.1.1.529', 'categories': [{'measurements': [{'value': '189826.0', 'groupId': 'OG000', 'lowerLimit': '178578.0', 'upperLimit': '201782.5'}]}]}, {'title': 'P.1', 'categories': [{'measurements': [{'value': '471868.9', 'groupId': 'OG000', 'lowerLimit': '446431.3', 'upperLimit': '498756.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29', 'description': 'mRNA-1273.222 bAb was measured using a S-binding IgG immunoassay. Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 397 AU/ml, ULOQ: 2200000 AU/mL).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 3 PPIS: all participants who received Dose 1 of mRNA-1273.222 and had both Baseline (pre Dose 1) and Day 29 antibody assessment, had no major protocol deviations that impacted key or critical data; and had not received off-study COVID-19 vaccination prior to Day 29. 'Overall number of participants analyzed' = participants evaluable for the endpoint."}, {'type': 'SECONDARY', 'title': 'Part 1C-2 GM Value of mRNA-1273 Booster Against Variants of Interest at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}], 'timeFrame': 'Day 29', 'reportingStatus': 'POSTED', 'populationDescription': 'As a result of emergence of a more divergent variant of concern (Omicron), Part 1C-2 enrollment and booster dosing were discontinued. Therefore, data were collected for Part 1C-2 Primary Outcome Measure but after Part 1C-2 was discontinued, per Sponsor, it was decided that data would not be collected for this Part 1C-2 Secondary Outcome Measure and instead collect data for the more updated variant containing vaccine (Part 3: mRNA-1273.222).'}, {'type': 'SECONDARY', 'title': 'Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.848', 'groupId': 'OG000', 'lowerLimit': '60.348', 'upperLimit': '71.850'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '346830.736', 'groupId': 'OG000', 'lowerLimit': '330758.387', 'upperLimit': '363684.079'}]}]}, {'title': 'Day 209', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79624.290', 'groupId': 'OG000', 'lowerLimit': '73959.321', 'upperLimit': '85723.172'}]}]}, {'title': 'Day 394', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58647.246', 'groupId': 'OG000', 'lowerLimit': '52309.921', 'upperLimit': '65752.336'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 57, 209, 394', 'description': 'SARS-CoV-2 Spike Protein-specific bAb were measured using MSD electrochemiluminescence multiplex assay. Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 69 AU/mL, ULOQ: 14400000 AU/mL).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1A PPIS for long term analysis included all randomized participants who had a negative SARS-CoV-2 status at baseline (pre-Dose 1), received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.249', 'groupId': 'OG000', 'lowerLimit': '10.712', 'upperLimit': '11.812'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1868.363', 'groupId': 'OG000', 'lowerLimit': '1758.809', 'upperLimit': '1984.742'}]}]}, {'title': 'Day 209', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '625.363', 'groupId': 'OG000', 'lowerLimit': '583.319', 'upperLimit': '670.437'}]}]}, {'title': 'Day 394', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '550.262', 'groupId': 'OG000', 'lowerLimit': '489.875', 'upperLimit': '618.093'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 57, 209, 394', 'description': 'SARS-CoV-2-Specific nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1A PPIS for long term analysis included all randomized participants who had a negative SARS-CoV-2 status at baseline (pre-Dose 1), received planned doses of study drug per schedule, complied with immunogenicity testing schedule, and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint. 'Number analyzed' = participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1C-1.'}], 'classes': [{'title': 'B.1.1.7', 'categories': [{'measurements': [{'value': '581097.8', 'spread': '543987.7', 'groupId': 'OG000', 'lowerLimit': '543987.7', 'upperLimit': '620739.5'}]}]}, {'title': 'B.1.351', 'categories': [{'measurements': [{'value': '431569.2', 'spread': '404983.2', 'groupId': 'OG000', 'lowerLimit': '404983.2', 'upperLimit': '459900.6'}]}]}, {'title': 'B.1.617.2', 'categories': [{'measurements': [{'value': '456423.3', 'spread': '429083.9', 'groupId': 'OG000', 'lowerLimit': '429083.9', 'upperLimit': '485504.8'}]}]}, {'title': 'P.1', 'categories': [{'measurements': [{'value': '417277.2', 'spread': '391682.5', 'groupId': 'OG000', 'lowerLimit': '391682.5', 'upperLimit': '444544.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'BD Day 29', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. B.1.1.7 (LLOQ: 52, ULOQ: 8800000), B.1.351 (LLOQ: 111, ULOQ: 5000000), B.1.617.2 (LLOQ: 49, ULOQ: 7400000), P.1 (LLOQ: 143, ULOQ: 5800000).', 'unitOfMeasure': 'AU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1C-1 PPIS: participants were baseline (pre-dose 1 of Part 1A) SARS-CoV-2 negative, had BD-Day 1 and BD-Day 29 Ab assessment, had no major protocol deviations, did not receive off-study COVID-19 vaccination prior to BD-Day 29 visit, received 2 doses of mRNA-1273 in the Blinded Phase per schedule, and received BD. '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': '2486', 'groupId': 'OG000'}, {'value': '1240', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '1408', 'groupId': 'OG003'}, {'value': '155', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '388', 'groupId': 'OG007'}, {'value': '335', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 100 μg by IM injection (Day 1 and Day 29).'}, {'id': 'OG002', 'title': 'Part 1B: mRNA-1273 100 µg', 'description': 'Participants previously received 2 doses of placebo in the blinded phase and then received crossover vaccination with 100 μg of mRNA-1273.'}, {'id': 'OG003', 'title': 'Part 1C-1: mRNA-1273 50 µg BD', 'description': 'Participants received mRNA-1273 100 µg in blinded or cross-over phase (Parts 1A or 1B) and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 1 C-1.'}, {'id': 'OG004', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}, {'id': 'OG005', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'OG006', 'title': 'Part 2: mRNA-1273 50 μg BD', 'description': 'Participants received open-label mRNA-1273 50 μg in Part 2 and then a single BD of 50 μg mRNA-1273 IM injection on BD Day 1 in Part 2.'}, {'id': 'OG007', 'title': 'Part 3: mRNA-1273.222 50 μg 1 Dose', 'description': 'Participants received 1 dose of mRNA-1273.222 50 μg by IM injection (Day 1).'}, {'id': 'OG008', 'title': 'Part 3: mRNA-1273.222 50 ug Second Dose', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1) and a second dose approximately 6 months after the first dose (Day 181).'}], 'classes': [{'title': 'Deaths', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Deaths related to study drug', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 751', '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': 'Safety Set: participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants received at least 1 of 2 doses of 100 micrograms (μg) mRNA-1273 by intramuscular (IM) injection (Day 1 and Day 29).'}, {'id': 'FG001', 'title': 'Part 1A: Placebo', 'description': 'Participants received at least 1 of 2 doses of placebo matched to mRNA-1273 by IM injection (Day 1 and Day 29). Participants had the option to receive crossover vaccination with 100 μg mRNA-1273 in Part 1B.'}, {'id': 'FG002', 'title': 'Part 1C-2: mRNA-1273 50 μg Booster Dose (BD)', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under emergency use authorization (EUA), received a single BD of 50 μg mRNA-1273 IM injection on BD Day 1.'}, {'id': 'FG003', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'FG004', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Some participants may have received a second dose of mRNA-1273.222 50 µg at approximately 6 months after the first dose (Day 181).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2490'}, {'groupId': 'FG001', 'numSubjects': '1243'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '388'}]}, {'type': 'Part 1: 1st Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2486'}, {'groupId': 'FG001', 'numSubjects': '1240'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 1: 2nd Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2480'}, {'groupId': 'FG001', 'numSubjects': '1222'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 2: 1st Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 2: 2nd Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 3: 1 Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '388'}]}, {'type': 'Part 3: 2 Doses', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '335'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2486'}, {'groupId': 'FG001', 'numSubjects': '1240'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '388'}]}, {'type': 'Solicited Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2485'}, {'groupId': 'FG001', 'numSubjects': '1240'}, {'groupId': 'FG002', 'numSubjects': '125'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '387'}]}, {'type': 'PPIS', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '136'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '373'}]}, {'type': 'Per Protocol (PP) Set for Efficacy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2142'}, {'groupId': 'FG001', 'numSubjects': '1044'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 2 BD', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'PPIS SARS-CoV-2 Positive (PPIS-Pos)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '372'}]}, {'type': 'Part 1C-1 BD', 'achievements': [{'comment': 'Received vaccination with 100 μg mRNA-1273 in Part 1A prior to BD in Part 1C-1.', 'groupId': 'FG000', 'numSubjects': '1357'}, {'comment': 'Received crossover vaccination with 100 μg mRNA-1273 in Part 1B prior to BD in Part 1C-1.', 'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 1B Crossover Vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Received crossover vaccination with 100 μg mRNA-1273 in Part 1B after receiving placebo in Part 1A.', 'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Part 1C-1 PPIS-Negative (Neg)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1274'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '143'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '358'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1216'}, {'groupId': 'FG001', 'numSubjects': '1169'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received another COVID-19 vaccine under EUA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '495'}, {'groupId': 'FG001', 'numSubjects': '730'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '294'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study included Part 1A as the Blinded Phase with participants remaining blinded until the initiation of Part 1B (open-label cross-over vaccination phase), and Parts 1C-1, 1C-2, 2, and 3 as open-label.', 'preAssignmentDetails': 'A per-protocol immunogenicity subset (PPIS) of randomly selected participants from study mRNA-1273-P301 (P301) (NCT04470427) aged 18-25 meeting pre-specified criteria (N=296) was used for comparison assessments of immune response.\n\nStudy "Completed" and "Not Completed" data reported in the Participant Flow were collected from "Overall Study" (that is, as 1 period regardless if a booster dose was received).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2490', 'groupId': 'BG000'}, {'value': '1243', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}, {'value': '296', 'groupId': 'BG005'}, {'value': '4624', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1A: mRNA-1273 100 μg', 'description': 'Participants were randomized to receive 2 doses of 100 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'BG001', 'title': 'Part 1A: Placebo', 'description': 'Participants were randomized to receive 2 doses of placebo by IM injection (Day 1 and Day 29). Participants had the option to receive crossover vaccination with 100 μg mRNA-1273 in Part 1B.'}, {'id': 'BG002', 'title': 'Part 1C-2: mRNA-1273 50 μg BD', 'description': 'Participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA, received a single booster of 50 μg mRNA-1273 IM injection on BD Day 1.'}, {'id': 'BG003', 'title': 'Part 2: mRNA-1273 50 μg', 'description': 'Participants received at least 1 of 2 doses of 50 μg mRNA-1273 by IM injection (Day 1 and Day 29).'}, {'id': 'BG004', 'title': 'Part 3: mRNA-1273.222 50 µg', 'description': 'Participants received 1 dose of mRNA-1273.222 50 µg by IM injection (Day 1). Participants may have received a second dose of mRNA-1273.222 50 µg at approximately month 6 after the first dose (Day 181).'}, {'id': 'BG005', 'title': 'Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg', 'description': 'Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age Categorical Data for Participants Enrolled in Study mRNA-1273-P203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2490', 'groupId': 'BG000'}, {'value': '1243', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4328', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Adolescents (12-17 years)', 'measurements': [{'value': '2490', 'groupId': 'BG000'}, {'value': '1243', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4328', 'groupId': 'BG006'}]}, {'title': 'Adults (18-64 years)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Age Categorical Data for Participants Enrolled in Study mRNA-1273-P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '296', 'groupId': 'BG005'}, {'value': '296', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Adolescents (12-17 years)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Adults (18-64 years)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '296', 'groupId': 'BG005'}, {'value': '296', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Sex Data for Participants Enrolled in Study mRNA-1273-P203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2490', 'groupId': 'BG000'}, {'value': '1243', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4328', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1206', 'groupId': 'BG000'}, {'value': '607', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '185', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2102', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1284', 'groupId': 'BG000'}, {'value': '636', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '203', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2226', 'groupId': 'BG006'}]}]}, {'title': 'Sex Data for Participants Enrolled in Study mRNA-1273-P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '296', 'groupId': 'BG005'}, {'value': '296', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '153', 'groupId': 'BG005'}, {'value': '153', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '143', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Ethnicity Data for Participants Enrolled in Study mRNA-1273-P203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2490', 'groupId': 'BG000'}, {'value': '1243', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4328', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '367', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '850', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2190', 'groupId': 'BG000'}, {'value': '1079', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3442', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}, {'title': 'Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '296', 'groupId': 'BG005'}, {'value': '296', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}, {'value': '78', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '216', 'groupId': 'BG005'}, {'value': '216', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race Data for Participants Enrolled in Study mRNA-1273-P203', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2490', 'groupId': 'BG000'}, {'value': '1243', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4328', 'groupId': 'BG006'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '2087', 'groupId': 'BG000'}, {'value': '1043', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3314', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '229', 'groupId': 'BG006'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Multiple', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '180', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '259', 'groupId': 'BG006'}]}, {'title': 'Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'Race Data for Participants Enrolled in Study mRNA-1273-P301', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '296', 'groupId': 'BG005'}, {'value': '296', 'groupId': 'BG006'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '207', 'groupId': 'BG005'}, {'value': '207', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics data of participants enrolled in Study mRNA-1273-P301 have been reported separately.'}], 'populationDescription': 'Part 1A Randomization Set: All participants who were randomized. Parts 1C-2, 2, and 3 Safety Set: participants who received at least 1 dose of study drug in Study mRNA-1273-P203 (P203). Study mRNA-1273-P301 (P301) (NCT04470427) mRNA-1273 100 μg: PPIS of randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-19', 'size': 3096963, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-09T18:03', 'hasProtocol': True}, {'date': '2024-06-19', 'size': 25415921, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-09T18:04', 'hasProtocol': False}, {'date': '2023-12-21', 'size': 7810865, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-09T18:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Part 1A is observer-blind. Participants will remain blinded until the initiation of Part 1B.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2020-11-30', 'resultsFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Deaths Related to Study Drug', 'timeFrame': 'Day 1 up to Day 751', '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)', '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. Solicited ARs considered causally related to injection were graded 1-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicated lower severity, and higher score indicated greater severity. Investigator reviewed if the solicited AR was recorded as an adverse event (AE) as detailed in the AE section. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the AE section.'}, {'measure': 'Number of Participants With Unsolicited AEs', 'timeFrame': 'Up to 28 days post-vaccination', 'description': 'An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). 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 or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE.\n\nNon-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were classified as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part1/2 but were considered clinical events for efficacy in Part 3 and not AEs.\n\nA Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the AE section.'}, {'measure': 'Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'Day 57 Study P203/Day 57 Study P301', 'description': 'Pseudovirus nAb ID50 titers were measured using pseudovirus neutralization assay (PsVNA) assay. Antibody values reported as below the 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 if actual values were not available (LLOQ: 18.5 arbitrary units (AU)/milliliter (mL), ULOQ: 45118 AU/mL). Antibody levels were analyzed using an analysis of covariance (ANCOVA) model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.'}, {'measure': 'Part 1A Seroresponse Rate (SRR) for Serum Pseudovirus nAb ID50 in Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'Day 57 Study P203/Day 57 Study P301', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb ID50 measured using PsVNA assay are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4\\*LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ (LLOQ: 18.5 AU/mL), ULOQ: 45118 AU/mL).\n\nPPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria were used for comparison assessments of immune response.'}, {'measure': 'Part 1C-1 Geometric Mean Concentration (GMC) of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'BD Day 29 Study P203/Day 57 Study P301', 'description': 'Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10, ULOQ: 281600). PPIS P301: randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.'}, {'measure': 'Part 1C-1 SRR of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'BD Day 29 Study P203/Day 57 Study P301', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) 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-rise if baseline was equal to or above LLOQ (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.'}, {'measure': 'Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'Day 29 Study P203/Day 57 Study P301', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 103 AU/mL, ULOQ: 28571 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.'}, {'measure': 'Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29', 'timeFrame': 'BD Day 29', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).'}, {'measure': 'Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57', 'timeFrame': 'Day 57', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).'}, {'measure': 'Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against SARS-CoV-2 Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'Day 29 Study P203/Day 57 Study P301', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL). ANCOVA model with the group variable (adolescents in P203 and young adults in P301) as fixed effect. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.'}, {'measure': 'Part 2 SRR of Pseudovirus nAb Against Ancestral Strain', 'timeFrame': 'Day 57', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse relative to pre-Dose 1 (baseline) 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-rise if baseline was equal to or above the LLOQ (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).'}, {'measure': 'Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation', 'timeFrame': 'Day 1 up to Day 751', 'description': '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 were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, 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\\]). Non-serious SARs persisting beyond 7 days, leading to discontinuation, or medically attended were defined as AEs in Part 1/2 but not in Part 3. COVID-19/SARS-CoV-2 infections were AEs in Part 1/2 but were considered clinical events for efficacy in Part 3 and not AEs.'}], 'secondaryOutcomes': [{'measure': 'Part 1A Number of Participants With a SARS-CoV-2 Infection (Symptomatic or Asymptomatic)', 'timeFrame': 'Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection', 'description': 'SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 status at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive postbaseline; or positive postbaseline.'}, {'measure': 'Part 1A Number of Participants With Asymptomatic SARS-CoV-2 Infection', 'timeFrame': 'Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection', 'description': 'Asymptomatic SARS-CoV-2 infection was defined as absence of symptoms and a positive RT-PCR or serology test (bAb levels against SARS-CoV-2 nucleocapsid protein) post dosing in participants who did not have an infection at baseline or pre-Dose 1.'}, {'measure': 'Part 1A Number of Participants With a First Occurrence of Symptomatic COVID-19', 'timeFrame': 'Day 43 (14 days after second injection) up to 2.5 months after second injection', 'description': 'COVID-19 was defined as symptomatic disease based on the following criteria: participants experienced at least 2 of the following systemic symptoms: fever (≥ 38ºC/≥ 100.4ºF), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or experienced at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and had at least 1 nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS-CoV-2.'}, {'measure': 'Part 1A Number of Participants With Secondary Case Definition of COVID-19 (Center for Disease Control and Prevention [CDC] Case Definition)', 'timeFrame': 'Day 43 (14 days after second injection) up to a median follow up of 2.5 months after second injection', 'description': 'Secondary case definition of COVID-19 was defined by the following criteria: 1 systemic or respiratory symptoms: fever (temperature \\> 38ºC/≥ 100.4ºF), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches, or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, or vomiting or diarrhea, and at least one positive test for SARS-CoV-2.'}, {'measure': 'Part 1C-1 SRR of the Post-booster Serum Binding Antibody (bAb) Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD', 'timeFrame': 'BD Day 29', 'description': 'Percentage of participants with seroresponse for bAb measured using (MesoScale Discovery) MSD are reported. Seroresponse from baseline (pre-Dose 1) 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-rise if baseline (pre-Dose 1) is equal to or above the LLOQ.'}, {'measure': 'Part 1C-1 GMC of Post-booster Pseudovirus nAb Against Variant Strain (B.1.1.529)', 'timeFrame': 'BD Day 29', 'description': 'Post-booster Pseudovirus nAb against B.1.1.529 (LLOQ: 8 AU/mL, ULOQ: 24503 AU/mL). Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available.'}, {'measure': 'Part 3 SRR of Serum Pseudovirus nAb Post Dose 1 of mRNA-1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'Day 29 Study P203/Day 57 Study P301', 'description': 'Seroresponse from pre Dose 1 Baseline 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 rise if Baseline was equal to or above the LLOQ (LLOQ: 103 AU/mL, ULOQ:\n\n28571 AU/mL). PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison of immune response.'}, {'measure': 'Part 3 Pseudovirus nAb SRR of Post Dose 1 of mRNA-1273.222 Against Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301', 'timeFrame': 'Day 29 P203/Day 57 P301', 'description': 'Percentage of participants with seroresponse for pseudovirus nAb measured using PsVNA assay are reported. Seroresponse from pre Dose 1 Baseline 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 rise if Baseline was equal to or above the LLOQ. PPIS P301: randomly selected participants from Study P301 aged 18-25 meeting pre-specified criteria and SARS-CoV-2 negative were used for comparison assessments of immune response.'}, {'measure': 'Part 3 GM Value of Post Dose 1 (Day 29) of mRNA-1273.222 bAb Against Other Variants of Interest', 'timeFrame': 'Day 29', 'description': 'mRNA-1273.222 bAb was measured using a S-binding IgG immunoassay. Antibody values reported as below the LLOQ were replaced by 0.5 \\* LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 397 AU/ml, ULOQ: 2200000 AU/mL).'}, {'measure': 'Part 1C-2 GM Value of mRNA-1273 Booster Against Variants of Interest at Day 29', 'timeFrame': 'Day 29'}, {'measure': 'Part 1A GM Level of SARS-CoV-2 Spike Protein-specific bAb at Days 1, 57, 209, 394', 'timeFrame': 'Days 1, 57, 209, 394', 'description': 'SARS-CoV-2 Spike Protein-specific bAb were measured using MSD electrochemiluminescence multiplex assay. Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 69 AU/mL, ULOQ: 14400000 AU/mL).'}, {'measure': 'Part 1A GM Value of SARS-CoV-2-Specific nAb at Days 1, 57, 209, 394', 'timeFrame': 'Days 1, 57, 209, 394', 'description': 'SARS-CoV-2-Specific nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ are replaced by the ULOQ if actual values are not available (LLOQ: 10 AU/mL, ULOQ: 281600 AU/mL).'}, {'measure': 'Part 1C-1 GM Value of Post-booster Dose Serum bAb Against Variants of Interest (B.1.1.7, B.1.351, B.1.617.2, and P.1) as Measured by MSD', 'timeFrame': 'BD Day 29', 'description': 'Antibody values reported as below the LLOQ were replaced by 0.5\\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. B.1.1.7 (LLOQ: 52, ULOQ: 8800000), B.1.351 (LLOQ: 111, ULOQ: 5000000), B.1.617.2 (LLOQ: 49, ULOQ: 7400000), P.1 (LLOQ: 143, ULOQ: 5800000).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA-1273', 'mRNA-1273 vaccine', 'SARS-CoV-2', 'SARS-CoV-2 Vaccine', 'mRNA-1273.222 vaccine', 'SARS-CoV-2 VOC', 'SARS-CoV-2 VOC vaccine', 'Omicron', 'Variant', 'Coronavirus', 'Virus Diseases', 'Messenger RNA', 'COVID-19', 'COVID-19 Vaccine', 'Moderna'], 'conditions': ['SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '39332418', 'type': 'DERIVED', 'citation': 'Figueroa AL, Torres D, Reyes-Acuna C, Matherne P, Yeakey A, Deng W, Xu W, Sigal Y, Chambers G, Olsen M, Girard B, Miller JM, Das R, Priddy F. Safety and immunogenicity of a single-dose omicron-containing COVID-19 vaccination in adolescents: an open-label, single-arm, phase 2/3 trial. Lancet Infect Dis. 2025 Feb;25(2):208-217. doi: 10.1016/S1473-3099(24)00501-2. Epub 2024 Sep 24.'}, {'pmid': '34379915', 'type': 'DERIVED', 'citation': 'Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, Ding B, Dooley J, Girard B, Hillebrand W, Pajon R, Miller JM, Leav B, McPhee R. Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. N Engl J Med. 2021 Dec 9;385(24):2241-2251. doi: 10.1056/NEJMoa2109522. Epub 2021 Aug 11.'}], 'seeAlsoLinks': [{'url': 'http://TeenCoveStudy.com', 'label': 'Click here to access the website, http://TeenCoveStudy.com, for additional information for the study, such as Study Overview, Participation, Site Locations, along with contact numbers for each location for the study.'}]}, 'descriptionModule': {'briefSummary': 'The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.', 'detailedDescription': 'This is a Phase 2/3 study, with Part 1A (Blinded Phase), Part 1B (Open-label Observational Phase), Part 1C (Booster Dose \\[BD\\] Phase), which consists of Part 1C-1 and Part 1C-2, Part 2 (Open-Label), and Part 3 (Open-label). Participants in Part 1A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part 1B of the study is designed to offer participants whose age group becomes Emergency Use Authorization (EUA) eligible to be unblinded so that participants who received placebo in Part 1A can request 2 doses of open-label mRNA-1273 vaccine. Part 1C-1 of the study will offer participants in Part 1A and Part 1B who are at least 5 months from the last dose, the option to request a homologous BD of mRNA-1273. Part 1C-2 is designed to provide a heterologous BD of mRNA-1273 to eligible participants who completed primary COVID-19 vaccination series with a non-Moderna vaccine under EUA and are at least 3 months from the last dose. Part 2 is an open-label design. Participants will receive 2 doses and may receive a booster dose of mRNA-1273 SARS-CoV-2 vaccine. Part 3 is an open-label design. Participants will receive up to 2 doses of mRNA-1273.222 vaccine.\n\nPlease access http://TeenCoveStudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor Part 1A, Part 2 and Part 3:\n\n* Participants 12 to \\<18 years of age at the time of consent (Screening Visit, Day 0) who, in the opinion of the Investigator, are in good general health based on review of medical history and screening physical examination.\n* Investigator assessment that the participant, in the case of an emancipated minor, or parent(s)/legally acceptable representative(s) (LAR\\[s\\]) understand and is willing and physically able to comply with protocol-mandated follow up, including all procedures and provides written informed consent/assent.\n* Body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit (Day 0)\n* Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy).\n* Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test at Screening (Day 0), on the day of the first injection (Day 1), on the day of the second injection (Day 29 in Parts 1A and Part 2, and Day 181 in Part 3); has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1); and has agreed to continue adequate contraception or abstinence through 3 months following the second injection (Day 29 in Part 1A and Part 2, and Day 181 in Part 3).\n\nFor Part 1B:\n\n* Participants must have been previously enrolled in mRNA-1273-P203 study.\n* Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (Open-Label-Day 1) and on the day of the second injection (Open-Label-Day 29).\n\nFor Part 1C-1 Homologous Booster Dose:\n\n* Participants must have been previously enrolled in the mRNA-1273-P203 study, are actively participating in Part 1A or Part 1B and are least 5 months from the last dose.\n* Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of the first injection (BD-Day 1).\n\nPart 1C-2 Heterologous Booster Dose:\n\n* Male or female, 12 to \\< 18 years of age at the time of consent who, in the opinion of the investigator, is in good general health based on review of medical history and screening physical examination AND has completed non-Moderna primary COVID-19 vaccination series under EUA (for example, Pfizer) at least 3 months from consent.\n\nExclusion Criteria:\n\nFor Part 1A, Part 2, and Part 3:\n\n* Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of investigational product (IP) or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection of COVID-19 within 2 weeks prior to administration of IP (Part 2 participants only). For Part 3 participants, known history of SARS-CoV-2 infection within 90 days prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 90 days prior to administration of IP.\n* Travel outside of the United States or home country (Part 2 and Part 3 only) in the 28 days prior to the Screening Visit (Day 0).\n* Pregnant or breastfeeding\n* Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥38.0°Celsius (C)/≥100.4°Farenheit (F). Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.\n* Prior administration of an investigational coronavirus (for example, SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome \\[MERS-CoV\\]) vaccine\n* Current treatment with investigational agents for prophylaxis against COVID-19\n* Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment\n* Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors)\n* History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0)\n* History of illegal substance use or alcohol abuse within the past 2 years. This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of screening.\n* History of a diagnosis or condition that, in the judgment of the Investigator, may affect study endpoint assessment or compromise participant safety, specifically:\n\n * Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection\n * Suspected active hepatitis\n * Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy\n * Dermatologic conditions that could affect local solicited AR assessments\n * History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine\n * Diagnosis of malignancy within the previous 10 years (excluding nonmelanoma skin cancer)\n * Febrile seizures\n* Receipt of:\n\n * Any licensed vaccine within 28 days before the first dose of IP or plans for receipt of any licensed vaccine within 28 days before and/or after each dose of IP.\n * Systemic immunosuppressants or immune-modifying drugs for \\>14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥20 mg/day prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.\n * Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment\n* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study\n* Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study\n* Is an immediate family member or has a household contact who is an employee of the research center or otherwise involved with the conduct of the study\n\nFor Part 1C-1 and Part 1C-2:\n\n* Pregnant or breastfeeding.\n* Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥ 38.0°C/≥ 100.4°F. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.\n* Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.\n* History of a diagnosis or condition (after enrolment in Part 1A) that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety:\n\n * Suspected active hepatitis\n * Has a bleeding disorder that is considered a contraindication to IM injection or phlebotomy\n * Dermatologic conditions that could affect local solicited AR assessments\n * History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine\n * Diagnosis of malignancy (excluding nonmelanoma skin cancer)\n* Receipt of:\n\n • Any authorized or licensed vaccine within 28 days before the first dose of IP or plans for receipt of any licensed vaccine through 28 days following the last dose of IP or any seasonal influenza vaccine within 14 days before the first dose of IP or plans for receipt of any seasonal influenza vaccine 14 days following the last dose of IP.\n* Participated in an interventional clinical study, other than mRNA-1273-P203 study, within 28 days prior to the Screening Visit (Day 0 \\[for Part 1C-1\\], BD-Day 0 \\[for Part 1C-2\\]) or plans to do so while participating in this study.\n\nPart 1C-2 Heterologous Booster Dose:\n\n* Has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of IP or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID 19 within 2 weeks prior to administration of IP."}, 'identificationModule': {'nctId': 'NCT04649151', 'acronym': 'TeenCove', 'briefTitle': 'A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adolescents 12 to <18 Years of Age', 'orgStudyIdInfo': {'id': 'mRNA-1273-P203'}, 'secondaryIdInfos': [{'id': '2023-000382-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1273', 'description': 'Part 1A (Blinded Phase): Participants will receive 2 intramuscular (IM) injections of mRNA-1273 (100 microgram \\[ug\\] each), 28 days apart, on Day 1 and Day 29.\n\nPart 1B (Open-Label Phase): Participants who cross over from placebo in Part 1A to Part 1B will receive 2 IM injections of mRNA-1273 (100 ug each), 28 days apart on Open Label Day 1 and Open Label Day 29.\n\nPart 2 (Open-Label): Participants will receive 2 IM injections of mRNA-1273 (50 ug each), 28 days apart, on Day 1 and Day 29 and may receive a booster dose on Day 149.', 'interventionNames': ['Biological: mRNA-1273']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part 1A (Blinded Phase): Participants will receive 2 IM injections of mRNA-1273 matching placebo, 28 days apart, on Day 1 and Day 29.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1273 BD', 'description': 'Part 1C-1 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, 5 months after the last dose of Part 1A and 1B.\n\nPart 1C-2 (BD Phase): Participants will receive 1 IM injection of mRNA-1273 (50 ug) on BD-Day 1, at least 3 months post-last dose.', 'interventionNames': ['Biological: mRNA-1273']}, {'type': 'EXPERIMENTAL', 'label': 'mRNA-1273.222', 'description': 'Part 3 (Open-Label): Participants will receive up to 2 IM injections of mRNA-1273.222 (50 ug each), 6 months apart, on Day 1 and Day 181.', 'interventionNames': ['Biological: mRNA-1273.222']}], 'interventions': [{'name': 'mRNA-1273', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['mRNA-1273', 'mRNA-1273 BD']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Placebo']}, {'name': 'mRNA-1273.222', 'type': 'BIOLOGICAL', 'description': 'Sterile solution for injection', 'armGroupLabels': ['mRNA-1273.222']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92220', 'city': 'Banning', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research - 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