History of Changes for Study: NCT04754594

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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Study Record Versions

Version	Submitted Date	Changes
1	February 11, 2021	None (earliest Version on record)
2	March 5, 2021	Recruitment Status, Study Status, Eligibility, Contacts/Locations and Oversight
3	March 30, 2021	Contacts/Locations and Study Status
4	April 9, 2021	Contacts/Locations, Study Status, Eligibility and Outcome Measures
5	May 17, 2021	Study Status and Contacts/Locations
6	May 27, 2021	Contacts/Locations, Study Status and Study Design
7	June 16, 2021	Contacts/Locations, Outcome Measures, Study Description, Study Status and Study Design
8	July 19, 2021	Contacts/Locations, Study Status and Study Design
9	August 16, 2021	Contacts/Locations and Study Status
10	September 13, 2021	Contacts/Locations, Study Status and Study Design
11	September 29, 2021	Contacts/Locations and Study Status
12	October 27, 2021	Contacts/Locations and Study Status
13	November 16, 2021	Recruitment Status, Contacts/Locations, Study Status and Study Design
14	December 17, 2021	Contacts/Locations, Study Status and Study Design
15	January 31, 2022	Contacts/Locations, Study Status and Study Design
16	February 17, 2022	IPDSharing and Study Status
17	May 15, 2022	Contacts/Locations, Study Status, Outcome Measures, Study Design and Study Description
18	August 3, 2022	Study Status, Contacts/Locations, Outcome Measures, Conditions and Study Identification
19	August 22, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Design
20	July 12, 2023	Eligibility, Contacts/Locations, Study Design, Study Status and Study Description
21	July 14, 2023	Quality Control Review has not concluded Returned: August 4, 2023 Outcome Measures, Contacts/Locations, Study Status, Study Design, Document Section
22	August 30, 2023	Quality Control Review has not concluded Returned: September 22, 2023 Adverse Events, Outcome Measures, Study Status, Participant Flow and Study Design
23	October 25, 2023	Quality Control Review has not concluded Returned: November 13, 2023 Study Status, Participant Flow and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	C4591015
Brief Title:	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:	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
Secondary IDs:	2020-005444-35 [EudraCT Number]

Study Status


Record Verification:	March 2021
Overall Status:	Recruiting
Study Start:	February 16, 2021
Primary Completion:	June 27, 2022 [Anticipated]
Study Completion:	June 27, 2022 [Anticipated]

First Submitted:	February 9, 2021
First Submitted that Met QC Criteria:	February 11, 2021
First Posted:	February 15, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	March 5, 2021
Last Update Posted:	March 9, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	BioNTech SE
Responsible Party:	Sponsor
Collaborators:	Pfizer

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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 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.

Conditions


Conditions:	SARS-CoV-2 Infection COVID-19 Maternal Immunization
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	4000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: BNT162b2 2 doses	Biological: BNT162b2 Intramuscular Injection
Placebo Comparator: Placebo 2 doses	Placebo 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 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
6.	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
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


Minimum Age:	0 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: 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. Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study Documented negative HIV antibody test, 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 Exclusion Criteria: 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.

