Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30000

Summary

Conditions
Sars Cov 2
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Part A is observer-blind. During Part B participants may request to be unblinded by scheduling a Participant Decision clinic visit.Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a 2-part Phase 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 particip...

This is a 2-part Phase 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 to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Additionally, participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, can choose to receive the second dose of mRNA-1273 during Part B. Please access www.modernatx.com/cove-study for additional information, such as Study Overview, Participation, and Site Locations along with contact numbers for each location for the study.

Tracking Information

NCT #
NCT04470427
Collaborators
  • Biomedical Advanced Research and Development Authority
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Not Provided
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