Phase 3
N=16,349
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
SARS-CoV-2 Infection · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04955626 ↗Enrolled (actual)
16,349
Serious AEs
1.0%
Results posted
Nov 2025
Primary outcome: Primary: SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population — 7.290; 155.303 Number of first Covid-19 cases/1000 PY
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BNT162b2 (Biological); Placebo (Other); BNT162b2 OMI (Biological); Combination BNT162b2 and BNT162b2 OMI (Biological); Combination (Bivalent) BNT162b2 and BNT162b2 OMI (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- BioNTech SE
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population |
7.290; 155.303 | — |
| PRIMARY SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy Population |
8.037; 148.503 | — |
| PRIMARY SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population |
57.377; 158.798 | — |
| PRIMARY SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection at Final Analysis: Evaluable Efficacy Population |
57.118; 151.668 | — |
| PRIMARY SSA: Percentage of Participants Reporting Adverse Events |
26.3; 7.1 | — |
| PRIMARY SSA: Percentage of Participants Reporting Serious Adverse Events (SAE) |
1.4; 0.8; 1.0 | — |
| PRIMARY SSB: Percentage of Participants With Elevated Troponin I Level Pre-Dose; Vaccination 1 |
0.7; 0.5 | — |
| PRIMARY SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 1 |
1.0; 0.6 | — |
| PRIMARY SSB: Percentage of Participants With Elevated Troponin I Level Pre-Vaccination 2 (1 Month After Vaccination 1) |
1.1; 0.3 | — |
| PRIMARY SSB: Percentage of Participants With Elevated Troponin I Level Within 5 Days After Vaccination 2 |
1.5; 0.3 | — |
| PRIMARY SSB: Percentage of Participants With Elevated Troponin I Level 1 Month After Vaccination 2 |
0.7; 0.3 | — |
| PRIMARY SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 |
5.8; 0.5; 4.4; 0.4; 1.1; 0.1 | — |
| PRIMARY SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 |
0.7; 4.6; 0.3; 2.8; 0.4; 1.5 | — |
| PRIMARY SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 |
6.0; 1.9; 4.1; 1.4; 1.7; 0.3 | — |
| PRIMARY SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 |
0.4; 4.3; 0.3; 2.5; 0.1; 1.3 | — |
| PRIMARY SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 1 |
9.4; 10.4 | — |
| PRIMARY SSB: Percentage of Participants Reporting Adverse Events (AEs) 1 Month After Vaccination 2 |
5.6; 7.4 | — |
| PRIMARY SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 1 |
0.1; 0.3 | — |
| PRIMARY SSB: Percentage of Participants Reporting Serious Adverse Events (SAEs) 1 Month After Vaccination 2 |
0; 0.1 | — |
| PRIMARY SSC: Percentage of Participants With Local Reactions Within 7 Days After Booster Dose |
1.3; 6.3; 1.3; 4.7; 0; 1.6 | — |
| PRIMARY SSC: Percentage of Participants With Systemic Events Within 7 Days After Booster Dose |
4.0; 6.3; 2.7; 3.1; 0; 1.6 | — |
| PRIMARY SSC: Percentage of Participants Reporting Adverse Events From Booster Dose Through 1 Month After Booster Dose |
4.0; 7.7 | — |
| PRIMARY SSC: Percentage of Participants Reporting Serious Adverse Events From Booster Dose Through 6 Months After Booster Dose |
0; 1.5 | — |
| PRIMARY SSC: Geometric Mean Titers (GMT) of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Baseline |
1337.2; 1648.4 | — |
| PRIMARY SSC: GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at 1 Month After the Booster Dose |
11672.4; 15680.7 | — |
| PRIMARY SSC: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 1 Month After the Booster Dose |
8.6; 9.5 | — |
| PRIMARY SSC: Percentage of Participants With Seroresponse to Reference-Strain at 1 Month After the Booster Dose |
67.7; 66.7 | — |
| PRIMARY SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 |
3.4; 5.7; 2.5; 7.1; 4.3; 5.4 | — |
| PRIMARY SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 |
5.7; 5.1; 4.1; 4.3; 4.5; 3.6 | — |
| PRIMARY SSD: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 |
4.5; 1.3; 3.2; 0; 0; 10.4 | — |
| PRIMARY SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 |
5.8; 2.6; 5.0; 8.8; 7.2; 4.8 | — |
| PRIMARY SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 |
1.3; 5.1; 6.0; 2.1; 0; 2.6 | — |
| PRIMARY SSD: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 |
2.6; 0.6; 1.3; 0.6; 0; 22.7 | — |
| PRIMARY SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Last Study Vaccination: Cohort 1 |
3.2; 6.1; 2.0 | — |
| PRIMARY SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Vaccination 1: Cohort 2 |
4.1; 3.7 | — |
| PRIMARY SSD: Percentage of Participants Reporting Adverse Events (AEs) From Second Study Vaccination Through 1 Month After Second Study Vaccination: Cohort 2 |
