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
Study Identifier:
C4591015
ClinicalTrials.gov Identifier:
EudraCT Identifier:
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
Trial details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female
Age
18+
Estimated Trial Date
Feb 2021 - Jul 2022
Protocol 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).
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