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Clinical Trials
NCT04754594

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

Last Updated: 2024-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

726 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-07-15

Brief Summary

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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

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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

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SARS-CoV-2 Infection COVID-19 Maternal Immunization

Keywords

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SARS-CoV-2 Infection COVID-19 Maternal Immunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BNT162b2

2 doses

Group Type EXPERIMENTAL

BNT162b2

Intervention Type BIOLOGICAL

Intramuscular Injection

Placebo

2 doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intramuscular Injection

Interventions

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BNT162b2

Intramuscular Injection

Intervention Type BIOLOGICAL

Placebo

Intramuscular Injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study
4. Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization
5. Participant is willing to give informed consent for her infant to participate in the study
6. Capable of giving signed informed consent

Exclusion Criteria

1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
2. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
4. Participants with known or suspected immunodeficiency.
5. Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
6. Previous vaccination with any coronavirus vaccine.
7. Receipt of medications intended to prevent COVID 19.
8. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time.
9. Current alcohol abuse or illicit drug use.
10. Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw.
11. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
12. Previous participation in other studies involving study intervention containing LNPs.
13. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
14. Participants whose unborn baby has been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Children's of Alabama

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham Women & Infant Center

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham/Center for Women's Reproductive Health

Birmingham, Alabama, United States

Site Status

Velocity Clinical Research, Gulfport

Mobile, Alabama, United States

Site Status

Arrowhead Hospital

Glendale, Arizona, United States

Site Status

Abrazo West Campus Hospital

Goodyear, Arizona, United States

Site Status

St. Joseph Hospital

Phoenix, Arizona, United States

Site Status

MedPharmics, LLC

Phoenix, Arizona, United States

Site Status

Matrix Clinical Research.

Huntington Park, California, United States

Site Status

Matrix Clinical Research

Huntington Park, California, United States

Site Status

Chemidox Clinical Trials Inc.

Lancaster, California, United States

Site Status

East LA Doctors Hospital

Los Angeles, California, United States

Site Status

Matrix Clinical Research

Los Angeles, California, United States

Site Status

Axcess Medical Research

Loxahatchee Groves, Florida, United States

Site Status

Idaho Falls Pediatrics

Ammon, Idaho, United States

Site Status

Bingham Memorial Hospital

Blackfoot, Idaho, United States

Site Status

Idaho Falls Pediatrics

Idaho Falls, Idaho, United States

Site Status

Clinical Research Prime

Idaho Falls, Idaho, United States

Site Status

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, United States

Site Status

Mountain View Hospital

Idaho Falls, Idaho, United States

Site Status

Covenant Healthcare

Saginaw, Michigan, United States

Site Status

Saginaw Valley Medical Research Group, LLC

Saginaw, Michigan, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Boeson Research (BUT)

Butte, Montana, United States

Site Status

SCL St. James Healthcare Hospital

Butte, Montana, United States

Site Status

Marcus Daly Memorial Hospital

Hamilton, Montana, United States

Site Status

Providence St. Patrick Hospital

Missoula, Montana, United States

Site Status

The Birth Center

Missoula, Montana, United States

Site Status

Boeson Research

Missoula, Montana, United States

Site Status

Community Medical Center

Missoula, Montana, United States

Site Status

Community Physicians Group-Maternal Fetal Medicine

Missoula, Montana, United States

Site Status

St. Luke Community Healthcare Hospital

Ronan, Montana, United States

Site Status

Meridian Clinical Research, LLC

Hastings, Nebraska, United States

Site Status