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NCT04032093 · ClinicalTrials.gov registry record · Phase 2
A Phase 2B Placebo-controlled, Randomized Study OF A Respiratory Syncytial Virus (RSV) Vaccine IN Pregnant Women
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,153
- Enrollment target
NCT04032093: Completed Phase 2 study, sponsored by Pfizer.
NCT04032093 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 1,153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (767% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04032093, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,153 participants
- Enrollment target
Study Summary
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.
Primary Outcome
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prev
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,153 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 2 |
What the finished NCT04032093 record still lists
NCT04032093 is an interventional study that assigns participants to a tested intervention. Its 1,153 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (767% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04032093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04032093 about?
NCT04032093 is a clinical study titled "A Phase 2B Placebo-controlled, Randomized Study OF A Respiratory Syncytial Virus (RSV) Vaccine IN Pregnant Women". This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in the...
What is the current status of trial NCT04032093?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,153 participants. The study started on 2019-08-07. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT04032093?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04032093?
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 NCT04032093's enrollment target sits among peer trials
1,153 19th of 2000 higher than 1,982 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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