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NCT04754594 · ClinicalTrials.gov registry record · Phase 2
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
A Phase 2 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 2
- Development phase
- 726
- Enrollment target
NCT04754594: Completed Phase 2 study, sponsored by BioNTech SE.
NCT04754594 is a Phase 2 study that has completed, run by BioNTech SE. The registered enrollment target is 726 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (446% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04754594, a Phase 2 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 726 participants
- Enrollment target
Study Summary
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).
Primary Outcome
Pain at injection site, redness \& swelling were recorded by participants in an electronic diary (e-diary). Redness \& swelling were measured \& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \& graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \& necrosis (swelling). Pain at injection site was graded as mild: did not int
Interventions
- OTHER Placebo
- BIOLOGICAL BNT162b2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 726 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2022-07-15 |
| Phase | Phase 2 |
What the finished NCT04754594 record still lists
NCT04754594 is an interventional study that assigns participants to a tested intervention. The registered 726 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 (446% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04754594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04754594 about?
NCT04754594 is a clinical study titled "To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older". Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 ...
What is the current status of trial NCT04754594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 726 participants. The study started on 2021-02-16. Estimated completion is 2022-07-15.
What interventions are being tested in trial NCT04754594?
The interventions under investigation include: Placebo (OTHER), BNT162b2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04754594?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04754594's enrollment target sits among peer trials
726 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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