BNT162b2 for COVID-19

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Meridian Clinical Research, LLC, Omaha, NE
COVID-19+4 More
BNT162b2 - Biological
Eligibility
Any Age
All Sexes
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Study Summary

This trial will assess the safety and efficacy of a booster dose of the BNT162b2 vaccine in adults who have received 2 doses of the vaccine at least 6 months prior. The trial will also assess the safety and tolerability of a single dose of the BNT162b2 vaccine in adolescents 12-17 years of age, as compared to a placebo control. BNT162b2, which has been approved by the FDA for a different condition, is now being used to treat COVID-19.

Eligible Conditions

  • COVID-19
  • COVID19 (disease)
  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for COVID-19

Study Objectives

69 Primary · 24 Secondary · Reporting Duration: From the booster dose through the blinded follow-up period, which may be from 2 to 12 months

Month 1
SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants
SSD - The "super" superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants
SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants
SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants
SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants
SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants
Month 1
SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of anti-reference strain immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Noninferiority of anti-reference-strain immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants
SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
SSE - The "super" superiority of anti-Omicron immune responses after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age
Month 1
SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants
SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants
SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants
Month 1
SSD - The "super" superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study
SSD - The noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study
SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study
SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in age-matched participants from the C4591001 study
Month 1
SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection
SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection
Month 1
SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection
SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection
SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection
SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection
SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study
SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study
At each time point
SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants
Day 3
SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only)
Day 7
SSB - Percentage of participants reporting local reactions
SSB - Percentage of participants reporting systemic events
SSD - Percentage of participants reporting local reactions
SSD - Percentage of participants reporting systemic events
Day 7
SSC - Percentage of participants reporting local reactions
SSC - Percentage of participants reporting systemic events
Day 7
SSE - Percentage of participants reporting local reactions
SSE - Percentage of participants reporting systemic events
SSF - Percentage of participants reporting local reactions
SSF - Percentage of participants reporting systemic events
Month 12
Incidence of asymptomatic SARS-CoV-2 infection based on N-binding antibody in participants without evidence of past SARS-CoV-2 infection
SSA - Incidence of asymptomatic SARS-CoV-2 infection based on N-binding antibody in participants without evidence of past SARS-CoV-2 infection
Year 1
SSC - GMFRs in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, for each vaccine and age group
SSC - Immune responses induced by a booster (third) dose of BNT162b2 at 10 µg and 30 µg
SSC - SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs, for each vaccine and age group
Month 12
Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection
Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection
Confirmed severe COVID-19 (based on CDC definition) in participants with and without evidence of past SARS-CoV-2 infection
Confirmed severe COVID-19 (based on CDC definition) in participants without evidence of past SARS-CoV-2 infection
Confirmed severe COVID-19 (based on FDA definition) in participants with and without evidence of past SARS-CoV-2 infection
Confirmed severe COVID-19 (based on FDA definition) period in participants without evidence of past SARS-CoV-2 infection
SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection
SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection
SSA - Confirmed severe COVID-19 (based on CDC definition) in participants with and without evidence of past SARS-CoV-2 infection
SSA - Confirmed severe COVID-19 (based on CDC definition) in participants without evidence of past SARS-CoV-2 infection
SSA - Confirmed severe COVID-19 (based on FDA definition) in participants with and without evidence of past SARS-CoV-2 infection
SSA - Confirmed severe COVID-19 (based on FDA definition) period in participants without evidence of past SARS-CoV-2 infection
Month 1
Percentage of participants reporting adverse events
SSA - Percentage of participants reporting adverse events
SSC - Percentage of participants reporting adverse events
Month 6
Percentage of participants reporting serious adverse events
SSA - Percentage of participants reporting serious adverse events
SSC - Percentage of participants reporting serious adverse events
Month 1
SSD - Percentage of participants reporting adverse events
Month 6
SSD - Percentage of participants reporting serious adverse events
Month 1
SSE - Percentage of participants reporting adverse events
SSF - Percentage of participants reporting adverse events
Month 6
SSE - Percentage of participants reporting serious adverse events
SSF - Percentage of participants reporting serious adverse events
Month 1
SSB - Percentage of participants with elevated troponin I levels
Month 1
SSB - Percentage of participants reporting adverse events
SSB - Percentage of participants reporting serious adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for COVID-19

Trial Design

5 Treatment Groups

BNT162b2
1 of 5
60 µg dose
1 of 5
30 µg dose
1 of 5
10 µg dose
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

10000 Total Participants · 5 Treatment Groups

Primary Treatment: BNT162b2 · Has Placebo Group · Phase 3

BNT162b2
Biological
Experimental Group · 1 Intervention: BNT162b2 · Intervention Types: Biological
60 µg doseExperimental Group · 4 Interventions: Combination (Bivalent) BNT162b2 and BNT162b2 OMI, BNT162b2 OMI, BNT162b2, Combination BNT162b2 and BNT162b2 OMI · Intervention Types: Biological, Biological, Biological, Biological
30 µg doseExperimental Group · 4 Interventions: Combination (Bivalent) BNT162b2 and BNT162b2 OMI, BNT162b2 OMI, BNT162b2, Combination BNT162b2 and BNT162b2 OMI · Intervention Types: Biological, Biological, Biological, Biological
10 µg dose
Biological
Experimental Group · 1 Intervention: BNT162b2 · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pfizer-BioNTech COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the booster dose through the blinded follow-up period, which may be from 2 to 12 months
Closest Location: Meridian Clinical Research, LLC · Omaha, NE
Photo of Omaha 1Photo of Omaha 2Photo of Omaha 3
2005First Recorded Clinical Trial
14 TrialsResearching COVID-19
91 CompletedClinical Trials

Who is running the clinical trial?

PfizerIndustry Sponsor
4,229 Previous Clinical Trials
6,656,581 Total Patients Enrolled
41 Trials studying COVID-19
106,754 Patients Enrolled for COVID-19
BioNTech SELead Sponsor
47 Previous Clinical Trials
72,577 Total Patients Enrolled
17 Trials studying COVID-19
68,457 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,226 Previous Clinical Trials
4,373,430 Total Patients Enrolled
28 Trials studying COVID-19
96,839 Patients Enrolled for COVID-19

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.