Trial record 7 of 7 for: C4591001

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Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA
Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18
Years of Age and Older

The safety and scientific validity of this study is the responsibility of the
study sponsor and investigators. Listing a study does not mean it has
been evaluated by the U.S. Federal Government. Read our disclaimer for
details.

ClinicalTrials.gov Identifier: NCT04754594

Recruitment Status : Active, not recruiting
First Posted : February 15, 2021
Last Update Posted : November 24, 2021
Sponsor: BioNTech SE
Collaborator: Pfizer
Information provided by (Responsible Party): BioNTech SE

Study Description

Brief Summary:
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 700 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).

Condition or disease Intervention/treatment Phase

SARS-CoV-2 Infection COVID-19 Biological: BNT162b2 Other: Phase 2 Phase 3
Maternal Immunization Placebo

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.
Study Design
Study Type : Interventional (Clinical Trial)

Actual
343 participants
Enrollment :

Allocation: Randomized

Intervention
Parallel Assignment
Model:

Masking: Triple (Participant, Care Provider, Investigator)

Primary
Prevention
Purpose:

A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED,

OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY,
Official
TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA
Title:
VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN
HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER

Actual Study Start Date : February 16, 2021

Estimated Primary Completion Date : August 24, 2022

Estimated Study Completion Date : August 24, 2022

Arms and Interventions

Arm Intervention/treatment
Experimental: BNT162b2 Biological: BNT162b2
2 doses Intramuscular Injection
Placebo Comparator: Placebo Other: Placebo
2 doses Intramuscular Injection

Outcome Measures

Primary Outcome Measures :

1. Percentage of maternal participants reporting: Local reactions [ Time Frame: For 7
Days after Dose 1 and Dose 2 ]

Pain at the injection site, redness, and swelling as self-reported on electronic diaries
 2. Percentage of maternal participants reporting systemic events [ Time Frame: For 7
days after Dose 1 and Dose 2 ]

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain,
and new or worsened joint pain as self-reported on electronic diaries.

3. Percentage of maternal participants reporting adverse events [ Time Frame: From

Dose 1 through 1 month after Dose 2 ]

As elicited by investigational site staff

4. Percentage of maternal participants reporting serious adverse events

[ Time Frame: From Dose 1 through 6 months after delivery ]

As elicited by investigational site staff

5. Demonstrate immunobridging of immune response in pregnant women compared to

nonpregnant female participants from the C4591001 study without evidence of past
SARS-CoV-2 infection. [ Time Frame: 1 month after Dose 2 ]

GMR, estimated by the ratio of the geometric mean of SARS CoV 2 neutralizing
titers in pregnant women to those in nonpregnant female participants

6. Demonstrate immunobridging of immune response in pregnant women compared to

nonpregnant female participants from the C4591001 study with and without evidence
of prior SARS-CoV-2 infection [ Time Frame: 1 month after Dose 2 ]

GMR, estimated by the ratio of the geometric mean of SARS CoV 2 neutralizing
titers in pregnant women to those in nonpregnant female participants

Secondary Outcome Measures :

1. Confirmed COVID 19 in participants without evidence of infection prior to
vaccination [ Time Frame: 7 days after Dose 2 through 1 month after delivery ]

1000 person years of follow-up

2. Confirmed COVID 19 in participants with and without evidence of infection prior to

vaccination. [ Time Frame: 7 days after Dose 2 through 1 month after delivery ]

1000 person years of follow-up

Eligibility Criteria

Ages Eligible for Study: Child, Adult, Older Adult

Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using
the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754594

Locations
Hide 82 study locations

United States, Alabama

Children's of Alabama
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Women & Infant Center
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama, United States, 35233
MedPharmics
Mobile, Alabama, United States, 36608

United States, Arizona

Arrowhead Hospital
Glendale, Arizona, United States, 85308
Abrazo West Campus Hospital
Goodyear, Arizona, United States, 85395
St. Joseph Hospital
Phoenix, Arizona, United States, 85013
 MedPharmics, LLC
Phoenix, Arizona, United States, 85015

United States, California

Matrix Clinical Research.
Huntington Park, California, United States, 90255
Matrix Clinical Research
Huntington Park, California, United States, 90255
Chemidox Clinical Trials Inc.
Lancaster, California, United States, 93534
East LA Doctors Hospital
Los Angeles, California, United States, 90023
Matrix Clinical Research
Los Angeles, California, United States, 90057

United States, Florida

Axcess Medical Research
Loxahatchee Groves, Florida, United States, 33470

United States, Idaho

Idaho Falls Pediatrics
Ammon, Idaho, United States, 83406
Bingham Memorial Hospital
Blackfoot, Idaho, United States, 83221
Idaho Falls Pediatrics
Idaho Falls, Idaho, United States, 83402
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States, 83404
Mountain View Hospital
Idaho Falls, Idaho, United States, 83404

United States, Michigan

Covenant Healthcare
Saginaw, Michigan, United States, 48604
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States, 48604

United States, Montana

Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Boeson Research (BUT)
Butte, Montana, United States, 59701
 SCL St. James Healthcare Hospital
Butte, Montana, United States, 59701
Marcus Daly Memorial Hospital
Hamilton, Montana, United States, 59840
Providence St. Patrick Hospital
Missoula, Montana, United States, 59802
The Birth Center
Missoula, Montana, United States, 59803
Boeson Research
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59804
Community Physicians Group-Maternal Fetal Medicine
Missoula, Montana, United States, 59804
St. Luke Community Healthcare Hospital
Ronan, Montana, United States, 59864

United States, Nebraska

Meridian Clinical Research, LLC
Hastings, Nebraska, United States, 68901
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States, 68701

United States, Pennsylvania

Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States, 16506
OBGYN Associates of Erie
Erie, Pennsylvania, United States, 16507
Liberty Family Practice
Erie, Pennsylvania, United States, 16508
Saint Vincent Hospital
Erie, Pennsylvania, United States, 16544

United States, Texas

Tekton Research, Inc.
Austin, Texas, United States, 78705
Tekton Research, Inc.
Austin, Texas, United States, 78745
Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Bedford, Texas, United States, 76022
Ventavia Research Group LLC
Dallas, Texas, United States, 75231
DHR Health Institute for Research and Development
Edinburg, Texas, United States, 78539
 8th Avenue Obstetrics & Gynecology
Fort Worth, Texas, United States, 76104
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, United States, 76104
Ventavia Research Group, LLC
Fort Worth, Texas, United States, 76104
Dr. Ruben Aleman & Associates
McAllen, Texas, United States, 78504
Ventavia Research Group, LLC
Plano, Texas, United States, 75093
Ventavia Research Group, LLC
Weatherford, Texas, United States, 76086
Weatherford OBGYN
Weatherford, Texas, United States, 76086

United States, Utah

University of Utah Hospital
Salt Lake City, Utah, United States, 84132
University of Utah
Salt Lake City, Utah, United States, 84132

United States, Virginia

The Group for Women- MAWC
Norfolk, Virginia, United States, 23502
Tidewater Physicians for Women- MAWC
Norfolk, Virginia, United States, 23502

Brazil
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30.130-100
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Hospital Santa Casa de Misericordia de Sorocaba
Sorocaba, SAO Paulo, Brazil, 18013-000
Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS)
Sorocaba, SAO Paulo, Brazil, 18052-210
Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa
Clinica
Sorocaba, SP, Brazil, 18040-425
HMU SBC - Hospital Municipal Universitário de São Bernardo
São Bernardo do Campo, SÃO Paulo, Brazil, 09624-000
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, SÃO Paulo, Brazil, 09715 - 090
South Africa
WorthWhile Clinical Trials
Benoni, Gauteng, South Africa, 1500
Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre
Johannesburg, Gauteng, South Africa, 2001
Botho Ke Bontle Health Services
Pretoria, Gauteng, South Africa, 0122
Vaccines and Infectious Diseases Analytics (VIDA)
Soweto, Gauteng, South Africa, 2013
Dr Tobias de Villiers
Cape Town, Western CAPE, South Africa, 7500
Tiervlei Trial Centre CC
Cape Town, Western CAPE, South Africa, 7530

Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain, 28660
Hospital de Antequera
Antequera, Malaga, Spain, 29200
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Madrid Puerta del Sur Mostoles
Mostoles, Spain, 28938
Instituto Hispalense de Pediatria- IHP1
Sevilla, Spain, 41012
Servicio de Ginecología del Hospital Quirón Salud Sagrado Corazón
Sevilla, Spain, 41013

United Kingdom
Hampshire Research Hub, Royal South Hants Hospital
Southampton, Hampshire, United Kingdom, SO14 0YG
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom, ME7 5NY
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
University College London Hospitals
London, United Kingdom, NW1 2PG
University College London Hospitals
London, United Kingdom, W1T 7HA
 Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to
Additional Information:
To obtain contact information for a study center near you, click here.

Responsible
BioNTech SE
Party:
ClinicalTrials.g
NCT04754594 History of Changes
ov Identifier:
Other Study ID C4591015
Numbers: 2020-005444-35 ( EudraCT Number )
First Posted: February 15, 2021 Key Record Dates
Last Update
November 24, 2021
Posted:
Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share
Yes
IPD:
Pfizer will provide access to individual de-identified participant data and
related study documents (e.g. protocol, Statistical Analysis Plan (SAP),
Clinical Study Report (CSR)) upon request from qualified researchers,
Plan and subject to certain criteria, conditions, and exceptions. Further details
Description: on Pfizer's data sharing criteria and process for requesting access can be
found at:
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data
_requests.
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data
URL:
_requests

Studies a U.S. FDA-regulated Drug Product: Yes

Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes