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

Trial status:Study Complete
Trial ID:
C4591015
NCT ID:
NCT04754594
EudraCT ID:
2020-005444-35
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Study Complete

Results available

Study Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Trial Details

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).

Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b2
    • Phase
    Phase 2/Phase 3
    Type
    Interventional
    Estimated Enrolment
    726
    Estimated Trial Date
    Feb 2021 - Jul 2022

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    Children's of Alabama
    Birmingham, Alabama, United States, 35233
    Status
    Location
    University of Alabama at Birmingham Women & Infant Center
    Birmingham, Alabama, United States, 35233
    Status
    Location
    University of Alabama at Birmingham/Center for Women's Reproductive Health
    Birmingham, Alabama, United States, 35233
    Status
    Location
    Velocity Clinical Research, Gulfport
    Mobile, Alabama, United States, 36608
    Status
    Location
    Arrowhead Hospital
    Glendale, Arizona, United States, 85308
    Status
    Location
    Abrazo West Campus Hospital
    Goodyear, Arizona, United States, 85395
    Status
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