Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04798027
Status:
TERMINATED
Last Update Posted:
2025-09-11
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to early termination of this study by the Sponsor prior to full enrollment, the corresponding testing was not conducted, and few planned efficacy outcome measures data were not collected and analysis was not performed.'}}, 'adverseEventsModule': {'timeFrame': 'Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)', 'description': 'SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \\& analyzed for combined population in which the same dose-level groups in Sentinel \\& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 31, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 30, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 34, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 35, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Axillary Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 32, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 48, 'numAffected': 29}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 57, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 64, 'numAffected': 33}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 47, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 56, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'notes': 'Fever/Pyrexia events which occurred 7 days post-vaccination was considered as an unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tooth Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sars-Cov-2 Test Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 37, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscle Tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 45, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 49, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'notes': 'Headache events which occurred 7 days post-vaccination was considered as an unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 44, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 55, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinus Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cystitis Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Group 3: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Post Any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], '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'}]}]}, {'title': 'Post vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], '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'}]}]}, {'title': 'Post vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "AE: any untoward medical occurrence in clinical investigation participant administered medicinal product \\& which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis \\&/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, \\& any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS: participants who received at least one injection of study vaccine were analyzed by the intervention they actually received. Data were collected \\& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \\& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Pain Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Pain Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Pain Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Erythema Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Erythema Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Erythema Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Swelling Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Swelling Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Swelling Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "Solicited reaction (SR): expected adverse reaction (sign or symptom) observed \\& reported under conditions (nature \\& onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, \\& swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS population. Here, "overall number of participants analyzed" = participants with available data for this outcome measure (OM). Data were collected \\& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Fever Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Fever Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Fever Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Headache Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Headache Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Headache Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Malaise Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Malaise Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Malaise Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Myalgia Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Myalgia Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Myalgia Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Arthralgia Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Arthralgia Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Arthralgia Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Chills Post-any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Chills Post-vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Chills Post-vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "SR was an expected adverse reaction (sign or symptom) observed \\& reported under conditions (nature \\& onset) prelisted (i.e., solicited) in CRF \\& considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia \\& chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS population. Here, "overall number of participants analyzed" = participants with available data for this OM. Data were collected \\& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Post Any vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Post vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Post vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on SafAS population. Data were collected \\& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \\& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'SAEs', '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': '0', 'groupId': 'OG006'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'MAAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)', 'description': "SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring \\& rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on SafAS population. Data were collected \\& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \\& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 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'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Partial thromboplastin time: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Partial thromboplastin time: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], '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'}]}]}, {'title': 'Partial thromboplastin time: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], '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'}]}]}, {'title': 'Urine - glucose: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], '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'}]}]}, {'title': 'Urine - glucose: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'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'}]}]}, {'title': 'Urine - glucose: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'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'}]}]}, {'title': 'Urine - protein: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Urine - protein: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Urine - protein: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'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'}]}]}, {'title': 'Urine - blood: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Urine - blood: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2', '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'}]}]}, {'title': 'Urine - blood: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)', 'description': 'Laboratory tests: hemoglobin (male \\& female), above \\& below normal white blood cell, lymphocytes, neutrophils \\& eosinophils, platelet count, creatinine \\& blood urea nitrogen, hyponatremia \\& hypernatremia, hyperkalemia \\& hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \\[LFT\\], bilirubin (normal LFT), prothrombin \\& partial thromboplastin time (seconds), Urine: protein, glucose \\& blood. US FDA "Toxicity Grading Scale for Healthy Adults \\& Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate \\& Grade 3=severe. In the data table, \'number analyzed\'=participants with available data for each specified category \\& \'0\'=none of participants were available for assessment for specified Group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SafAS. "Overall number of participants analyzed" = participants with available data for this OM. Data were collected \\& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'comment': '95% confidence interval (CI) was not computable as the standard deviation (SD) of the sample was 0, since all participants had the same value.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.00', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.00', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.00', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.00', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.00', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.00', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on modified full analysis set (mFAS) population that included all participants who received at least one injection of study intervention, analyzed according to the intervention they actually received, and excludes participants with positive pseudovirus neutralization test results against SARS-CoV-2 D614G variant at Baseline (Day 1). Here, "overall number of participants analyzed" signifies participants with available data for this OM.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '37.6'}, {'value': '29.7', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '59.6'}, {'value': '6.66', 'groupId': 'OG002', 'lowerLimit': '3.61', 'upperLimit': '12.3'}, {'value': '35.2', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '59.0'}, {'value': '27.7', 'groupId': 'OG004', 'lowerLimit': '16.4', 'upperLimit': '46.9'}, {'value': '68.2', 'groupId': 'OG005', 'lowerLimit': '29.0', 'upperLimit': '160'}, {'value': '12.8', 'groupId': 'OG006', 'lowerLimit': '2.52', 'upperLimit': '65.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22 (post-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Group 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '8.88', 'upperLimit': '20.9'}, {'value': '30.1', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '58.6'}, {'value': '6.48', 'groupId': 'OG002', 'lowerLimit': '3.68', 'upperLimit': '11.4'}, {'value': '174', 'groupId': 'OG003', 'lowerLimit': '111', 'upperLimit': '273'}, {'value': '223', 'groupId': 'OG004', 'lowerLimit': '147', 'upperLimit': '336'}, {'value': '416', 'groupId': 'OG005', 'lowerLimit': '303', 'upperLimit': '570'}, {'value': '11.6', 'groupId': 'OG006', 'lowerLimit': '2.43', 'upperLimit': '55.