2.3; 3.8 | — |
| PRIMARY SSD: Percentage of Participants Reporting Adverse Events (AEs) From First Study Vaccination (Day 1) Through 1 Month After Second Study Vaccination: Cohort 3 |
6.7 | — |
| PRIMARY SSD: Percentage of Participants Reporting Adverse Events (AEs) From Third Study Vaccination Through 1 Month After Third Study Vaccination: Cohort 3 |
0.6 | — |
| PRIMARY SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination (Day 1) Through 6 Months After Last Study Vaccination: Cohort 1 and Cohort 3 |
0.9; 1.5; 1.0; 3.8 | — |
| PRIMARY SSD: Percentage of Participants Reporting SAEs From First Study Vaccination (Day 1) Through 6 Months After Vaccination 1 (For Participants Who Received 1 Dose Only) and up to Vaccination 2 (For Participants Who Received 2 Doses): Cohort 2 |
1.6; 0.6 | — |
| PRIMARY SSD: Percentage of Participants Reporting Serious Adverse Events (SAEs) From First Study Vaccination Through 6 Months After Vaccination 2: Cohort 2 |
0.5; 1.3 | — |
| PRIMARY SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 |
1929.2; 1099.6 | — |
| PRIMARY SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 2 Group 3 and Group 4 |
62.3; 39.3 | — |
| PRIMARY SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b |
5094.1; 1775.6 | — |
| PRIMARY SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers: Comparison Between 1 Month After Second Study Vaccination for Cohort 1 Group 2 and 1 Month After First Study Vaccination for Cohort 1 Group 2b |
4684.3; 1775.6 | — |
| PRIMARY Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After First Study Vaccination: Comparison Between Cohort 1 Group 1 and Group 2b |
88.0; 59.0 | — |
| PRIMARY SSD: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Vaccination 2: Comparison Between 1 Month After Vaccination 2 for Cohort 1 Group 2 and 1 Month After Vaccination 1 for Cohort 1 Group 2b |
80.0; 59.0 | — |
| PRIMARY SSD: GMR Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Second Study Vaccination: Cohort 3 |
2892.2; 290.6 | — |
| PRIMARY SSD: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Second Study Vaccination: Cohort 3 |
86.2; 80.8 | — |
| PRIMARY SSE: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination |
6.7; 0; 6.7; 8.1; 6.3; 10.9 | — |
| PRIMARY SSE: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination |
13.3; 0; 10.0; 10.0; 10.8; 19.4 | — |
| PRIMARY SSE: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination |
13.3; 6.7; 13.3; 7.7; 6.3; 9.3 | — |
| PRIMARY SSE: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Month After Study Vaccination |
0; 0; 0; 0.6; 1.3; 0.9 | — |
| PRIMARY SSE: Percentage of Participants With Elevated Troponin I Levels Before the Study Vaccination- 18 to 55 Years of Age |
0; 0; 0 | — |
| PRIMARY SSE: Percentage of Participants With Elevated Troponin I Levels 3 Days After Study Vaccination- 18 to 55 Years of Age |
0; 0; 0 | — |
| PRIMARY SSE: Geometric Mean Ratio (GMR) Based on Geometric Mean Titers of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers 1 Month After Study Vaccination |
455.8; 1014.5; 1435.2; 711.0; 900.1 | — |
| PRIMARY SSE: Percentage of Participants With Seroresponse to the SARS-CoV-2 Omicron BA.1 Strain at 1 Month After Study Vaccination |
57.0; 76.7; 86.1; 71.6; 67.9 | — |
| PRIMARY SSF: Geometric Mean Titer (GMTs) of SARS-CoV-2 Omicron BA.1 Strain Neutralizing Titers Before Vaccination |
41.7; 33.2; 32.0; 36.8; 78.8; 21.5 | — |
| PRIMARY SSF: Percentage of Participants With Local Reactions Within 7 Days After Study Vaccination |
19.0; 21.1; 23.8; 20.0; 10.0; 28.6 | — |
| PRIMARY SSF: Percentage of Participants With Systemic Events Within 7 Days After Study Vaccination |
9.5; 10.5; 9.5; 10.0; 5.0; 4.8 | — |
| PRIMARY SSF: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Study Vaccination |
0; 10.5; 9.5; 5.0; 10.0; 0 | — |
| PRIMARY SSF: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 6 Months After Study Vaccination |
0; 5.3; 4.8; 0; 5.0; 0 | — |
| PRIMARY SSF: GMTs of SARS-CoV-2 Reference-Strain-Neutralizing Titers Before Vaccination |
541.1; 382.4; 437.5; 315.2; 803.4; 256.0 | — |
| PRIMARY SSF: GMTs of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers Before Vaccination |
27.1; 18.0; 20.2; 23.4; 42.2; 15.0 | — |
| PRIMARY SSF: Geometric Mean Ratio (GMR) Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Day 7 |
146.1; 101.6; 217.1; 315.2; 337.8; 222.9 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Day 7 |
1917.2; 1241.4; 1472.3; 1499.2; 2702.4; 1845.8 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain Neutralizing Titers at Day 7 |
75.5; 56.6; 73.0; 76.1; 123.6; 70.7 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 1 |
420.0; 188.1; 699.4; 675.6; 1024.0; 477.7 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 1 |
4674.1; 2048.4; 3327.0; 3565.8; 5404.7; 2521.4 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1 |
157.6; 85.7; 151.0; 230.7; 284.0; 147.0 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 3 |
247.3; 118.5; 461.4; 711.0; 512.0; 285.6 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 3 |
2896.3; 1290.2; 2610.3; 2949.6; 2610.3; 1474.8 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3 |
222.9; 132.8; 322.5; 458.9; 296.2; 141.3 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers at Month 6 |
239.6; 229.5; 1058.4; 1722.2; 588.1; 284.0 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Reference-Strain-Neutralizing Titers at Month 6 |
1424.5; 1371.0; 2756.4; 3956.5; 2702.4; 1097.5 | — |
| PRIMARY SSF: GMR Based on GMT of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6 |
203.2; 265.5; 645.1; 1305.2; 430.5; 187.4 | — |
| PRIMARY SSF: Geometric Mean Fold-Rise (GMFR) of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination |
3.5; 2.9; 6.8; 8.6; 4.3; 9.8 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination |
3.5; 3.1; 3.4; 4.8; 3.4; 6.3 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 7 Days After Vaccination |
2.8; 2.8; 3.6; 3.2; 2.9; 4.7 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination |
10.1; 5.4; 20.4; 18.4; 13.0; 21.1 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination |
8.6; 5.0; 7.2; 11.3; 6.7; 8.6 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 1 Month After Vaccination |
5.9; 4.7; 7.5; 9.8; 6.7; 9.5 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination |
5.9; 3.3; 13.5; 17.9; 6.5; 12.0 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination |
5.0; 3.2; 5.6; 8.6; 3.2; 4.5 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 3 Months After Vaccination |
8.6; 7.4; 16.0; 18.5; 7.2; 9.4 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.1 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination |
5.8; 6.9; 33.1; 46.9; 7.5; 12.6 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination |
2.6; 3.6; 6.3; 12.6; 3.4; 3.9 | — |
| PRIMARY SSF: GMFR of SARS-CoV-2 Omicron BA.4/BA.5 Strain-Neutralizing Titers From Before the Study Vaccination to 6 Months After Vaccination |
7.5; 16.6; 32.0; 55.7; 10.2; 13.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Day 7 |
52.4; 44.4; 71.4; 85.0; 55.0; 90.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Day 7 |
52.4; 55.6; 61.9; 80.0; 55.0; 80.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Day 7 |
33.3; 43.8; 42.9; 40.0; 40.0; 61.9 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 1 |
85.7; 61.1; 90.0; 85.0; 90.0; 85.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 1 |
81.0; 61.1; 85.0; 85.0; 70.0; 75.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 1 |
75.0; 61.1; 66.7; 95.0; 80.0; 85.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 3 |
65.0; 50.0; 75.0; 84.2; 70.0; 89.5 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 3 |
65.0; 55.6; 65.0; 78.9; 55.0; 63.2 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 3 |
75.0; 61.1; 85.7; 84.2; 63.2; 85.7 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.1 Strain-Neutralizing Titers at Month 6 |
42.9; 47.4; 85.7; 90.0; 65.0; 85.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to the Reference-Strain-Neutralizing Titers at Month 6 |
42.9; 42.1; 61.9; 85.0; 55.0; 50.0 | — |
| PRIMARY SSF: Percentage of Participants With Seroresponse to Omicron BA.4/BA.5 Strain-Neutralizing Titers at Month 6 |
52.4; 50.0; 85.7; 90.0; 70.0; 75.0 | — |
| SECONDARY SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population |
0; 2.103 | — |
| SECONDARY SSA: Occurrence of First Severe COVID-19 Infection (FDA Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection: Evaluable Efficacy Population |
0; 1.978 | — |
| SECONDARY SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection |
0; 0 | — |
| SECONDARY SSA: Occurrence of First Severe COVID-19 Infection (CDC Definition) Per 1000 Person-Years of Blinded Follow-up With and Without Evidence of Past SARS-CoV-2 Infection |
0; 0 | — |
| SECONDARY SSC: GMTs of SARS-CoV-2 Reference-Strain Neutralizing Titers at Baseline and 7 Days After the Booster Dose |
1846.7; 2230.4; 15193.4; 22689.7 | — |
| SECONDARY SSC: GMTs of SARS-CoV-2 Omicron BA.1- Neutralizing Titers at Baseline and 7 Days After the Booster Dose |
68.2; 131.1; 1356.4; 2655.7 | — |
| SECONDARY SSC: GMFRs of SARS-CoV-2 Reference-Strain-Neutralizing Titers From Baseline to 7 Days After the Booster Dose |
