History of Changes for Study: NCT04713553

A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 Against COVID-19 in Healthy Participants

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Study Record Versions

Version	Submitted Date	Changes
1	January 15, 2021	None (earliest Version on record)
2	February 9, 2021	Study Status, Eligibility, Outcome Measures, Arms and Interventions, Study Identification, Contacts/Locations, Study Design and Study Description
3	February 23, 2021	Recruitment Status, Study Status and Contacts/Locations
4	March 23, 2021	Study Status and Contacts/Locations
5	May 17, 2021	Study Status and Contacts/Locations
6	June 9, 2021	Outcome Measures, Arms and Interventions, Study Status, Study Identification, Eligibility, Conditions and Study Description
7	August 4, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design
8	February 17, 2022	IPDSharing and Study Status
9	July 18, 2022	Quality Control Review has not concluded Returned: August 12, 2022 Outcome Measures, Study Status, Document Section, Contacts/Locations and Study Design
10	November 30, 2022	Outcome Measures, Study Status, More Information, Adverse Events and Baseline Characteristics

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Study Identification


Unique Protocol ID:	C4591017
Brief Title:	A Phase 3 Study to Evaluate the Lot Consistency, Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 Against COVID-19 in Healthy Adults Participants
Official Title:	A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY ADULTS 18 PARTICIPANTS 12 THROUGH 55 50 YEARS OF AGE
Secondary IDs:

Study Status


Record Verification:	January 2021 February 2021
Overall Status:	Not yet recruiting
Study Start:	January 28, 2021 February 16, 2021
Primary Completion:	April 9 28, 2021 [Anticipated]
Study Completion:	April 9 28, 2021 [Anticipated]

First Submitted:	January 15, 2021
First Submitted that Met QC Criteria:	January 15, 2021
First Posted:	January 19, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	January 15, 2021 February 9, 2021
Last Update Posted:	January 19 February 11, 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 is a Phase 3, randomized, observer-blind study in healthy individuals.

This is a Phase 3, randomized, observer-blind study in healthy individuals. The study will evaluate the Lot consistency, safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2 ) against COVID-19 ):

As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
As a 20-microgram dose, administered from 1 of the manufacturing lots
As a 2-dose (separated by 21 days) schedule
In people 12 through 50 years of age

As one of 5 manufacturing production lots
As a 2-dose (separated by 21 days) schedule
At a single dose level
In adults 18 through 55 years of age

Detailed Description:

Conditions


Conditions:	SARS-CoV-2 Infection COVID-19
Keywords:	COVID-19 Coronavirus Vaccine SARS-CoV-2 RNA Vaccine

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	5
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	1280 1530 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Lot Arm 1 US manufactured drug substance 30-microgram dose of US manufactured drug substance (Lot 1)	Biological: BNT162b2 Intramuscular injection
Experimental: Lot Arm 2 US manufactured drug substance 30-microgram dose of US manufactured drug substance (Lot 2)	Biological: BNT162b2 Intramuscular injection
Experimental: Lot Arm 3 US manufactured drug substance 30-microgram dose of US manufactured drug substance (Lot 3)	Biological: BNT162b2 Intramuscular injection
Experimental: Lot Arm 4 EU manufactured drug substance 30-microgram dose of EU manufactured drug substance (Lot 4)	Biological: BNT162b2 Intramuscular injection
Experimental: Lot Arm 5 Control lot 20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)	Biological: BNT162b2 Intramuscular injection

Outcome Measures


Primary Outcome Measures:
1.	Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-binding or S1-binding antibody levels between US lots (Arms 1, 2 and 3) in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ] As measured at the central laboratory
2.	GMR of SARS-CoV-2 full-length S-binding or S1-binding antibody levels between the EU lot (Arm 4) and pooled US lots (Arms 1, 2, and 3) in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ] As measured at the central laboratory
3.	GMR of SARS-CoV-2 neutralizing antibody levels between the 20-microgram dose group (Arm 5) and the corresponding 30-microgram dose group (Arm 1, 2, or 3) in participants without evidence of SARS-C0V-2 infection during the study. [ Time Frame: At 1 month after Dose 2 ] As measured at the central laboratory
3 4.	Percentage of 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 in electronic diaries.
4 5.	Percentage of 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 in electronic diaries.
5 6.	Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ] As elicited by investigational site staff
6 7.	Percentage of participants reporting serious adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ] As elicited by investigational site staff
Secondary Outcome Measures:
1.	Geometric Mean Concentrations (GMCs) of SARS-CoV-2 full-length S-binding or S1-binding antibody levels in participants vaccinated with either US, EU one of the 30-microgram lots (US or Control lots EU). [ Time Frame: At baseline (before Dose 1) and at 1 month after Dose 2 ] As measured at the central laboratory
2.	Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding or S1-binding antibody levels in participants vaccinated with either US, EU one of the 30-microgram lots (US or Control lots EU) [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ] As measured at the central laboratory
3.	GMCs of SARS CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot) [ Time Frame: At baseline (before Dose 1) and 1 month after Dose 2 ] As measured at the central laboratory
4.	GMFRs of SARS-CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot). [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ] As measured at the central laboratory

Eligibility


Minimum Age:	18 12 Years
Maximum Age:	55 50 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Male or female participants between the ages of 18 12 and 55 50 years, inclusive, at randomization. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Capable of giving personal signed informed consent/have parent(s)/legal guardian 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. Known infection with HIV, HCV, or HBV. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention. 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. . Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Women who are pregnant or breastfeeding. Previous vaccination with any coronavirus vaccine. Receipt of medications intended to prevent COVID-19. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. 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 lipid nanoparticles. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

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, California
	Kaiser Permanente Oakland Oakland, California, United States, 94611
	United States, Connecticut
	Clinical Research Consulting Milford, Connecticut, United States, 06460
	United States, Florida
	Indago Research & Health Center, Inc. Hialeah, Florida, United States, 33012
	Research Centers of America Hollywood, Florida, United States, 33024
	Clinical Neuroscience Solutions Orlando, Florida, United States, 32801
	United States, Georgia
	Clinical Research Atlanta Stockbridge, Georgia, United States, 30281
	United States, Hawaii
	East-West Medical Research Institute Honolulu, Hawaii, United States, 96814
	United States, Idaho
	Solaris Clinical Research Meridian, Idaho, United States, 83646
	United States, Kentucky
	Kentucky Pediatric/Adult Research Bardstown, Kentucky, United States, 40004
	United States, New Jersey
	Amici Clinical Research LLC Raritan, New Jersey, United States, 08869
	United States, Ohio
	Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, United States, 45206
	Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, United States, 45229-3039
	United States, Texas
	Texas Center for Drug Development, Inc. Houston, Texas, United States, 77081
	Martin Diagnostic Clinic Tomball, Texas, United States, 77375
	United States, Utah
	J. Lewis Research, Inc. / Foothill Family Clinic South Salt Lake City, Utah, United States, 84121

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


Citations:
Links:	URL: https://pmiform.com/clinical-trial-info-request?StudyID=C4591017 Description: To obtain contact information for a study center near you, click here.
Available IPD/Information: