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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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ClinicalTrials.gov Identifier: NCT04713553
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Brief Summary:

This is a Phase 3, randomized, observer-blind study in healthy individuals.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2):

  • 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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: BNT162b2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : May 11, 2021
Estimated Study Completion Date : May 11, 2021

Arm Intervention/treatment
Experimental: Arm 1
30-microgram dose of US manufactured drug substance (Lot 1)
Biological: BNT162b2
Intramuscular injection

Experimental: Arm 2
30-microgram dose of US manufactured drug substance (Lot 2)
Biological: BNT162b2
Intramuscular injection

Experimental: Arm 3
30-microgram dose of US manufactured drug substance (Lot 3)
Biological: BNT162b2
Intramuscular injection

Experimental: Arm 4
30-microgram dose of EU manufactured drug substance (Lot 4)
Biological: BNT162b2
Intramuscular injection

Experimental: Arm 5
20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
Biological: BNT162b2
Intramuscular injection




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

  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.

  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.

  6. Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff

  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 one of the 30-microgram lots (US or 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 one of the 30-microgram lots (US or 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female participants between the ages of 12 and 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.

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): NCT04713553


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Kaiser Permanente Oakland Recruiting
Oakland, California, United States, 94611
United States, Connecticut
Clinical Research Consulting Recruiting
Milford, Connecticut, United States, 06460
United States, Florida
Indago Research & Health Center, Inc. Recruiting
Hialeah, Florida, United States, 33012
Research Centers of America Recruiting
Hollywood, Florida, United States, 33024
Clinical Neuroscience Solutions Recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
United States, Idaho
Solaris Clinical Research Recruiting
Meridian, Idaho, United States, 83646
United States, Kentucky
Kentucky Pediatric/Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
United States, New Jersey
Amici Clinical Research LLC Recruiting
Raritan, New Jersey, United States, 08869
United States, North Carolina
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45206
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
United States, Texas
Texas Center for Drug Development, Inc. Recruiting
Houston, Texas, United States, 77081
Clinical Trials of Texas, Inc. Recruiting
San Antonio, Texas, United States, 78229
Martin Diagnostic Clinic Recruiting
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic South Recruiting
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04713553    
Other Study ID Numbers: C4591017
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioNTech SE:
COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine