To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Public ClinicalTrials.gov record NCT04754594. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04754594
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 726 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2021 (Actual)
- Primary completion
- Jul 15, 2022 (Actual)
- Completion
- Jul 15, 2022 (Actual)
- Last update posted
- Dec 6, 2024
2021 – 2022
United States locations
- U.S. sites
- 56
- U.S. states
- 12
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham Women & Infant Center | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham/Center for Women's Reproductive Health | Birmingham | Alabama | 35233 | — |
| Velocity Clinical Research, Gulfport | Mobile | Alabama | 36608 | — |
| Arrowhead Hospital | Glendale | Arizona | 85308 | — |
| Abrazo West Campus Hospital | Goodyear | Arizona | 85395 | — |
| St. Joseph Hospital | Phoenix | Arizona | 85013 | — |
| MedPharmics, LLC | Phoenix | Arizona | 85015 | — |
| Matrix Clinical Research. | Huntington Park | California | 90255 | — |
| Matrix Clinical Research | Huntington Park | California | 90255 | — |
| Chemidox Clinical Trials Inc. | Lancaster | California | 93534 | — |
| East LA Doctors Hospital | Los Angeles | California | 90023 | — |
| Matrix Clinical Research | Los Angeles | California | 90057 | — |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | — |
| Idaho Falls Pediatrics | Ammon | Idaho | 83406 | — |
| Bingham Memorial Hospital | Blackfoot | Idaho | 83221 | — |
| Idaho Falls Pediatrics | Idaho Falls | Idaho | 83402 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | — |
| Eastern Idaho Regional Medical Center | Idaho Falls | Idaho | 83404 | — |
| Mountain View Hospital | Idaho Falls | Idaho | 83404 | — |
| Covenant Healthcare | Saginaw | Michigan | 48604 | — |
| Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan | 48604 | — |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | — |
| Boeson Research (BUT) | Butte | Montana | 59701 | — |
| SCL St. James Healthcare Hospital | Butte | Montana | 59701 | — |
| Marcus Daly Memorial Hospital | Hamilton | Montana | 59840 | — |
| Providence St. Patrick Hospital | Missoula | Montana | 59802 | — |
| The Birth Center | Missoula | Montana | 59803 | — |
| Boeson Research | Missoula | Montana | 59804 | — |
| Community Medical Center | Missoula | Montana | 59804 | — |
| Community Physicians Group-Maternal Fetal Medicine | Missoula | Montana | 59804 | — |
| St. Luke Community Healthcare Hospital | Ronan | Montana | 59864 | — |
| Meridian Clinical Research, LLC | Hastings | Nebraska | 68901 | — |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | — |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | — |
| OBGYN Associates of Erie | Erie | Pennsylvania | 16507 | — |
| Central Erie Primary Care | Erie | Pennsylvania | 16508 | — |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | — |
| Saint Vincent Hospital | Erie | Pennsylvania | 16544 | — |
| St. David's Medical Center | Austin | Texas | 78705 | — |
| Tekton Research, Inc. | Austin | Texas | 78705 | — |
| Tekton Research, Inc. | Austin | Texas | 78745 | — |
| Texas Health Harris Methodist Hospital Hurst-Euless-Bedford | Bedford | Texas | 76022 | — |
| Ventavia Research Group LLC | Dallas | Texas | 75231 | — |
| DHR Health Institute for Research and Development | Edinburg | Texas | 78539 | — |
| 8th Avenue Obstetrics & Gynecology | Fort Worth | Texas | 76104 | — |
| Baylor Scott & White All Saints Medical Center | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | — |
| Dr. Ruben Aleman & Associates | McAllen | Texas | 78504 | — |
| Ventavia Research Group, LLC | Plano | Texas | 75093 | — |
| Ventavia Research Group, LLC | Weatherford | Texas | 76086 | — |
| Weatherford OBGYN | Weatherford | Texas | 76086 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| The Group for Women- MAWC | Norfolk | Virginia | 23502 | — |
| Tidewater Physicians for Women- MAWC | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04754594, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 6, 2024 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04754594 live on ClinicalTrials.gov.