Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
NCT05096208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1028
Last updated 2023-04-12
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.
Conditions
Interventions
- BIOLOGICAL
-
RSVpreF (Group 1)
RSV vaccine (RSVpreF)
- BIOLOGICAL
-
RSVpreF (Group 2)
RSV vaccine (RSVpreF)
- BIOLOGICAL
-
RSVpreF (Group 3)
RSV vaccine (RSVpreF)
- BIOLOGICAL
-
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-21
- Primary Completion
- 2022-04-04
- Completion
- 2022-04-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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