To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
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
2 other identifiers
interventional
726
5 countries
90
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Shorter than P25 for phase_2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
February 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2022
CompletedResults Posted
Study results publicly available
December 6, 2024
CompletedDecember 6, 2024
November 1, 2024
1.4 years
February 9, 2021
July 14, 2023
November 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at injection site, redness \& swelling were recorded by participants in an electronic diary (e-diary). Redness \& swelling were measured \& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \& graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper \& Pearson method.
From Day 1 to Day 7 after dose 1
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at injection site, redness \& swelling were recorded by participants in an e-diary. Redness \& swelling were measured \& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \& graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper \& Pearson method.
From Day 1 to Day 7 after dose 2
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 degree Celsius (°C) \& categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C \& \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h \& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h \& severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \& Pearson method.
From Day 1 to Day 7 after dose 1
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 °C \& categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C \& \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: \>2 times in 24 h \& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h \& severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \& Pearson method.
From Day 1 to Day 7 after dose 2
Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)
Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)
Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
1 Month after Dose 2
GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
1 Month after Dose 2
Secondary Outcomes (13)
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection
From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)
Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
- +8 more secondary outcomes
Study Arms (2)
BNT162b2
EXPERIMENTAL2 doses
Placebo
PLACEBO COMPARATOR2 doses
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization
- Participant is willing to give informed consent for her infant to participate in the study
- Capable of giving signed informed consent
You may not qualify if:
- 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.
- 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.
- 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.
- Participants with known or suspected immunodeficiency.
- Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
- Previous vaccination with any coronavirus vaccine.
- Receipt of medications intended to prevent COVID 19.
- 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.
- Current alcohol abuse or illicit drug use.
- 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.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- Previous participation in other studies involving study intervention containing LNPs.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Pfizercollaborator
Study Sites (90)
Children's of Alabama
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham Women & Infant Center
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham, Alabama, 35233, United States
Velocity Clinical Research, Gulfport
Mobile, Alabama, 36608, United States
Arrowhead Hospital
Glendale, Arizona, 85308, United States
Abrazo West Campus Hospital
Goodyear, Arizona, 85395, United States
St. Joseph Hospital
Phoenix, Arizona, 85013, United States
MedPharmics, LLC
Phoenix, Arizona, 85015, United States
Matrix Clinical Research.
Huntington Park, California, 90255, United States
Matrix Clinical Research
Huntington Park, California, 90255, United States
Chemidox Clinical Trials Inc.
Lancaster, California, 93534, United States
East LA Doctors Hospital
Los Angeles, California, 90023, United States
Matrix Clinical Research
Los Angeles, California, 90057, United States
Axcess Medical Research
Loxahatchee Groves, Florida, 33470, United States
Idaho Falls Pediatrics
Ammon, Idaho, 83406, United States
Bingham Memorial Hospital
Blackfoot, Idaho, 83221, United States
Idaho Falls Pediatrics
Idaho Falls, Idaho, 83402, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, 83404, United States
Mountain View Hospital
Idaho Falls, Idaho, 83404, United States
Covenant Healthcare
Saginaw, Michigan, 48604, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Boeson Research (BUT)
Butte, Montana, 59701, United States
SCL St. James Healthcare Hospital
Butte, Montana, 59701, United States
Marcus Daly Memorial Hospital
Hamilton, Montana, 59840, United States
Providence St. Patrick Hospital
Missoula, Montana, 59802, United States
The Birth Center
Missoula, Montana, 59803, United States
Boeson Research
Missoula, Montana, 59804, United States
Community Medical Center
Missoula, Montana, 59804, United States
Community Physicians Group-Maternal Fetal Medicine
Missoula, Montana, 59804, United States
St. Luke Community Healthcare Hospital
Ronan, Montana, 59864, United States
Meridian Clinical Research, LLC
Hastings, Nebraska, 68901, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506, United States
OBGYN Associates of Erie
Erie, Pennsylvania, 16507, United States
Central Erie Primary Care
Erie, Pennsylvania, 16508, United States
Liberty Family Practice
Erie, Pennsylvania, 16508, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
St. David's Medical Center
Austin, Texas, 78705, United States
Tekton Research, Inc.
Austin, Texas, 78705, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Bedford, Texas, 76022, United States
Ventavia Research Group LLC
Dallas, Texas, 75231, United States
DHR Health Institute for Research and Development
Edinburg, Texas, 78539, United States
8th Avenue Obstetrics & Gynecology
Fort Worth, Texas, 76104, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 76104, United States
Ventavia Research Group, LLC
Fort Worth, Texas, 76104, United States
Dr. Ruben Aleman & Associates
McAllen, Texas, 78504, United States
Ventavia Research Group, LLC
Plano, Texas, 75093, United States
Ventavia Research Group, LLC
Weatherford, Texas, 76086, United States
Weatherford OBGYN
Weatherford, Texas, 76086, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
University of Utah
Salt Lake City, Utah, 84132, United States
The Group for Women- MAWC
Norfolk, Virginia, 23502, United States
Tidewater Physicians for Women- MAWC
Norfolk, Virginia, 23502, United States
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30.130-100, Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
HMU SBC - Hospital Municipal Universitário de São Bernardo
São Bernardo do Campo, São Paulo, 09624-000, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715 - 090, Brazil
Hospital Santa Casa de Misericordia de Sorocaba
Sorocaba, São Paulo, 18013-000, Brazil
Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica
Sorocaba, São Paulo, 18040-425, Brazil
Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS)
Sorocaba, São Paulo, 18052-210, Brazil
WorthWhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre
Johannesburg, Gauteng, 2001, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, 0122, South Africa
Vaccines and Infectious Diseases Analytics (VIDA)
Soweto, Gauteng, 2013, South Africa
Dr Tobias de Villiers
Cape Town, Western Cape, 7500, South Africa
Tiervlei Trial Centre CC
Cape Town, Western Cape, 7530, South Africa
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660, Spain
Hospital de Antequera
Antequera, Malaga, 29200, Spain
Hospital Quironsalud Barcelona
Barcelona, 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Clinica Diagonal
Barcelona, 08950, Spain
Hospital Madrid Puerta del Sur Mostoles
Móstoles, 28938, Spain
Instituto Hispalense de Pediatria- IHP1
Seville, 41012, Spain
Hospital Materno-Infantil Quirón
Seville, 41013, Spain
Servicio de Ginecología del Hospital Quirón Salud Sagrado Corazón
Seville, 41013, Spain
Hampshire Research Hub, Royal South Hants Hospital
Southampton, Hampshire, SO14 0YG, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Medway NHS Foundation Trust
Gillingham, KENT, ME7 5NY, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
University College London Hospitals
London, W1T 7HA, United Kingdom
University College London Hospitals
London, WC1E 6EB, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Related Publications (2)
Nana M, Hodson K, Lucas N, Camporota L, Knight M, Nelson-Piercy C. Diagnosis and management of covid-19 in pregnancy. BMJ. 2022 Apr 26;377:e069739. doi: 10.1136/bmj-2021-069739.
PMID: 35473709DERIVEDMohapatra S, Ananda P, Tripathy S. Pharmacological consideration of COVID-19 infection and vaccines in pregnancy. J Chin Med Assoc. 2022 May 1;85(5):537-542. doi: 10.1097/JCMA.0000000000000712. Epub 2022 May 2.
PMID: 35316227DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BioNTech clinical trials patient information
- Organization
- BioNTech SE
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 15, 2021
Study Start
February 16, 2021
Primary Completion
July 15, 2022
Study Completion
July 15, 2022
Last Updated
December 6, 2024
Results First Posted
December 6, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share