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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

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ClinicalTrials.gov Identifier: NCT04754594
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Tracking Information
First Submitted Date  ICMJE February 9, 2021
First Posted Date  ICMJE February 15, 2021
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE February 16, 2021
Estimated Primary Completion Date July 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2021)
  • 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
  • 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.
  • Percentage of maternal participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff
  • Percentage of maternal participants reporting serious adverse events [ Time Frame: From Dose 1 through 6 months after delivery ]
    As elicited by investigational site staff
  • Percentage of maternal participants (approx first 600 randomized 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
  • Percentage of maternal participants (approx first 600 randomized participants) reporting systemic events [ Time Frame: For 7 Days after Dose 1 and Dose 2 ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new of worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
  • Percentage of maternal participants (approx first 600 randomized participants) reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    as elicited by investigational site staff
  • Percentage of maternal participants (approx first 600 randomized participants) reporting serious adverse events [ Time Frame: From Dose 1 through 6 months after delivery ]
    As elicited by investigational site staff
  • Demonstrate non inferiority 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
  • Demonstrate non inferiority 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • 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
  • 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.
  • Percentage of maternal participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff
  • Percentage of maternal participants reporting serious adverse events [ Time Frame: From Dose 1 through 6 months after delivery ]
    As elicited by investigational site staff
  • Demonstrate non inferiority 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
  • Demonstrate non inferiority 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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 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 4000 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

The Phase 2 portion of the study will include approximately 350 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 before participants in the Phase 3 portion can be enrolled.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV-2 Infection
  • COVID-19
  • Maternal Immunization
Intervention  ICMJE
  • Biological: BNT162b2
    Intramuscular Injection
  • Other: Placebo
    Intramuscular Injection
Study Arms  ICMJE
  • Experimental: BNT162b2
    2 doses
    Intervention: Biological: BNT162b2
  • Placebo Comparator: Placebo
    2 doses
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2021)
700
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2021)
4000
Estimated Study Completion Date  ICMJE July 25, 2022
Estimated Primary Completion Date July 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Brazil,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04754594
Other Study ID Numbers  ICMJE C4591015
2020-005444-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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, and subject to certain criteria, conditions, and exceptions. Further details 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party BioNTech SE
Study Sponsor  ICMJE BioNTech SE
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account BioNTech SE
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP