A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 3000
Summary
- Conditions
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Part A is observer-blind. During Part B, as their age group becomes Emergency Use Authorization (EUA) eligible, participants may request to be unblinded by scheduling a Participant Decision clinic visit.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 12 years and 17 years
- Gender
- Both males and females
Description
This is a 2-part Phase 2/3 study, with Part A (Blinded Phase) and Part B (Open-label Observational Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer partic...
This is a 2-part Phase 2/3 study, with Part A (Blinded Phase) and Part B (Open-label Observational Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer participants whose age group becomes EUA eligible to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Please access http://TeenCoveStudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.
Tracking Information
- NCT #
- NCT04649151
- Collaborators
- Biomedical Advanced Research and Development Authority
- Investigators
- Not Provided
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