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 36 (post-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.80', 'groupId': 'OG000', 'lowerLimit': '3.07', 'upperLimit': '7.52'}, {'value': '5.93', 'groupId': 'OG001', 'lowerLimit': '2.95', 'upperLimit': '11.9'}, {'value': '1.36', 'groupId': 'OG002', 'lowerLimit': '0.704', 'upperLimit': '2.62'}, {'value': '7.05', 'groupId': 'OG003', 'lowerLimit': '4.21', 'upperLimit': '11.8'}, {'value': '5.55', 'groupId': 'OG004', 'lowerLimit': '3.28', 'upperLimit': '9.37'}, {'value': '13.6', 'groupId': 'OG005', 'lowerLimit': '5.79', 'upperLimit': '32.1'}, {'value': '1.32', 'groupId': 'OG006', 'lowerLimit': '0.682', 'upperLimit': '2.57'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-vaccination) and Day 22 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine medium dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000', 'lowerLimit': '1.83', 'upperLimit': '4.40'}, {'value': '6.03', 'groupId': 'OG001', 'lowerLimit': '3.10', 'upperLimit': '11.7'}, {'value': '1.32', 'groupId': 'OG002', 'lowerLimit': '0.714', 'upperLimit': '2.46'}, {'value': '34.9', 'groupId': 'OG003', 'lowerLimit': '22.3', 'upperLimit': '54.6'}, {'value': '44.6', 'groupId': 'OG004', 'lowerLimit': '29.5', 'upperLimit': '67.3'}, {'value': '83.1', 'groupId': 'OG005', 'lowerLimit': '60.7', 'upperLimit': '114'}, {'value': '1.20', 'groupId': 'OG006', 'lowerLimit': '0.777', 'upperLimit': '1.86'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-vaccination) and Day 36 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': '>=2-fold rise', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '90.4'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '84.4'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '81.3', 'groupId': 'OG003', 'lowerLimit': '63.6', 'upperLimit': '92.8'}, {'value': '74.2', 'groupId': 'OG004', 'lowerLimit': '55.4', 'upperLimit': '88.1'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}, {'title': '>=4-fold rise', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '75.5'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '77.9'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '71.9', 'groupId': 'OG003', 'lowerLimit': '53.3', 'upperLimit': '86.3'}, {'value': '54.8', 'groupId': 'OG004', 'lowerLimit': '36.0', 'upperLimit': '72.7'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (pre-vaccination) and Day 22 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Group 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: Group 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Group 3: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: Group 4: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: Group 5: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: Group 6: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Group 7: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': '>=2-fold rise', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '36.6', 'upperLimit': '77.9'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '52.4', 'upperLimit': '93.6'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '96.6', 'groupId': 'OG003', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}, {'title': '>=4-fold rise', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '67.2'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '86.7'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '96.6', 'groupId': 'OG003', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (pre-vaccination) and Day 36 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '90.4'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '84.4'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '81.3', 'groupId': 'OG003', 'lowerLimit': '63.6', 'upperLimit': '92.8'}, {'value': '74.2', 'groupId': 'OG004', 'lowerLimit': '55.4', 'upperLimit': '88.1'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22 (post-vaccination)', 'description': 'Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '36.6', 'upperLimit': '77.9'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '52.4', 'upperLimit': '93.6'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '96.6', 'groupId': 'OG003', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '12.5', 'groupId': 'OG006', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 36 (post-vaccination)', 'description': 'Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '9.08', 'upperLimit': '12.7'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '8.84', 'upperLimit': '13.1'}, {'value': '9.45', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.1', 'groupId': 'OG003', 'lowerLimit': '8.78', 'upperLimit': '11.7'}, {'value': '10.5', 'groupId': 'OG004', 'lowerLimit': '8.93', 'upperLimit': '12.3'}, {'value': '10.3', 'groupId': 'OG005', 'lowerLimit': '8.52', 'upperLimit': '12.4'}, {'value': '14.4', 'groupId': 'OG006', 'lowerLimit': '7.08', 'upperLimit': '29.4'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '153', 'upperLimit': '375'}, {'value': '372', 'groupId': 'OG001', 'lowerLimit': '192', 'upperLimit': '723'}, {'value': '13.2', 'groupId': 'OG002', 'lowerLimit': '7.84', 'upperLimit': '22.4'}, {'value': '448', 'groupId': 'OG003', 'lowerLimit': '249', 'upperLimit': '805'}, {'value': '476', 'groupId': 'OG004', 'lowerLimit': '279', 'upperLimit': '812'}, {'value': '1618', 'groupId': 'OG005', 'lowerLimit': '984', 'upperLimit': '2660'}, {'value': '34.5', 'groupId': 'OG006', 'lowerLimit': '5.22', 'upperLimit': '228'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '319'}, {'value': '310', 'groupId': 'OG001', 'lowerLimit': '165', 'upperLimit': '582'}, {'value': '14.1', 'groupId': 'OG002', 'lowerLimit': '7.52', 'upperLimit': '26.3'}, {'value': '3618', 'groupId': 'OG003', 'lowerLimit': '2431', 'upperLimit': '5382'}, {'value': '4903', 'groupId': 'OG004', 'lowerLimit': '3326', 'upperLimit': '7228'}, {'value': '10952', 'groupId': 'OG005', 'lowerLimit': '7252', 'upperLimit': '16540'}, {'value': '34.4', 'groupId': 'OG006', 'lowerLimit': '5.31', 'upperLimit': '223'}]}]}, {'title': 'Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '936'}, {'value': '1122', 'groupId': 'OG001', 'lowerLimit': '117', 'upperLimit': '10789'}, {'value': '31.2', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4548', 'groupId': 'OG003', 'lowerLimit': '1090', 'upperLimit': '18981'}, {'value': '1435', 'groupId': 'OG004', 'lowerLimit': '696', 'upperLimit': '2962'}, {'value': '2782', 'groupId': 'OG005', 'lowerLimit': '1138', 'upperLimit': '6799'}, {'value': '96.3', 'groupId': 'OG006', 'lowerLimit': '6.61', 'upperLimit': '1402'}]}]}, {'title': 'Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '23251', 'groupId': 'OG001'}]}]}, {'title': 'Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '384', 'groupId': 'OG003'}, {'value': '1209', 'groupId': 'OG004', 'lowerLimit': '344', 'upperLimit': '4257'}, {'value': '17316', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)', 'description': 'GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'ELU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 22/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '36.2'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '76.9'}, {'value': '1.28', 'groupId': 'OG002', 'lowerLimit': '0.757', 'upperLimit': '2.15'}, {'value': '44.2', 'groupId': 'OG003', 'lowerLimit': '24.4', 'upperLimit': '80.0'}, {'value': '45.3', 'groupId': 'OG004', 'lowerLimit': '26.6', 'upperLimit': '77.3'}, {'value': '158', 'groupId': 'OG005', 'lowerLimit': '93.7', 'upperLimit': '265'}, {'value': '2.39', 'groupId': 'OG006', 'lowerLimit': '0.626', 'upperLimit': '9.13'}]}]}, {'title': 'Day 36/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '34.1'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '62.7'}, {'value': '1.34', 'groupId': 'OG002', 'lowerLimit': '0.706', 'upperLimit': '2.53'}, {'value': '354', 'groupId': 'OG003', 'lowerLimit': '228', 'upperLimit': '551'}, {'value': '466', 'groupId': 'OG004', 'lowerLimit': '318', 'upperLimit': '682'}, {'value': '1067', 'groupId': 'OG005', 'lowerLimit': '712', 'upperLimit': '1601'}, {'value': '2.38', 'groupId': 'OG006', 'lowerLimit': '0.645', 'upperLimit': '8.81'}]}]}, {'title': 'Day 91/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '4.80', 'upperLimit': '150'}, {'value': '135', 'groupId': 'OG001', 'lowerLimit': '9.27', 'upperLimit': '1971'}, {'value': '2.83', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 112/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '481', 'groupId': 'OG003', 'lowerLimit': '115', 'upperLimit': '2009'}, {'value': '131', 'groupId': 'OG004', 'lowerLimit': '61.0', 'upperLimit': '282'}, {'value': '271', 'groupId': 'OG005', 'lowerLimit': '110', 'upperLimit': '670'}, {'value': '5.40', 'groupId': 'OG006', 'lowerLimit': '0.445', 'upperLimit': '65.5'}]}]}, {'title': 'Day 181/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '6.65', 'groupId': 'OG000'}, {'value': '2460', 'groupId': 'OG001'}]}]}, {'title': 'Day 202/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG003'}, {'value': '101', 'groupId': 'OG004', 'lowerLimit': '25.9', 'upperLimit': '392'}, {'value': '125', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)', 'description': 'Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and, \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 22/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '84.6', 'upperLimit': '100'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '93.8', 'groupId': 'OG003', 'lowerLimit': '79.2', 'upperLimit': '99.2'}, {'value': '96.9', 'groupId': 'OG004', 'lowerLimit': '83.8', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '60.0'}]}]}, {'title': 'Day 22/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '98.0'}, {'value': '86.4', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '97.1'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '90.6', 'groupId': 'OG003', 'lowerLimit': '75.0', 'upperLimit': '98.0'}, {'value': '93.8', 'groupId': 'OG004', 'lowerLimit': '79.2', 'upperLimit': '99.2'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '60.0'}]}]}, {'title': 'Day 36/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '78.9', 'upperLimit': '99.9'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '81.5', 'upperLimit': '100'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '88.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '60.0'}]}]}, {'title': 'Day 36/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '97.3'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '98.6'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '88.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '60.0'}]}]}, {'title': 'Day 91/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '100'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Day 91/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '100'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Day 112/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '78.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '85.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '11.8', 'upperLimit': '88.2'}]}]}, {'title': 'Day 112/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '78.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '85.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '11.8', 'upperLimit': '88.2'}]}]}, {'title': 'Day 181/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Day 181/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Day 202/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '76.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Day 202/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '76.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)', 'description': 'Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '6.70', 'upperLimit': '28.1'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '1263'}, {'value': '9.33', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG003', 'lowerLimit': '56.3', 'upperLimit': '1842'}, {'value': '69.5', 'groupId': 'OG004', 'lowerLimit': '31.4', 'upperLimit': '154'}, {'value': '177', 'groupId': 'OG005', 'lowerLimit': '52.7', 'upperLimit': '593'}, {'value': '23.1', 'groupId': 'OG006', 'lowerLimit': '2.91', 'upperLimit': '183'}]}]}, {'title': 'Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '2993', 'groupId': 'OG001'}]}]}, {'title': 'Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004', 'lowerLimit': '25.5', 'upperLimit': '568'}, {'value': '3490', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra- low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 91/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.17', 'groupId': 'OG000', 'lowerLimit': '1.49', 'upperLimit': '6.74'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '2.03', 'upperLimit': '253'}, {'value': '2.18', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 112/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG003', 'lowerLimit': '11.3', 'upperLimit': '368'}, {'value': '13.9', 'groupId': 'OG004', 'lowerLimit': '6.28', 'upperLimit': '30.7'}, {'value': '35.3', 'groupId': 'OG005', 'lowerLimit': '10.5', 'upperLimit': '119'}, {'value': '2.76', 'comment': '95% CI was not computable as the SD of the sample was 0, since all participants had the same value.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 181/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}]}, {'title': 'Day 202/Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG003'}, {'value': '24.1', 'groupId': 'OG004', 'lowerLimit': '5.09', 'upperLimit': '114'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Group 3: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 91/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Day 91/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Day 112/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '68.1', 'upperLimit': '99.8'}, {'value': '90.9', 'groupId': 'OG004', 'lowerLimit': '70.8', 'upperLimit': '98.9'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '40.0', 'groupId': 'OG006', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}, {'title': 'Day 112/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG003', 'lowerLimit': '59.5', 'upperLimit': '98.3'}, {'value': '77.3', 'groupId': 'OG004', 'lowerLimit': '54.6', 'upperLimit': '92.2'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '20.0', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}, {'title': 'Day 181/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Day 181/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Day 202/Day 1: >=2-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '91.7', 'groupId': 'OG004', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}, {'title': 'Day 202/Day 1: >=4-fold rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '83.3', 'groupId': 'OG004', 'lowerLimit': '51.6', 'upperLimit': '97.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'classes': [{'title': 'Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG003', 'lowerLimit': '68.1', 'upperLimit': '99.8'}, {'value': '90.9', 'groupId': 'OG004', 'lowerLimit': '70.8', 'upperLimit': '98.9'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '40.0', 'groupId': 'OG006', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}, {'title': 'Day 181', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Day 202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '91.7', 'groupId': 'OG004', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and \'number analyzed\' = participants with available data for each specified category and \'0\' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'timeFrame': 'Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)', 'description': 'Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected and analyzed for this OM (virologically confirmed COVID-19 like illness) due to discontinuation of the development of the messenger ribonucleic acid (mRNA) COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serologically-confirmed SARS-CoV-2 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'timeFrame': 'Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)', 'description': 'Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected and analyzed for this OM (serologically confirmed SARS-CoV-2 infection) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 1: Group 3: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG004', 'title': 'Cohort 2: Group 5: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'timeFrame': 'Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)', 'description': 'Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected and analyzed for this OM (Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'FG001', 'title': 'Sentinel Cohort: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'FG002', 'title': 'Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'FG003', 'title': 'FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'FG004', 'title': 'FEC Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'FG005', 'title': 'FEC Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'FG006', 'title': 'FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'FG007', 'title': 'FEC Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'FG008', 'title': 'FEC Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '26'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '28'}, {'groupId': 'FG007', 'numSubjects': '29'}, {'groupId': 'FG008', 'numSubjects': '14'}]}, {'type': 'Vaccinated on Day 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '28'}, {'groupId': 'FG007', 'numSubjects': '28'}, {'groupId': 'FG008', 'numSubjects': '14'}]}, {'type': 'Vaccinated on Day 22', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'comment': 'Only FEC Cohort 2 participants received second dose of study vaccine at Day 22.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Only FEC Cohort 2 participants received second dose of study vaccine at Day 22.