Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults. (RENOIR)
Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults. (RENOIR)
Brief Summary:
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of RSVpreF in the prevention of moderate to severe LRTI-RSV in adults.
Detailed Description:
This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the safety, immunogenicity, and efficacy of RSVpreF or placebo (1:1 randomization) in adults. This will be a global study that will span multiple RSV seasons.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a double-blinded, placebo-controlled study.
Primary Purpose: Prevention
Official Title: A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
Actual Study Start Date: August 31, 2021
Estimated Primary Completion Date: June 19, 2024
Estimated Study Completion Date: June 19, 2024
Arm:
- Experimental: RSVpreF vaccine
- Placebo Comparator: Placebo dose
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 30000 |
| Actual Study start date | 31 August 2021 |
| Estimated Study Completion Date | 19 June 2024 |