NCT04754594

To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 726 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

The Phase 2 portion of the study will include approximately 200 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. 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.

Conditions

• SARS-CoV-2 Infection
• COVID-19
• Maternal Immunization

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2	Intramuscular Injection
OTHER	Placebo	Intramuscular Injection

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2021-02-15
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

90 sites across 5 countries: United States, Brazil, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study