Viewing Study NCT05972993

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Ignite Creation Date: 2025-12-25 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
Study NCT ID: NCT05972993
Status: COMPLETED
Last Update Posted: 2025-05-28
First Post: 2023-08-01
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).', 'eventGroups': [{'id': 'EG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 12, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 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'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}], 'seriousEvents': [{'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Administration Site Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'title': 'Pain at administration site', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Redness at administration site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Swelling at administration site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Lymphadenopathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited administration site events are pain, redness, swelling and lymphadenopathy (axillary swelling/ tenderness on the same side of the body as the site of injection). Any = occurrence of the event regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Solicited Safety Set (SSS) which includes all participants who received at least one dose of investigational products and had solicited events data at the specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Abdominal Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), chills, abdominal pain, vomiting and diarrhea. Fever is defined as body temperature ≥38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on SSS which includes all participants who received at least one dose of investigational products and had solicited events data at the specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 30', 'description': 'An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Exposed set, which included all participants who received the dose of the investigational products.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Below (Baseline) - 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Above (Day 15)', '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'}]}, {'title': 'Within (Baseline) - Above (Day 15)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', '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'}]}, {'title': 'Above (Baseline) - Above (Day 15)', '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'}]}]}, {'title': 'Neutrophils Decrease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Below (Baseline) - Below (Day 15)', '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'}]}, {'title': 'Within (Baseline) - Below (Day 15)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Above (Baseline) - Below (Day 15)', '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'}]}, {'title': 'Below (Baseline) - Within (Day 15)', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Within (Baseline) - Within (Day 15)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}, {'title': 'Above (Baseline) - Within (Day 15)', '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'}]}, {'title': 'Below (Baseline) - Above (Day 15)', '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'}]}, {'title': 'Within (Baseline) - Above (Day 15)', 'measurements': [{'value': '1', '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'}]}, {'title': 'Above (Baseline) - Above (Day 15)', 'measurements': [{'value': '1', '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': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Platelets Decrease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Below (Baseline) - Below (Day 15)', 'measurements': [{'value': '2', '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'}]}, {'title': 'Within (Baseline) - Below (Day 15)', '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'}]}, {'title': 'Above (Baseline) - Below (Day 15)', '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'}]}, {'title': 'Below (Baseline) - Within (Day 15)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', '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'}]}, {'title': 'Within (Baseline) - Within (Day 15)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}, {'title': 'Above (Baseline) - Within (Day 15)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Below (Baseline) - Above (Day 15)', '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'}]}, {'title': 'Within (Baseline) - Above (Day 15)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Above (Baseline) - Above (Day 15)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'WBC Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Below (Baseline) - Below (Day 15)', 'measurements': [{'value': '1', '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'}]}, {'title': 'Within (Baseline) - Below (Day 15)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Above (Baseline) - Below (Day 15)', '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'}]}, {'title': 'Below (Baseline) - Within (Day 15)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}, {'title': 'Within (Baseline) - Within (Day 15)', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}, {'title': 'Above (Baseline) - Within (Day 15)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', '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'}]}, {'title': 'Below (Baseline) - Above (Day 15)', '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'}]}, {'title': 'Within (Baseline) - Above (Day 15)', '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'}]}, {'title': 'Above (Baseline) - Above (Day 15)', 'measurements': [{'value': '1', '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': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 15', 'description': 'The hematological and biochemical parameters included alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, creatinine, direct bilirubin, basophils, eosinophils increase, erytrocytes, hemoglobin decrease, lymphocytes decrease, mean corpuscular hemoglobin, mean corpuscular volume, monocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) increase. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Exposed set. Only participants with data available at specified timepoints were included in analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Medically Attended Adverse Events (MAAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 31', 'description': 'A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. Any = occurrence of the event regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Exposed set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', '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 to Day 31', 'description': 'An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. Any = occurrence of the event regardless of intensity grade.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Exposed set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'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 to Day 31', 'description': 'AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study investigational product administration. 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'upperLimit': '6631.81'}, {'value': '4720.61', 'groupId': 'OG001', 'lowerLimit': '3082.55', 'upperLimit': '7229.14'}, {'value': '4795.20', 'groupId': 'OG002', 'lowerLimit': '3132.57', 'upperLimit': '7340.29'}, {'value': '453.93', 'groupId': 'OG003', 'lowerLimit': '298.47', 'upperLimit': '690.36'}, {'value': '2423.54', 'groupId': 'OG004', 'lowerLimit': '1796.47', 'upperLimit': '3269.50'}, {'value': '3596.47', 'groupId': 'OG005', 'lowerLimit': '2644.67', 'upperLimit': '4890.81'}, {'value': '589.81', 'groupId': 'OG006', 'lowerLimit': '334.04', 'upperLimit': '1041.42'}]}]}, {'title': 'BA.5, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4197.66', 'groupId': 'OG000', 'lowerLimit': 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'lowerLimit': '786.90', 'upperLimit': '2541.66'}, {'value': '1354.49', 'groupId': 'OG001', 'lowerLimit': '793.70', 'upperLimit': '2311.51'}, {'value': '1919.56', 'groupId': 'OG002', 'lowerLimit': '1164.60', 'upperLimit': '3163.94'}, {'value': '444.43', 'groupId': 'OG003', 'lowerLimit': '266.94', 'upperLimit': '739.93'}, {'value': '1547.09', 'groupId': 'OG004', 'lowerLimit': '1100.15', 'upperLimit': '2175.61'}, {'value': '1677.07', 'groupId': 'OG005', 'lowerLimit': '1103.28', 'upperLimit': '2549.28'}, {'value': '540.16', 'groupId': 'OG006', 'lowerLimit': '281.43', 'upperLimit': '1036.75'}]}]}, {'title': 'D614G, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2502.06', 'groupId': 'OG000', 'lowerLimit': '1839.63', 'upperLimit': '3403.03'}, {'value': '1409.21', 'groupId': 'OG001', 'lowerLimit': '931.99', 'upperLimit': '2130.80'}, {'value': '1820.75', 'groupId': 'OG002', 'lowerLimit': '1080.88', 'upperLimit': '3067.05'}, {'value': '1421.87', 'groupId': 'OG003', 'lowerLimit': '706.04', 'upperLimit': '2863.44'}, {'value': '2139.66', 'groupId': 'OG004', 'lowerLimit': '1353.70', 'upperLimit': '3381.96'}, {'value': '1604.51', 'groupId': 'OG005', 'lowerLimit': '1013.28', 'upperLimit': '2540.73'}, {'value': '1702.33', 'groupId': 'OG006', 'lowerLimit': '571.67', 'upperLimit': '5069.18'}]}]}, {'title': 'D614G, D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '8073.12', 'groupId': 'OG000', 'lowerLimit': '5651.68', 'upperLimit': '11532.03'}, {'value': '9990.27', 'groupId': 'OG001', 'lowerLimit': '7096.52', 'upperLimit': '14064.02'}, {'value': '14543.96', 'groupId': 'OG002', 'lowerLimit': '10348.31', 'upperLimit': '20440.70'}, {'value': '1654.35', 'groupId': 'OG003', 'lowerLimit': '1186.60', 'upperLimit': '2306.48'}, {'value': '4661.13', 'groupId': 'OG004', 'lowerLimit': '3673.40', 'upperLimit': '5914.45'}, {'value': '6363.85', 'groupId': 'OG005', 'lowerLimit': '4982.55', 'upperLimit': '8128.08'}, {'value': '2129.10', 'groupId': 'OG006', 'lowerLimit': '1358.56', 'upperLimit': '3336.68'}]}]}, {'title': 'D614G, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6251.22', 'groupId': 'OG000', 'lowerLimit': '4450.68', 'upperLimit': '8780.17'}, {'value': '7726.20', 'groupId': 'OG001', 'lowerLimit': '5712.62', 'upperLimit': '10449.51'}, {'value': '12351.27', 'groupId': 'OG002', 'lowerLimit': '9068.09', 'upperLimit': '16823.16'}, {'value': '1585.37', 'groupId': 'OG003', 'lowerLimit': '1182.26', 'upperLimit': '2125.92'}, {'value': '4633.14', 'groupId': 'OG004', 'lowerLimit': '3382.40', 'upperLimit': '6346.37'}, {'value': '7601.57', 'groupId': 'OG005', 'lowerLimit': '5553.99', 'upperLimit': '10404.02'}, {'value': '2819.98', 'groupId': 'OG006', 'lowerLimit': '1583.73', 'upperLimit': '5021.26'}]}]}, {'title': 'D614G, M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3813.02', 'groupId': 'OG000', 'lowerLimit': '2511.62', 'upperLimit': '5788.74'}, {'value': '3970.88', 'groupId': 'OG001', 'lowerLimit': '2713.92', 'upperLimit': '5810.01'}, {'value': '4645.04', 'groupId': 'OG002', 'lowerLimit': '3267.21', 'upperLimit': '6603.92'}, {'value': '2441.97', 'groupId': 'OG003', 'lowerLimit': '1715.51', 'upperLimit': '3476.06'}, {'value': '4059.06', 'groupId': 'OG004', 'lowerLimit': '3244.67', 'upperLimit': '5077.85'}, {'value': '3342.96', 'groupId': 'OG005', 'lowerLimit': '2541.75', 'upperLimit': '4396.73'}, {'value': '2571.87', 'groupId': 'OG006', 'lowerLimit': '1680.53', 'upperLimit': '3935.97'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 1, 15 and 31, and at Month 6', 'description': 'The analyzed neutralizing titers were SARS-CoV-2 Neutralizing Titer BA.5 and SARS-CoV-2 Neutralizing Titer D614G. D= Day; M= Month.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per Protocol Set (PPS) which included participants who received investigational products, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination, who have neutralizing titer values against pseudovirus bearing S protein data, and without major protocol deviations. Only participants with data available at the specified timepoints were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A: Placebo Combined', 'description': 'Participants received placebo dose administered on Day 1. As described in the analysis plan, participants in the Part A, Group 1: Placebo, Part A, Group 2: Placebo, Part A and Group 3: Placebo were pooled for immunogenicity analyses.'}, {'id': 'OG004', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'title': 'BA.5, D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '9.25', 'groupId': 'OG000', 'lowerLimit': '5.96', 'upperLimit': '14.36'}, {'value': '10.22', 'groupId': 'OG001', 'lowerLimit': '6.68', 'upperLimit': '15.66'}, {'value': '10.38', 'groupId': 'OG002', 'lowerLimit': '6.78', 'upperLimit': '15.90'}, {'value': '0.98', 'groupId': 'OG003', 'lowerLimit': '0.65', 'upperLimit': '1.50'}, {'value': '3.91', 'groupId': 'OG004', 'lowerLimit': '2.90', 'upperLimit': '5.27'}, {'value': '5.80', 'groupId': 'OG005', 'lowerLimit': '4.27', 'upperLimit': '7.89'}, {'value': '0.95', 'groupId': 'OG006', 'lowerLimit': '0.54', 'upperLimit': '1.68'}]}]}, {'title': 'BA.5, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '8.57', 'groupId': 'OG000', 'lowerLimit': '5.61', 'upperLimit': '13.10'}, {'value': '7.37', 'groupId': 'OG001', 'lowerLimit': '5.03', 'upperLimit': '10.78'}, {'value': '13.46', 'groupId': 'OG002', 'lowerLimit': '9.08', 'upperLimit': '19.94'}, {'value': '0.86', 'groupId': 'OG003', 'lowerLimit': '0.59', 'upperLimit': '1.25'}, {'value': '3.43', 'groupId': 'OG004', 'lowerLimit': '2.34', 'upperLimit': '5.03'}, {'value': '4.53', 'groupId': 'OG005', 'lowerLimit': '3.09', 'upperLimit': '6.63'}, {'value': '0.96', 'groupId': 'OG006', 'lowerLimit': '0.47', 'upperLimit': '1.94'}]}]}, {'title': 'BA.5, M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '4.95'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '4.51'}, {'value': '3.74', 'groupId': 'OG002', 'lowerLimit': '2.27', 'upperLimit': '6.17'}, {'value': '0.87', 'groupId': 'OG003', 'lowerLimit': '0.52', 'upperLimit': '1.44'}, {'value': '2.26', 'groupId': 'OG004', 'lowerLimit': '1.61', 'upperLimit': '3.17'}, {'value': '2.45', 'groupId': 'OG005', 'lowerLimit': '1.61', 'upperLimit': '3.72'}, {'value': '0.79', 'groupId': 'OG006', 'lowerLimit': '0.41', 'upperLimit': '1.51'}]}]}, {'title': 'D614G, D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.68', 'groupId': 'OG000', 'lowerLimit': '3.28', 'upperLimit': '6.69'}, {'value': '5.80', 'groupId': 'OG001', 'lowerLimit': '4.12', 'upperLimit': '8.16'}, {'value': '8.44', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '11.86'}, {'value': '0.96', 'groupId': 'OG003', 'lowerLimit': '0.69', 'upperLimit': '1.34'}, {'value': '2.53', 'groupId': 'OG004', 'lowerLimit': '1.99', 'upperLimit': '3.21'}, {'value': '3.45', 'groupId': 'OG005', 'lowerLimit': '2.70', 'upperLimit': '4.41'}, {'value': '1.15', 'groupId': 'OG006', 'lowerLimit': '0.74', 'upperLimit': '1.81'}]}]}, {'title': 'D614G, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.50', 'groupId': 'OG000', 'lowerLimit': '2.49', 'upperLimit': '4.91'}, {'value': '4.32', 'groupId': 'OG001', 'lowerLimit': '3.20', 'upperLimit': '5.85'}, {'value': '6.91', 'groupId': 'OG002', 'lowerLimit': '5.07', 'upperLimit': '9.41'}, {'value': '0.89', 'groupId': 'OG003', 'lowerLimit': '0.66', 'upperLimit': '1.19'}, {'value': '2.43', 'groupId': 'OG004', 'lowerLimit': '1.77', 'upperLimit': '3.32'}, {'value': '3.98', 'groupId': 'OG005', 'lowerLimit': '2.91', 'upperLimit': '5.45'}, {'value': '1.48', 'groupId': 'OG006', 'lowerLimit': '0.83', 'upperLimit': '2.63'}]}]}, {'title': 'D614G, M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '3.03'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '3.04'}, {'value': '2.43', 'groupId': 'OG002', 'lowerLimit': '1.71', 'upperLimit': '3.45'}, {'value': '1.28', 'groupId': 'OG003', 'lowerLimit': '0.90', 'upperLimit': '1.82'}, {'value': '2.01', 'groupId': 'OG004', 'lowerLimit': '1.61', 'upperLimit': '2.51'}, {'value': '1.65', 'groupId': 'OG005', 'lowerLimit': '1.26', 'upperLimit': '2.18'}, {'value': '1.27', 'groupId': 'OG006', 'lowerLimit': '0.83', 'upperLimit': '1.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 15 and 31, and at Month 6 (compared with baseline [Day 1])', 'description': 'The analyzed neutralizing titers were SARS-CoV-2 Neutralizing Titer BA.5 and SARS-CoV-2 Neutralizing Titer D614G. D= Day; M= Month.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'OG001', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'OG002', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'OG003', 'title': 'Part A: Placebo Combined', 'description': 'Participants received placebo dose administered on Day 1. As described in the analysis plan, participants in the Part A, Group 1: Placebo, Part A, Group 2: Placebo, Part A and Group 3: Placebo were pooled for immunogenicity analyses.'}, {'id': 'OG004', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'OG005', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'OG006', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'classes': [{'title': 'BA.5, D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'BA.5, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'BA.5, M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'D614G, D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'D614G, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'D614G, M6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 15 and 31, and at Month 6 (compared with baseline [Day 1])', 'description': 'VRR is expressed as the number of participants with a vaccine response, defined as at least a 4-fold greater neutralizing titer as compared to the titer at Day 1. D= Day; M= Month.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PPS. Only participants with data available at specified timepoints were included in analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'FG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'FG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'FG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'FG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'FG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'FG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'FG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'FG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '18'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '114', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.'}, {'id': 'BG001', 'title': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'BG002', 'title': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received mRNA 30 µg administered on Day 1.'}, {'id': 'BG003', 'title': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'BG004', 'title': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1.'}, {'id': 'BG005', 'title': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'BG006', 'title': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.'}, {'id': 'BG007', 'title': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.'}, {'id': 'BG008', 'title': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '35.8', 'spread': '7.0', 'groupId': 'BG003'}, {'value': '34.7', 'spread': '8.0', 'groupId': 'BG004'}, {'value': '37.2', 'spread': '8.8', 'groupId': 'BG005'}, {'value': '35.7', 'spread': '10.5', 'groupId': 'BG006'}, {'value': '37.7', 'spread': '7.9', 'groupId': 'BG007'}, {'value': '41.5', 'spread': '7.7', 'groupId': 'BG008'}, {'value': '37.7', 'spread': '8.7', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '64', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '50', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'All Other Races', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '108', 'groupId': 'BG009'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The "All Other Races" category (i.e., ASIAN, BLACK OR AFRICAN AMERICAN, NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER, and WHITE, where 0\\<n\\<11) are combined into one category to maintain participant confidentiality and privacy.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-07', 'size': 1957931, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-08T14:47', 'hasProtocol': True}, {'date': '2024-02-15', 'size': 850469, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-08T14:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Data will be collected in an observer-blind manner.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation with sentinel dosing.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-08-01', 'resultsFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-08', 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Solicited Administration Site Events', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited administration site events are pain, redness, swelling and lymphadenopathy (axillary swelling/ tenderness on the same side of the body as the site of injection). Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any Solicited Systemic Events', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), chills, abdominal pain, vomiting and diarrhea. Fever is defined as body temperature ≥38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'Day 1 to Day 30', 'description': 'An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities', 'timeFrame': 'Day 1 to Day 15', 'description': 'The hematological and biochemical parameters included alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, creatinine, direct bilirubin, basophils, eosinophils increase, erytrocytes, hemoglobin decrease, lymphocytes decrease, mean corpuscular hemoglobin, mean corpuscular volume, monocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) increase. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.'}, {'measure': 'Number of Participants With Any Medically Attended Adverse Events (MAAEs)', 'timeFrame': 'Day 1 to Day 31', 'description': 'A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 to Day 31', 'description': 'An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Day 1 to Day 31', 'description': 'AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study investigational product administration. Any = occurrence of the event regardless of intensity grade.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Any MAAEs', 'timeFrame': 'Throughout the study period (Day 1 to Month 6)', 'description': 'A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any SAEs', 'timeFrame': 'Throughout the study period (Day 1 to Month 6)', 'description': 'An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Number of Participants With Any AESIs', 'timeFrame': 'Throughout the study period (Day 1 to Month 6)', 'description': 'AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study investigational product administration. Any = occurrence of the event regardless of intensity grade.'}, {'measure': 'Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains', 'timeFrame': 'At Days 1, 15 and 31, and at Month 6', 'description': 'The analyzed neutralizing titers were SARS-CoV-2 Neutralizing Titer BA.5 and SARS-CoV-2 Neutralizing Titer D614G. D= Day; M= Month.'}, {'measure': 'Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains', 'timeFrame': 'At Days 15 and 31, and at Month 6 (compared with baseline [Day 1])', 'description': 'The analyzed neutralizing titers were SARS-CoV-2 Neutralizing Titer BA.5 and SARS-CoV-2 Neutralizing Titer D614G. D= Day; M= Month.'}, {'measure': 'Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains', 'timeFrame': 'At Days 15 and 31, and at Month 6 (compared with baseline [Day 1])', 'description': 'VRR is expressed as the number of participants with a vaccine response, defined as at least a 4-fold greater neutralizing titer as compared to the titer at Day 1. D= Day; M= Month.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'Master Protocol', 'Omicron', 'mRNA'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, reactogenicity and immune responses of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA-CR-04 vaccine construct when administered in healthy adults previously vaccinated with SARS-CoV-2 mRNA vaccines.', 'detailedDescription': 'There will be dose-escalation in part A of the study with sentinel dosing strategy implemented in each of 3 dosing levels (Group 1; 2; 3). At start, enrollment in Group 1 and 2 will occur simultaneously with the enrolment of 1st participant in Group 1. Each group will consist of 8 sentinel participants, with 6 receiving the mRNA-CR-04 vaccine and 2 receiving a placebo. The safety data from the sentinel participants in both groups, up to Day 8 post-vaccination, will be reviewed by the Internal Safety Review Committee (iSRC).\n\nIf no safety signal is observed, vaccination of the non-sentinel participants in that group will continue. If there are no safety signals observed from the sentinel participants in Group 1 and Group 2, the enrollment and vaccination of the sentinel participants in Group 3 will begin.\n\nPart B of the study will commence only after all Part A participants have completed their Day 15 study visits and the Day 15 interim analysis is completed. In Part B, 2 doses of the mRNA-CR-04 vaccine will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.\n2. Participants, who in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary and study procedures).\n3. Has received 2 doses of primary series and booster dose(s) of an authorized or licensed mRNA COVID-19 vaccine (only Moderna or Pfizer vaccines) with the last booster dose administered between at least 6 and 18 months or more prior to screening and has provided documentation of receiving the vaccination series (e.g., vaccination card).\n4. Negative for SARS-CoV-2 infection by RT-PCR test at screening within 7 days prior to study vaccination.\n5. Is a male or nonpregnant female of 18 to 49 years, inclusive, at screening.\n6. If the participant is a woman of childbearing potential (WOCBP), the participant agrees to practice true abstinence or use at least 1 highly effective form of contraception for at least 30 days prior to study vaccination up to 1 month after study vaccination.\n7. Agrees to refrain from blood or plasma donation from screening and up to 6 months after vaccination.\n8. Is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings.\n\nExclusion Criteria:\n\n1. Has a new onset, clinically significant, abnormal biochemistry or hematology finding \\[defined as greater than or equal to (\\>=) Grade 1\\] at screening (participants with Grade 1 laboratory abnormalities that have been stable for at least 6 months before enrollment may be included in the study).\n2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant's successful completion of the trial.\n3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n4. History of myocarditis, pericarditis, second- and third-degree heart block or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (e.g., due to enterovirus or adenovirus).\n5. Has an acute febrile illness with a temperature \\>=38.0 degree Celsius (°C) or \\>=100.4 degree Fahrenheit (°F) observed by the participant or at the study site within 72 hours prior to study vaccination. Participants with suspected COVID-19 symptoms should be excluded and referred for medical care.\n6. Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous vaccine, or any component of the study vaccine.\n7. Has a body mass index greater than (\\>) 40 Kilograms meter per square (kg/m\\^2).\n8. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 14 days before study vaccination.\n9. Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before the date of screening visit.\n10. Has any self-reported or medically documented clinically significant medical or psychiatric condition. Significant medical conditions include, but are not limited to, the following:\n\n 1. Moderate or severe respiratory disease (e.g., chronic obstructive pulmonary disease, asthma).\n 2. Uncontrolled hypertension, defined as an average systolic blood pressure \\>= 140 millimeters of mercury (mmHg) or an average diastolic blood pressure \\>= 90 mmHg, based on an average of up to 3 blood pressure measurements.\n 3. Clinically significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease).\n 4. Neurological or neurodevelopmental conditions (e.g., Down syndrome, dementia, chronic migraine not controlled by medication, epilepsy, stroke or seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain- Barré syndrome, encephalomyelitis, or transverse myelitis).\n 5. Ongoing malignancy or recent diagnosis of malignancy in the last 5 years (excluding basal cell and squamous cell carcinoma of the skin).\n 6. Tuberculosis or non-tuberculosis mycobacterial infection.\n 7. Autoimmune disease, including hypothyroidism without a defined nonautoimmune cause.\n 8. Immunodeficiency of any cause, including from solid organ transplant, blood, or bone marrow transplant, or use of other immune-weakening medicine.\n 9. Type 1 or 2 diabetes mellitus regardless of disease control.\n11. Has any of the following self-reported or medically documented risk factors for severe COVID-19:\n\n 1. Chronic kidney disease\n 2. Cerebrovascular disease\n 3. Cystic fibrosis\n 4. Chronic liver disease\n 5. Pulmonary fibrosis\n12. Has participated or plans to participate in another investigational study involving any investigational drug or device within 60 days or 5 half-lives, whichever is longer, before study vaccination and throughout the study.\n13. Has received a licensed or authorized non-mRNA COVID-19 vaccine (primary series or booster dose).\n14. Has received or plans to receive any licensed vaccine within 4 weeks before or after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study vaccination.\n15. Is planning to receive an authorized or licensed COVID-19 booster vaccination for the duration of the study (for participants who are not covered by local recommendations to receive booster per current standard of care) OR is planning to receive an authorized or licensed COVID-19 booster vaccination on or before Day 31 of the study (for participants covered by local recommendations to receive booster).\n16. Has received or plans to receive immunoglobulins or any blood or blood products within 90 days before study vaccination and throughout the study.\n17. Reports chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 20 mg/day of prednisone equivalent, allergy injections, immunoglobulins, interferons, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of study vaccination. Note: The use of low-dose topical, ophthalmic, inhaled, intra-articular and intranasal steroid preparations is permitted.\n18. Pregnant or lactating female.\n19. Female participant planning to become pregnant or planning to discontinue contraceptive precautions within 1 month following study vaccination.\n20. Participant is an employee or family member of the investigator or study site personnel."}, 'identificationModule': {'nctId': 'NCT05972993', 'briefTitle': 'A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Exploratory, First Time in Human (FTIH), Observer-blind, Randomized, Controlled Study to Evaluate Safety, Reactogenicity and Immunogenicity of Various Doses of GlaxoSmithKline Biologicals SA's (GSK) Investigational Omicron Variant S Glycoprotein (mRNA-CR-04) Vaccine When Administered Intramuscularly in Healthy Adults 18 to 49 Years of Age", 'orgStudyIdInfo': {'id': '219112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Group 1: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 micrograms (µg) administered on Day 1.', 'interventionNames': ['Biological: mRNA-CR-04 vaccine 10μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A, Group 1: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Group 2: mRNA CR-04 30 µg', 'description': 'Participants received placebo dose administered on Day 1.', 'interventionNames': ['Biological: mRNA-CR-04 vaccine 30μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A, Group 2: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Group 3: mRNA CR-04 100 µg', 'description': 'Participants received mRNA 100 µg administered on Day 1', 'interventionNames': ['Biological: mRNA-CR-04 vaccine 100μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A, Group 3: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: mRNA CR-04 3 µg', 'description': 'Participants received mRNA 3 µg administered on Day 1.', 'interventionNames': ['Biological: mRNA-CR-04 vaccine 3μg']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: mRNA CR-04 10 µg', 'description': 'Participants received mRNA 10 µg administered on Day 1.', 'interventionNames': ['Biological: mRNA-CR-04 vaccine 10μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Participants received placebo dose administered on Day 1.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'mRNA-CR-04 vaccine 10μg', 'type': 'BIOLOGICAL', 'description': 'mRNA CR-04 vaccine, 10 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.', 'armGroupLabels': ['Part A, Group 1: mRNA CR-04 10 µg', 'Part B: mRNA CR-04 10 µg']}, {'name': 'mRNA-CR-04 vaccine 30μg', 'type': 'BIOLOGICAL', 'description': 'mRNA CR-04 vaccine, 30 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.', 'armGroupLabels': ['Part A, Group 2: mRNA CR-04 30 µg']}, {'name': 'mRNA-CR-04 vaccine 100μg', 'type': 'BIOLOGICAL', 'description': 'mRNA CR-04 vaccine, 100 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.', 'armGroupLabels': ['Part A, Group 3: mRNA CR-04 100 µg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.', 'armGroupLabels': ['Part A, Group 1: Placebo', 'Part A, Group 2: Placebo', 'Part A, Group 3: Placebo', 'Part B: Placebo']}, {'name': 'mRNA-CR-04 vaccine 3μg', 'type': 'BIOLOGICAL', 'description': 'mRNA CR-04 vaccine, 3 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1.', 'armGroupLabels': ['Part B: mRNA CR-04 3 µg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32934', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.gsk-studyregister.com/About\\_GSK\\_Patient\\_Level\\_Data\\_Sharing\\_Final\\_13July2023.pdf.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}