Trials / Completed
CompletedNCT05096208
Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN HEALTHY ADULTS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,028 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.
Detailed description
This randomized, double-blinded, placebo-controlled Phase 3 study will examine the immune response and the safety and tolerability profiles across 3 manufactured lots of RSVpreF when administered as a single 120 µg dose to healthy adults to demonstrate lot equivalence in manufacturing of RSVpreF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSVpreF (Group 1) | RSV vaccine (RSVpreF) |
| BIOLOGICAL | RSVpreF (Group 2) | RSV vaccine (RSVpreF) |
| BIOLOGICAL | RSVpreF (Group 3) | RSV vaccine (RSVpreF) |
| BIOLOGICAL | Placebo | Placebo |
Timeline
- Start date
- 2021-10-21
- Primary completion
- 2022-04-04
- Completion
- 2022-04-04
- First posted
- 2021-10-27
- Last updated
- 2023-04-12
- Results posted
- 2023-04-12
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05096208. Inclusion in this directory is not an endorsement.