Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 4000
Summary
- Conditions
- COVID-19
- Maternal Immunization
- SARS CoV-2 Infection
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The Phase 2 portion of the study will include approximately 350 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed before participants in the...
The Phase 2 portion of the study will include approximately 350 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed before participants in the Phase 3 portion can be enrolled. The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation. Maternal participants who originally received placebo will receive BNT162b2 at defined time points as part of the study.
Tracking Information
- NCT #
- NCT04754594
- Collaborators
- Pfizer
- Investigators
- Study Director: Pfizer CT.gov Call Center Pfizer
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