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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 is a Phase 2 study that has completed, run by BioNTech SE. The registered enrollment target is 726 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04754594
The ClinicalTrials.gov registry entry for NCT04754594 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 726 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04754594 reports 0 study locations.
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.
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