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NCT05096208 · ClinicalTrials.gov registry record · Phase 3
Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
A Phase 3 study of RSV, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,028
- Enrollment target
- 18
- Study locations
NCT05096208: Completed Phase 3 study of RSV, sponsored by Pfizer.
NCT05096208 is a Phase 3 study of RSV that has completed, run by Pfizer. The registered enrollment target is 1,028 participants, below the 142,000-participant average among 3 other RSV trials with a reported enrollment target (99% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05096208, a Phase 3 study of RSV, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,028 participants
- Enrollment target
- 18
- Study locations
Study 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.
Primary Outcome
Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSVpreF (Group 1)
- BIOLOGICAL RSVpreF (Group 2)
- BIOLOGICAL RSVpreF (Group 3)
Study Locations (18)
Florida
- Global Health Research Center, Inc. - Miami Lakes
- Precision Clinical Research - Sunrise
- Clinical Site Partners, Inc - Winter Park
- Clinical Site Partners - Winter Park
Texas
- Benchmark Research - Austin
- Texas Center for Drug Development, Inc. - Houston
- DM Clinical Research - Tomball
Utah
- J. Lewis Research, Inc. / Foothill Family Clinic - Salt Lake City
- J. Lewis Research, Inc. / Foothill Family Clinic South - Salt Lake City
Georgia
- Clinical Research Atlanta - Stockbridge
Hawaii
- East-West Medical Research Institute - Honolulu
Idaho
- Clinical Research Prime - Idaho Falls
Kentucky
- Kentucky Pediatric/ Adult Research - Bardstown
Missouri
- Sundance Clinical Research - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,028 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 3 |
What the finished NCT05096208 record still lists
NCT05096208 is an interventional study that assigns participants to a tested intervention. Its 1,028 participants enrollment target places it among the larger protocols in the corpus, below the 142,000-participant average among 3 other RSV trials with a reported enrollment target (99% lower).
The record links to 1 condition, with RSV appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05096208 lists 18 locations in 12 states (Florida, Texas, Utah).
Frequently Asked Questions
What is clinical trial NCT05096208 about?
NCT05096208 is a clinical study titled "Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age". 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.
What is the current status of trial NCT05096208?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,028 participants. The study started on 2021-10-21. Estimated completion is 2022-04-04.
What conditions does trial NCT05096208 study?
This clinical trial studies the following conditions: RSV.
What interventions are being tested in trial NCT05096208?
The interventions under investigation include: Placebo (BIOLOGICAL), RSVpreF (Group 1) (BIOLOGICAL), RSVpreF (Group 2) (BIOLOGICAL), RSVpreF (Group 3) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05096208?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05096208 being conducted?
This trial has 18 study locations across Florida, Georgia, Hawaii, Idaho, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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