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A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05472038
Recruitment Status : Completed
First Posted : July 25, 2022
Last Update Posted : April 11, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Tracking Information
First Submitted Date  ICMJE July 15, 2022
First Posted Date  ICMJE July 25, 2022
Last Update Posted Date April 11, 2024
Actual Study Start Date  ICMJE July 26, 2022
Actual Primary Completion Date March 26, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2023)
  • All Cohorts: Percentage of participants reporting local reactions [ Time Frame: For 7 days following the study vaccination ]
    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries
  • All Cohorts: Percentage of participants reporting systemic events [ Time Frame: For 7 days following the study vaccination ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
  • All Cohorts: Percentage of participants reporting adverse events [ Time Frame: For 1 month following the study vaccination ]
    As elicited by the investigational staff
  • All Cohorts: Percentage of participants reporting serious adverse events [ Time Frame: For 6 months following the study vaccination ]
    As elicited by the investigational staff
  • Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: Before study vaccination (Day 1). ]
    As measured at the central laboratory.
  • Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohort 1: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohort 1: Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg [ Time Frame: Before study vaccination (Day 1). ]
    As measured at the central laboratory.
  • Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg.. [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohort 2: % of participants with seroresponse to BNT162b2 Bivalent(WT/OMI BA.4/BA.5) 30µg or 60µg and BNT162b2 Bivalent(WT/OMI BA.1) 30µg or 60µg for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), Omicron(BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination ]
    As measured at the central laboratory.
  • Cohorts 2+3 (>55 yrs) Superiority analysis: Geometric Mean Ratio (GMR) of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohorts 2+3 (>55 yrs) Noninferiority analysis: Differences in %s of participants with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg or BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in participants 18-55 yrs compared to participants >55 yrs. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: Differences in %s of pts with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in pts 18-55 yrs compared to pts >55 yrs. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohort 4: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent [ Time Frame: Before study vaccination (Day 1) ]
    As measured at the central laboratory
  • Cohort 4: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent [ Time Frame: At 1 month after study vaccination ]
    As measured at the central laboratory
  • Cohort 4: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory
  • Cohort 4: % of participants with seroresponse to 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), and reference strain neutralizing antibody levels [ Time Frame: At 1 month after study vaccination ]
    As measured at the central laboratory
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2022)
  • Percentage of participants reporting local reactions [ Time Frame: For 7 days following the study vaccination ]
    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 following the study vaccination ]
    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: For 1 month following the study vaccination ]
    As elicited by the investigational staff
  • Percentage of participants reporting serious adverse events [ Time Frame: For 6 months following the study vaccination ]
    As elicited by the investigational staff
  • Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: Before study vaccination (Day 1). ]
    As measured at the central laboratory.
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. [ Time Frame: From before study vaccination (Day 1) to 6 months after study vaccination. ]
    As measured at the central laboratory.
  • Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: Before study vaccination (Day 1). ]
    As measured at the central laboratory.
  • Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: At 1 week after study vaccination. ]
    As measured at the central laboratory.
  • Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: At 3 months after study vaccination. ]
    As measured at the central laboratory.
  • Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg [ Time Frame: At 6 months after study vaccination. ]
    As measured at the central laboratory.
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. [ Time Frame: From before study vaccination (Day 1) to 3 months after study vaccination. ]
    As measured at the central laboratory.
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. [ Time Frame: From before study vaccination (Day 1) to 1 week after study vaccination. ]
    As measured at the central laboratory.
  • Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 1 week after study vaccination. ]
    As measured at the central laboratory.
  • Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 3 months after study vaccination. ]
    As measured at the central laboratory.
  • Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. [ Time Frame: At 6 months after study vaccination. ]
    As measured at the central laboratory.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2023)
  • Cohorts 2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: Before study vaccination (Day 1). ]
    As measured at the central laboratory.
  • Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). [ Time Frame: From before study vaccination (Day 1) to 1 month after study vaccination. ]
    As measured at the central laboratory.
  • Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels. [ Time Frame: At 1 month after study vaccination. ]
    As measured at the central laboratory.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
Official Title  ICMJE AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 1/2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b RNA-BASED VACCINE CANDIDATES IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS
Brief Summary

The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19.

For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries.

For Cohort 1, this study included participants who were:

  • 18 through 55 years of age
  • have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study.

All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1).

For Cohort 2, this study included participants who were:

  • 12 years of age and older
  • have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.

Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.

Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose.

For Cohort 3, this study included participants who were:

  • 18 years of age and older
  • have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
  • Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.

For Cohort 4, this study is seeking participants who are:

  • 18 through 55 years of age
  • have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study.

All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 1/2/3, randomized, active-controlled, parallel group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Cohort 1 and Cohort 2 (18 years and older): Observer-blind Cohort 2 (12-17 years) and Cohort 3: Open-label Cohort 4: Observer-blind
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV-2 Infection
  • COVID-19
Intervention  ICMJE
  • Biological: BNT162b5 Bivalent (WT/OMI BA.2)
    BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.2]
  • Biological: BNT162b2 Bivalent (WT/OMI BA.1)
    BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.1]
  • Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
    BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
  • Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
    BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
  • Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
    BNT162b6 Wild Type and BNT162b6 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
  • Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
    BNT162b7 Wild Type and BNT162b7 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
  • Biological: BNT162b7 Monovalent (OMI BA.4/BA.5)
    BNT162b7 OMICRON [B.1.1.529 sublineage BA.4/BA.5]
Study Arms  ICMJE
  • Experimental: Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)
    Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.
    Intervention: Biological: BNT162b5 Bivalent (WT/OMI BA.2)
  • Experimental: Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)
    Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.1)
  • Experimental: Cohort 2 -Group 1: 12-17 years; 30 µg
    Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 2 - Group 2: 18-55 years; 30 µg
    Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 2 - Group 3: 18-55 years; 60 µg
    Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 2 - Group 4: >55 years; 30 µg
    Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 2 - Group 5: >55 years; 60 µg
    Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 3 - Group 1: 18-55 years; 30 µg
    Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 3 - Group 2: >55 years; 30 µg
    Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Active Comparator: Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)
    Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
    Intervention: Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
  • Experimental: Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
    Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
    Intervention: Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
  • Experimental: Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
    Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
    Intervention: Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
  • Experimental: Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
    Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
    Intervention: Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
  • Experimental: Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)
    Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1
    Intervention: Biological: BNT162b7 Monovalent (OMI BA.4/BA.5)
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2024)		 1454
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2022)		 200
Actual Study Completion Date  ICMJE March 26, 2024
Actual Primary Completion Date March 26, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age:

    • Cohort 1: 18 through 55 years of age.
    • Cohort 2: 12 years of age and older.
    • Cohort 3: 18 years of age and older.
    • Cohort 4: 18 through 55 years of age.
  2. Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
  3. Healthy participants (stable pre-existing disease permitted).
  4. Capable of giving signed informed consent.
  5. Prior COVID-19 vaccination history:

Cohort 1:

- Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Cohorts 2 and 3:

- Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Cohort 4:

- Received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized Omicron BA.4/BA.5-adapted vaccine and dose level at least 150 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.

Exclusion Criteria:

  1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
  2. Known or suspected immunodeficiency.
  3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  4. Women who are pregnant or breastfeeding.
  5. Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

  6. Immunosuppressants/radiotherapy:

    Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study.

    Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.

  7. Blood/plasma products, immunoglobulin, or monoclonal antibodies:

    Cohorts 1, 2, 3: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study.

    Cohort 4: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of COVID-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.

  8. Other study participation:

    Cohorts 1 and 2: Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.

    Cohorts 3 and 4: Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study.

  9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
  10. Cohort 4 only: History of myocarditis or pericarditis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05472038
Other Study ID Numbers  ICMJE C4591044
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: No
Current Responsible Party BioNTech SE
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BioNTech SE
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account BioNTech SE
Verification Date April 2024

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