Phase 3
N=195
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
SARS-CoV-2 Infection · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04368728 ↗Enrolled (actual)
195
Serious AEs
1.3%
Results posted
Mar 2026
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1 — 0; 0; 8.3; 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BNT162b1 (Biological); BNT162b2 (Biological); Placebo (Other); BNT162b2SA (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- BioNTech SE
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1 |
0; 0; 8.3; 0; 16.7; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1 |
0; 0; 8.3; 0; 33.3; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 1 |
0; 8.3; 16.7; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1 |
50.0; 41.7; 50.0; 22.2; 66.7; 33.3 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1 |
0; 0; 0; 0; 0; 4.2 | — |
| PRIMARY Percentage of Participants With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1 |
8.3; 33.3; 54.5; 0; 75.0; 75.0 | — |
| PRIMARY Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1 |
0; 0; 0; 0; 0; 11.1 | — |
| PRIMARY Percentage of Participants With Abnormalities in Hematology Parameters Before Dose 2: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1 |
8.3; 0; 8.3; 0; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1 |
75.0; 75.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1 |
83.3; 75.0; 100.0; 100.0; 91.7; 100.0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Hematology Parameters Before Dose 2: Phase 1 |
50.0; 75.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1 |
58.3; 66.7; 91.7; 88.9; 91.7; 100.0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1 |
0; 91.7; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1 |
0; 91.7; 91.7; 0; 0; 91.7 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2/3 |
3.9; 3.5; 0.7; 0.7; 3.9; 1.0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2/3 |
3.4; 3.5; 0.4; 0.5; 2.6; 0.7 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2/3 |
3.0; 0.6; 1.1; 0.4; 6.6; 0.7 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2/3 |
9.5; 8.5; 0.2; 0.1; 9.8; 0.5 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3 |
30.2; 13.9; 6.0; 5.9 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3 |
1.1; 1.3; 0.2; 2.0; 1.7; 1.3 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2 |
1.1; 1.7; 2.2; 0.6; 2.3; 2.2 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2 |
2.3; 2.3; 2.2; 0; 1.2; 2.8 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2 |
0; 0; 0; 0; 3.4; 1.7 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2 |
8.1; 7.9; 7.7; 0; 7.0; 5.1 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 |
9.1; 6.7; 4.3; 10.0 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 |
1.1; 0.6; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose |
3.5; 1.7; 2.4; 3.0; 0; 0.3 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose |
4.2; 4.0; 4.2; 4.0; 0.3; 4.0 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose |
15.0; 10.8 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose |
0.7; 0.6 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA |
3.3; 6.7; 0; 0; 26.7; 33.3 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA |
3.6; 3.6; 3.6; 0; 32.1; 21.4 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA |
20.0 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA |
3.3 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA |
1.6; 0.3; 0; 0; 1.9; 1.6 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA |
2.8; 1.9; 0.3; 0; 2.8; 2.2 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA |
1.0; 0; 0; 0; 27.8; 21.1 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA |
1.6; 1.6; 0.6; 0; 25.3; 36.1 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA |
14.2 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA |
1.2 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) |
0; 0; 0; 0; 0; 1.9 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) |
0; 0; 4.0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) |
11.5; 3.8; 8.0; 0.0 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) |
0; 1.9; 0; 0 | — |
| PRIMARY COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 |
12.326; 141.596 | — |
| PRIMARY COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) |
3.613; 72.907 | — |
| PRIMARY COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 |
12.444; 139.146 | — |
| PRIMARY COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) |
3.859; 72.068 | — |
| PRIMARY GMR Based on Geometric Mean Titer (N1a) - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3 |
1358.0; 820.3 | — |
| PRIMARY Percentage Difference of Participants Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 |
97.1; 97.3 | — |
| PRIMARY GMR of Neutralizing Titers (E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 |
2466.0; 755.7 | — |
| PRIMARY Percentage Difference of Participants Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 |
99.5; 95.0 | — |
| PRIMARY GMR of Neutralizing Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 |
3580.5; 688.3 | — |
| PRIMARY Percentage Difference of Participants Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 |
99.1; 94.1 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers: Phase 1 |
10.0; 10.0; 10.0; 10.0; 10.0; 12.7 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Severe Acute Respiratory Syndrome Coronavirus 2: S1-binding and RBD-binding IgG Level Assay: Phase 1 |
0.8; 0.9; 1.0; 0.9; 0.6; 294.2 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers: Phase 1 |
1.0; 1.0; 1.0; 1.0; 1.0; 1.3 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 S1-binding and RBD-binding IgG Level Assay: Phase 1 |
1.0; 1.1; 0.8; 1.1; 1.0; 387.6 | — |
| SECONDARY Percentage of Participants Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: Neutralizing Titers: Phase 1 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: S1-binding and RBD-binding IgG Level Assay: Phase 1 |
0.0; 0.0; 0.0; 8.3; 0.0; 100.0 | — |
| SECONDARY GMR Based on Reference Strain NT - Comparison of Participants 12 to 15 Years of Age to Participants 16 to 25 Years of Age- Participants Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3 |
1239.5; 705.1 | — |
| SECONDARY Incidence of Asymptomatic SARS-CoV-2 Infection Per 1000 Person Years Follow-up Without Serological or Virological Evidence (Up to Start of Asymptomatic Surveillance Period) of Past Infection: Phase 3 |
62.663; 100.000 | — |
| SECONDARY Incidence of Asymptomatic SARS-CoV-2 Infection Per 1000 Person Years Follow-up Without Serological or Virological Evidence of Past Infection Based on N-binding Antibody Seroconversion: Phase 3 |
44.220; 93.813 | — |
| SECONDARY COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection 7 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 |
3.863; 73.410 | — |
| SECONDARY COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection 14 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 |
4.034; 73.256 | — |
| SECONDARY COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 |
3.615; 74.324 | — |
| SECONDARY COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 |
4.242; 74.564 | — |
| SECONDARY Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 7 Days After Dose 2: Phase 3 |
0.153; 3.279 | — |
| SECONDARY Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 |
0.504; 1.495 | — |
| SECONDARY Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2: Phase 3 |
0.160; 3.431 | — |
| SECONDARY Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 |
0.530; 1.578 | — |
| SECONDARY COVID-19 Incidence Per 1000 Person-Years of With or Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 |
4.032; 72.180 | — |
| SECONDARY COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 |
4.240; 73.428 | — |
| SECONDARY Percentage Difference of Participants Achieving Seroresponse (Reference Strain) 1 Month After Second Dose in BNT162b2-Naive Participants: Phase 3 |
84.8; 97.3 | — |
| SECONDARY GMR Based on Geometric Mean Titer (Reference Strain) 1 Month After Second Dose in BNT162b2-Naive Participants: Phase 3 |
356.7; 820.3 | — |
| SECONDARY GMR Based on Geometric Mean Titer of SA NT 1 Month After Second Dose of BNT162b2SA to 1 Month After the Second Dose (N2a) of BNT162b2 Naive Participants: Phase 3 |
1358.0; 273.1 | — |
| SECONDARY Percentage Difference of Participants Achieving Seroresponse (N2b) Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 |
97.1; 57.6 | — |
| SECONDARY GMR of Neutralizing Titers (E3a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 |
2562.1; 745.7 | — |
| SECONDARY Percentage Difference of Participants Achieving Seroresponse (E3b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 |
100.0; 95.2 | — |
| SECONDARY GMR of Neutralizing Titers (E4a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 |
1676.0; 686.0 | — |
| SECONDARY Percentage Difference of Participants Achieving Seroresponse (E4b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 |
99.5; 94.0 | — |
| SECONDARY Percentage Difference of Participants Achieving Seroresponse for SA Variant NT Comparison of 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Participants Assigned to Receive 2 Booster Doses of BNT162b2SA: Phase 3 |
100.0; 100.0 | — |
| SECONDARY GMR of SA Variant NT 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Participants Assigned to Receive 2 Booster Doses of BNT1612b2SA: Phase 3 |
4981.2; 1076.5 | — |
| SECONDARY Percentage Difference of Participants Achieving Seroresponse for SA Variant NT: BNT162b2-Experienced Participants Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomized to Receive 1 Booster Dose: Phase 3 |
99.2; 99.6 | — |
| SECONDARY GMR of SA Variant NT: BNT162b2-Experienced Participants Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomized to Receive 1 Booster Dose: Phase 3 |
3536.4; 2453.0 | — |
Summary
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.
The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:
* As a 2-dose (separated by 21 days) schedule;
* At various different dose levels in Phase 1;
* As a booster;
* In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).
The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.
Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity.
The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.
To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.
To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.
Eligibility Criteria
Inclusion Criteria
- Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization.
Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment.
Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization.
Note that participants 30 kg/m2
- Anticipating the need for immunosuppressive treatment within the next 6 months
- Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
- 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.
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids.
- 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 through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation.
- Previous participation in other studies involving study intervention containing lipid nanoparticles.
- Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.
- Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
- Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
- Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Data sourced from ClinicalTrials.gov (NCT04368728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.