Contacts/Locations


Central Contact Person:	Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials:	Pfizer CT.gov Call Center Study Director Pfizer
Locations:	United States, Arizona
	Arrowhead Hospital [Not yet recruiting] Glendale, Arizona, United States, 85308
	Abrazo West Campus Hospital [Not yet recruiting] Goodyear, Arizona, United States, 85395
	St. Joseph Hospital [Not yet recruiting] Phoenix, Arizona, United States, 85013
	MedPharmics, LLC [Not yet recruiting] Phoenix, Arizona, United States, 85015
	United States, California
	Chemidox Clinical Trials Inc. [Recruiting] Lancaster, California, United States, 93534
	United States, Florida
	Axcess Medical Research [Not yet recruiting] Loxahatchee Groves, Florida, United States, 33470
	United States, Idaho
	Idaho Falls Pediatrics [Recruiting] Ammon, Idaho, United States, 83406
	Idaho Falls Pediatrics [Recruiting] Idaho Falls, Idaho, United States, 83402
	Clinical Research Prime [Recruiting] Idaho Falls, Idaho, United States, 83404
	Eastern Idaho Regional Medical Center [Recruiting] Idaho Falls, Idaho, United States, 83404
	Mountain View Hospital [Recruiting] Idaho Falls, Idaho, United States, 83404
	ASR, LLC [Not yet recruiting] Nampa, Idaho, United States, 83687
	United States, Louisiana
	Medpharmics, LLC [Not yet recruiting] Covington, Louisiana, United States, 70433
	Women's Health & Wellness [Not yet recruiting] Covington, Louisiana, United States, 70433
	MedPharmics LLC [Not yet recruiting] Lafayette, Louisiana, United States, 70508
	MedPharmics, LLC [Not yet recruiting] Metairie, Louisiana, United States, 70006
	United States, Mississippi
	MedPharmics, LLC [Not yet recruiting] Gulfport, Mississippi, United States, 39503
	United States, Montana
	Community Hospital of Anaconda [Recruiting] Anaconda, Montana, United States, 59711
	Boeson Research (BUT) [Recruiting] Butte, Montana, United States, 59701
	SCL St. James Healthcare Hospital [Recruiting] Butte, Montana, United States, 59701
	Marcus Daly Memorial Hospital [Recruiting] Hamilton, Montana, United States, 59840
	Providence St. Patrick Hospital [Recruiting] Missoula, Montana, United States, 59802
	The Birth Center [Recruiting] Missoula, Montana, United States, 59803
	Boeson Research [Recruiting] Missoula, Montana, United States, 59804
	Community Medical Center [Recruiting] Missoula, Montana, United States, 59804
	Community Physicians Group-Maternal Fetal Medicine (Medical Practice) [Recruiting] Missoula, Montana, United States, 59804
	St. Luke Community Healthcare Hospital [Recruiting] Ronan, Montana, United States, 59864
	United States, Nebraska
	Meridian Clinical Research, LLC [Not yet recruiting] Grand Island, Nebraska, United States, 68803
	Meridian Clinical Research, LLC [Not yet recruiting] Hastings, Nebraska, United States, 68901
	Meridian Clinical Research, LLC [Not yet recruiting] Norfolk, Nebraska, United States, 68701
	United States, Pennsylvania
	Allegheny Health and Wellness Pavilion [Not yet recruiting] Erie, Pennsylvania, United States, 16506
	OBGYN Associates of Erie [Not yet recruiting] Erie, Pennsylvania, United States, 16507
	Liberty Family Practice [Not yet recruiting] Erie, Pennsylvania, United States, 16508
	Saint Vincent Hospital [Not yet recruiting] Erie, Pennsylvania, United States, 16544
	United States, Texas
	Tekton Research, Inc. [Not yet recruiting] Austin, Texas, United States, 78705
	Tekton Research, Inc. [Not yet recruiting] Austin, Texas, United States, 78745
	Memorial Hermann Memorial City - Labor and Delivery Unit [Not yet recruiting] Houston, Texas, United States, 77024
	UT Physicians Women's Center at Memorial City [Not yet recruiting] Houston, Texas, United States, 77024
	UTHealth Women's Research Program at Memorial City [Not yet recruiting] Houston, Texas, United States, 77024
	The University of Texas Medical School at Houston [Not yet recruiting] Houston, Texas, United States, 77030
	Ventavia Research Group, LLC [Not yet recruiting] Plano, Texas, United States, 75093
	Tekton Research, Inc. [Not yet recruiting] San Antonio, Texas, United States, 78229
	Ventavia Research Group, LLC [Not yet recruiting] Weatherford, Texas, United States, 76086
	Weatherford OBGYN [Not yet recruiting] Weatherford, Texas, United States, 76086

IPDSharing


Plan to Share IPD:	Yes 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.
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

References


Links:	URL: https://pmiform.com/clinical-trial-info-request?StudyID=C4591015 Description: To obtain contact information for a study center near you, click here.
Available IPD/Information: