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Trial record 1 of 1 for:    NCT04713553
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A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines 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 : June 11, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Tracking Information
First Submitted Date  ICMJE January 15, 2021
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE February 15, 2021
Estimated Primary Completion Date July 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2021)
  • Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-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
  • GMR of SARS-CoV-2 full-length S-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
  • 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
  • Percentage of participants reporting local reactions [ Time Frame: For 7 days after Dose 1 and Dose 2. For 7 days after Dose 3 (booster). ]
    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
  • Percentage of participants reporting systemic events [ Time Frame: For 7 days after Dose 1 and Dose 2. For 7 days after Dose 3 (booster). ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
  • Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2. From Dose 3 to 1 month after Dose 3. ]
    As elicited by investigational site staff
  • Percentage of participants reporting serious adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2. From Dose 3 to 1 month after Dose 3. ]
    As elicited by investigational site staff
  • Geometric Mean Titers (GMT) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: Before Dose 1, 1 month after Dose 2, before Dose 3, and 1 week after and 1 month after Dose 3. ]
    As measured at the central laboratory
  • Geometric Mean IgG Concentrations (GMC) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: Before Dose 1, 1 month after Dose 2, before Dose 3, and 1 week after and 1 month after Dose 3. ]
    As measured at the central laboratory
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: From 1 month after Dose 2 to 1 week after and 1 month after Dose 3 and from before Dose 3 to 1 week after and 1 month after Dose 3. ]
    As measured at the central laboratory
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [ Time Frame: From 1 month after Dose 2 to 1 week after and 1 month after Dose 3 and from before Dose 3 to 1 week after and 1 month after Dose 3. ]
    As measured at the central laboratory
  • Percentages of participants with seroresponse (based on neutralizing titers) to the reference strain. [ Time Frame: At 1 month after Sode 2, before Dose 3, and 1 week after and 1 month after Dose 3. ]
    As measured at the central laboratory
  • Percentages of participants with seroresponse (based on neutralizing titers) to the B.1.351 strain. [ Time Frame: At 1 month after Sode 2, before Dose 3, and 1 week after and 1 month after Dose 3. ]
    As measured at the central laboratory
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-binding antibody levels between US lots in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ]
    As measured at the central laboratory
  • GMR of SARS-CoV-2 full-length S-binding antibody levels between the EU lot and pooled US lots in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ]
    As measured at the central laboratory
  • 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.
  • 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.
  • Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff
  • Percentage of participants reporting serious adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2021)
  • Geometric Mean Concentrations (GMCs) of SARS-CoV-2 full-length S-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
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-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
  • GMTs 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Geometric Mean Concentrations (GMCs) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with either US, EU or Control lots [ Time Frame: At baseline (before Dose 1) and at 1 month after Dose 2 ]
    As measured at the central laboratory
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with either US, EU or Control lots [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ]
    As measured at the central laboratory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Official Title  ICMJE 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 AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE
Brief Summary

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

The primary 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

The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):

  • Each as a 30-microgram dose
  • Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2
  • In people 18 through 50 years of age
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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
Intervention  ICMJE
  • Biological: BNT162b2
    Intramuscular injection
  • Biological: BNT162b2.B.1.351
    Intramuscular injection
Study Arms  ICMJE
  • Experimental: Arm 1
    30-microgram dose of US manufactured drug substance (Lot 1)
    Intervention: Biological: BNT162b2
  • Experimental: Arm 2
    30-microgram dose of US manufactured drug substance (Lot 2)
    Intervention: Biological: BNT162b2
  • Experimental: Arm 3
    30-microgram dose of US manufactured drug substance (Lot 3)
    Intervention: Biological: BNT162b2
  • Experimental: Arm 4
    30-microgram dose of EU manufactured drug substance (Lot 4)
    Intervention: Biological: BNT162b2
  • Experimental: Arm 5
    20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
    Intervention: Biological: BNT162b2
  • Experimental: Booster 1: BNT162b2
    30-microgram dose
    Intervention: Biological: BNT162b2
  • Experimental: Booster 2: BNT162b2.B.1.351
    30-microgram dose
    Intervention: Biological: BNT162b2.B.1.351
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: February 9, 2021)
1530
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2021)
1280
Estimated Study Completion Date  ICMJE July 22, 2021
Estimated Primary Completion Date July 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
  • Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
  • 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.
  • Primary study: Previous vaccination with any coronavirus vaccine.
  • Booster study: Previous vaccination with any coronavirus vaccine outside of this study.
  • 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.

Additional Exclusion Criteria for the Booster study:

  • Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
  • Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, before or after study intervention administration.
  • Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 50 Years   (Child, 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04713553
Other Study ID Numbers  ICMJE C4591017
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
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 June 2021

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