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Only FEC Cohort 2 participants received second dose of study vaccine at Day 22.', 'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'Safety Analysis Set (SafAS)', 'comment': 'Participants who had received at least one injection of study intervention and were analyzed according to the study intervention they actually received.', 'achievements': [{'comment': "8 participants of 'Sentinel Cohort: SARS-CoV-2 Vaccine low dose' received ultra-low dose and were included in arm 'Sentinel Cohort: SARS-CoV-2 Vaccine ultra-low dose' for safety analysis.", 'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'comment': "9 participants of 'FEC Cohort 2: SARS-CoV-2 Vaccine ultra-low dose' received ultra-low dose in arm 'FEC Cohort 1: SARS-CoV-2 Vaccine ultra-low dose' and were included in that arm for safety analysis.", 'groupId': 'FG003', 'numSubjects': '36'}, {'comment': "9 participants of 'FEC Cohort 2: SARS-CoV-2 Vaccine low dose' received low dose in arm 'FEC Cohort 1: SARS-CoV-2 Vaccine low dose' and were included in that arm for safety analysis.", 'groupId': 'FG004', 'numSubjects': '34'}, {'comment': "5 participants of 'FEC Cohort 2: Placebo' received dose in FEC Cohort 1: Placebo and were included in that arm for safety analysis.", 'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '26'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '28'}, {'groupId': 'FG007', 'numSubjects': '29'}, {'groupId': 'FG008', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '25'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'The study was conducted at 17 active sites in 4 countries between 12 Mar 2021 and 27 Jun 2022. Study consisted of 2 cohorts: Sentinel Cohort and Full Enrollment Cohort (FEC). For analysis purpose, Baseline, safety and outcome measure data was planned to be collected, analyzed and reported for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.', 'preAssignmentDetails': 'Participants (aged 18-49 years) in Sentinel Cohort received two vaccinations, 21 days apart. FEC participants were stratified into 2 age groups: younger adult group (18-49 years) and the older adult group (greater than or equal to \\[\\>=\\] 50 years). FEC Cohort 1 participants received a single injection of study vaccine or placebo, while participants in Cohort 2 received two vaccinations (21 days apart). A total of 182 participants were enrolled, of which 180 were vaccinated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '182', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.'}, {'id': 'BG001', 'title': 'Cohort 1: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.'}, {'id': 'BG002', 'title': 'Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.'}, {'id': 'BG003', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.'}, {'id': 'BG004', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Low Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.'}, {'id': 'BG005', 'title': 'Cohort 2: SARS-CoV-2 Vaccine Medium Dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.'}, {'id': 'BG006', 'title': 'Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.15', 'spread': '16.19', 'groupId': 'BG000'}, {'value': '41.96', 'spread': '17.05', 'groupId': 'BG001'}, {'value': '39.77', 'spread': '14.96', 'groupId': 'BG002'}, {'value': '36.21', 'spread': '13.00', 'groupId': 'BG003'}, {'value': '34.96', 'spread': '13.22', 'groupId': 'BG004'}, {'value': '31.00', 'spread': '8.94', 'groupId': 'BG005'}, {'value': '38.79', 'spread': '16.24', 'groupId': 'BG006'}, {'value': '38.01', 'spread': '14.68', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '77', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '105', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '45', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '113', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all enrolled participants according to the intervention to which they were randomized. Data for baseline characteristics was planned to be collected and analyzed for combined population (Full Enrollment Cohort + Sentinel Cohort) in which the same dose-level groups in Sentinel Cohort and Full Enrollment Cohort were pooled for the analysis. Since Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose group received 2 injections; they were presented under Cohort 2 for analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-08', 'size': 1579055, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-28T03:46', 'hasProtocol': True}, {'date': '2022-09-02', 'size': 459372, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-28T03:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'In the FEC: blinding for vaccine group assignment (formulation) of participants, outcome assessors, Investigators, laboratory personnel, and Sponsor study staff. Only study site staff who prepare and administer the vaccine and were not involved with the safety evaluations were unblinded to vaccine group assignment. There was no blinding for injection schedule.\n\nThe Sentinel Cohort was open-label (no blinding).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a sequential group prevention study consisting of a sentinel cohort followed by the Full Enrollment Cohort. There were 3 dose levels (up to 25 participants 18-49 years of age for each dose level) in the Sentinel Cohort, which were done in an open-label fashion with stepwise safety evaluation for each dose level and each vaccination. All sentinel participants received 2 vaccinations, 21 days apart. For the Full Enrollment Cohort (FEC), which was done in a double-blind design participants were stratified into 2 groups based on age at enrollment: the younger adult age group (140 planned participants 18-49 years of age) and the older adult age group (168 planned participants greater than or equal to \\[\\>=\\] 50 years of age). The FEC Cohort 1 (Groups 1 to 3) received a single injection of study intervention while participants in Cohort 2 (Groups 4 to 6) received 2 vaccinations (to be given 21 days apart).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'whyStopped': "Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2023-06-21', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2021-03-11', 'resultsFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2021-03-12', 'dispFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-12-13', 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "AE: any untoward medical occurrence in clinical investigation participant administered medicinal product \\& which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis \\&/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, \\& any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2."}, {'measure': 'Number of Participants With Solicited Injection Site Reactions', 'timeFrame': 'Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "Solicited reaction (SR): expected adverse reaction (sign or symptom) observed \\& reported under conditions (nature \\& onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, \\& swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2."}, {'measure': 'Number of Participants With Solicited Systemic Reactions', 'timeFrame': 'Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "SR was an expected adverse reaction (sign or symptom) observed \\& reported under conditions (nature \\& onset) prelisted (i.e., solicited) in CRF \\& considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia \\& chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2."}, {'measure': 'Number of Participants With Unsolicited Adverse Events', 'timeFrame': 'Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])', 'description': "An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2."}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)', 'timeFrame': 'From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)', 'description': "SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring \\& rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol."}, {'measure': 'Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance', 'timeFrame': 'From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)', 'description': 'Laboratory tests: hemoglobin (male \\& female), above \\& below normal white blood cell, lymphocytes, neutrophils \\& eosinophils, platelet count, creatinine \\& blood urea nitrogen, hyponatremia \\& hypernatremia, hyperkalemia \\& hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \\[LFT\\], bilirubin (normal LFT), prothrombin \\& partial thromboplastin time (seconds), Urine: protein, glucose \\& blood. US FDA "Toxicity Grading Scale for Healthy Adults \\& Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate \\& Grade 3=severe. In the data table, \'number analyzed\'=participants with available data for each specified category \\& \'0\'=none of participants were available for assessment for specified Group.'}, {'measure': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1', 'timeFrame': 'Day 1 (pre-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22', 'timeFrame': 'Day 22 (post-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36', 'timeFrame': 'Day 36 (post-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22', 'timeFrame': 'Day 1 (pre-vaccination) and Day 22 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.'}, {'measure': 'Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36', 'timeFrame': 'Day 1 (pre-vaccination) and Day 36 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.'}, {'measure': 'Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22', 'timeFrame': 'Day 1 (pre-vaccination) and Day 22 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.'}, {'measure': 'Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36', 'timeFrame': 'Day 1 (pre-vaccination) and Day 36 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.'}, {'measure': 'Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22', 'timeFrame': 'Day 22 (post-vaccination)', 'description': 'Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10.'}, {'measure': 'Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36', 'timeFrame': 'Day 36 (post-vaccination)', 'description': 'Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202', 'timeFrame': 'Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)', 'description': 'GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202', 'timeFrame': 'Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)', 'description': 'Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202', 'timeFrame': 'Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)', 'description': 'Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202', 'timeFrame': 'Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202', 'timeFrame': 'Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202', 'timeFrame': 'Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens', 'timeFrame': 'Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)', 'description': 'Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.'}, {'measure': 'Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness', 'timeFrame': 'Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)', 'description': 'Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness.'}, {'measure': 'Number of Participants With Serologically-confirmed SARS-CoV-2 Infection', 'timeFrame': 'Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)', 'description': 'Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure.'}, {'measure': 'Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2', 'timeFrame': 'Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)', 'description': 'Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25380&tenant=MT_SNY_9011', 'label': 'VAW00001 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of the study are:\n\n* To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose.\n* To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group.\n\nThe secondary objectives of the study are:\n\n* To describe binding antibody profile from Day 1 to Day 387 of each study intervention group.\n* To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group.\n* To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection.\n* To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.', 'detailedDescription': "The duration of each participant's participation in the study was approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Aged \\>= 18 years on the day of inclusion.\n* A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:\n* Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.\n\nOR\n\n* Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination.\n\nA participant of childbearing potential must had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention.\n\n* Informed Consent Form had been signed and dated.\n* Participant not eligible to receive, based on local guidance, or if eligible does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination until completion of the key timepoint of Day 43 of follow-up of this study.\n\nExclusion criteria:\n\n* History of COVID-19 disease or prior SARS-CoV-2 infection confirmed serologically.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.\n* Known liver disease or fatty liver.\n* Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from blood work collected at screening visit.\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on Investigator's judgment.\n* Receipt of immunoglobulins, blood or blood-derived products in the past 3 months.\n* Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome coronavirus \\[MERS-CoV\\]).\n* Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines.\n* Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood draw or planned use of such therapy 72 hours prior to study immunogenicity blood draws at Day 22 and Day 36.\n* Residence in a nursing home or long-term care facility.\n* Health care workers providing direct patient care for COVID-19 participants.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04798027', 'acronym': 'VAW00001', 'briefTitle': 'Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older', 'orgStudyIdInfo': {'id': 'VAW00001'}, 'secondaryIdInfos': [{'id': 'U1111-1251-5486', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low dose', 'description': 'Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Sentinel Cohort: SARS-CoV-2 Vaccine Low dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Sentinel Cohort: SARS-CoV-2 Vaccine Medium dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 3']}, {'type': 'EXPERIMENTAL', 'label': 'FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'FEC Cohort 1: SARS-CoV-2 Vaccine Low dose', 'description': 'Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FEC Cohort 1: Placebo', 'description': 'Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.', 'interventionNames': ['Biological: Placebo (0.9% normal saline)']}, {'type': 'EXPERIMENTAL', 'label': 'FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'FEC Cohort 2: SARS-CoV-2 Vaccine Low dose', 'description': 'Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.', 'interventionNames': ['Biological: SARS-CoV-2 mRNA vaccine formulation 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FEC Cohort 2: Placebo', 'description': 'Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.', 'interventionNames': ['Biological: Placebo (0.9% normal saline)']}], 'interventions': [{'name': 'SARS-CoV-2 mRNA vaccine formulation 1', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection', 'armGroupLabels': ['FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low dose', 'FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low dose', 'Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low dose']}, {'name': 'SARS-CoV-2 mRNA vaccine formulation 2', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection', 'armGroupLabels': ['FEC Cohort 1: SARS-CoV-2 Vaccine Low dose', 'FEC Cohort 2: SARS-CoV-2 Vaccine Low dose', 'Sentinel Cohort: SARS-CoV-2 Vaccine Low dose']}, {'name': 'SARS-CoV-2 mRNA vaccine formulation 3', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection', 'armGroupLabels': ['Sentinel Cohort: SARS-CoV-2 Vaccine Medium dose']}, {'name': 'Placebo (0.9% normal saline)', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form: Liquid Route of administration: Intramuscular injection', 'armGroupLabels': ['FEC Cohort 1: Placebo', 'FEC Cohort 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number :8400003', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number :8400002', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number :8400006', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number :8400017', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number :8400007', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number :8400008', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number :8400001', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number :8400010', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29405', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Investigational Site Number :8400004', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number :8400015', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number :8400009', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigational Site Number :8400005', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '4506', 'city': 'Morayfield', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Investigational Site Number :0360003', 'geoPoint': {'lat': -27.10876, 'lon': 152.94907}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Investigational Site Number :0360005', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '3010', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site Number :0360001', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Investigational Site Number :0360002', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '40415-006', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760001', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '79070-900', 'city': 'Campo Grande', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760004', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'zip': '30110-063', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Investigational Site Number :0760003', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '11101', 'city': 'Barrio del Centro', 'country': 'Honduras', 'facility': 'Investigational Site Number :3400002', 'geoPoint': {'lat': 15.61211, 'lon': -87.95243}}, {'zip': '21104', 'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Investigational Site Number :3400001', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}