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NCT04071158 · ClinicalTrials.gov registry record · Phase 2
A Study OF A RSV Vaccine When Given Together With Tdap IN Healthy Nonpregnant Women Aged Between 18 TO 49 Years
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 713
- Enrollment target
NCT04071158: Completed Phase 2 study, sponsored by Pfizer.
NCT04071158 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 713 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (436% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04071158, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 713 participants
- Enrollment target
Study Summary
This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.
Primary Outcome
Percentage of participants achieving Anti-TTd antibody concentrations of \>= 0.1 IU/mL at 1 month after vaccination were reported. The lower limit of quantitation (LLOQ) values for Anti-TTd was 0.05 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) alon
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV Vaccine
- BIOLOGICAL Tdap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2019-12-11 |
| Phase | Phase 2 |
What the finished NCT04071158 record still lists
NCT04071158 is an interventional study that assigns participants to a tested intervention. The registered 713 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (436% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04071158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04071158 about?
NCT04071158 is a clinical study titled "A Study OF A RSV Vaccine When Given Together With Tdap IN Healthy Nonpregnant Women Aged Between 18 TO 49 Years". This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.
What is the current status of trial NCT04071158?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 713 participants. The study started on 2019-10-01. Estimated completion is 2019-12-11.
What interventions are being tested in trial NCT04071158?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV Vaccine (BIOLOGICAL), Tdap (BIOLOGICAL).
Who is sponsoring clinical trial NCT04071158?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04071158's enrollment target sits among peer trials
713 45th of 2000 higher than 1,956 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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