Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older
NCT04405076 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 660
Last updated 2022-12-30
Summary
This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in adults 18 years of age or older.
Conditions
Interventions
- BIOLOGICAL
-
Biological: mRNA-1273
Sterile liquid for injection
- BIOLOGICAL
-
0.9% sodium chloride (normal saline) injection
- BIOLOGICAL
-
mRNA-1273.351
Sterile liquid for injection
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED -
ModernaTX, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-05-29
- Primary Completion
- 2021-10-28
- Completion
- 2021-10-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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