8.2; 10.2 | — |
| SECONDARY SSC: GMFRs of SARS-CoV-2 Omicron BA.1-Neutralizing Titers From Baseline to 7 Days After the Booster Dose |
19.7; 20.2 | — |
| SECONDARY SSC: Percentages of Participants With Seroresponse to Reference Strain at 7 Days After the Booster Dose |
71.2; 68.1 | — |
| SECONDARY SSC: Percentages of Participants With Seroresponse to Omicron BA.1 at 7 Days After the Booster Dose |
77.6; 74.5 | — |
| SECONDARY SSE: GMR Based on Geometric Mean Titers of SARS-CoV-2 Reference Strain Neutralizing Titers at 1 Month After the Study Vaccination- >55 Years of Age |
5998.1; 5933.2; 7816.9 | — |
Summary
Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19
* At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
* In healthy adults 16 years of age and older
* The duration of the study for each participant will be up to approximately 12 months.
* The study will be conducted in the United States, Brazil and South Africa
Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have received 2 or 3 prior doses of BNT162b2 (30-µg doses) with their last dose at least 4 months (120 days) prior to randomization.
* Blood samples will be collected for troponin testing
* The duration of the study for each participant will be up to approximately 2 months.
* The study will be conducted in the United States, Germany, Poland and South Africa
Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months (150 days) prior to randomization.
* In healthy adults 12 years of age and older
* The duration of the study for each participant will be up to approximately 12 months.
* The study will be conducted in the United States, Germany and South Africa
Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third, fourth or fifth) dose
* Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrolment
* Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization
* Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a dose of BNT162b2 approximately 5 months (150 days) later. If participants do not consent to receive BNT162b2 as a third dose, they will not receive a third dose. No participants should receive BNT162b2 OMI as a third dose.
* In healthy adults 18 to 55 years of age
* The duration of the study for each participant will be up to approximately 12 months.
* The study will be conducted in the United States and South Africa
Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose
* In healthy adults 18 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization
* The duration of the study for each participant will be approximately 6 months.
* The study will be conducted in the United States
Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose.
* In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization
* The duration of the study for each participant will be approximately 6 months.
* The study will be conducted in Israel
Eligibility Criteria
Substudy A
Inclusion Criteria
- Male or female participants ≥16 years of age at Visit 1 (Day 1) who participated in C4591001.
- Participants who are willing and able to comply with all scheduled visits, vaccination 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 signed informed consent.
- Participants who have received 2 prior doses of 30 µg BNT162b2 19-42 days apart, with the second dose being at least 175 days before Visit 1 (Day 1).
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.
- 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.
- 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, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before study intervention administration, or planned receipt throughout the study.
- Prior receipt of any COVID-19 vaccine other than BNT162b2.
- 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.
- Receipt of medications intended to prevent COVID-19.
- Prior receipt of more than 2 doses of BNT162b2 30 µg.
- Participation in other studies involving study intervention within 28 days prior to study entry, other than C4591001, and/or within 28 days of confirmed receipt of BNT162b2 within the study.
Substudy B
Inclusion Criteria
- Male or female participants 12 to 30 years of age, inclusive, who have received 2 prior doses of 30 µg BNT162b2 19 to 60 days apart, with the second dose being at least at least 4 months (120 days) before Visit 1 (Day 1)
- Participants who are willing and able to comply with all scheduled visits, vaccination 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 signed informed consent.
Exclusion Criteria
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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 microbi
Data sourced from ClinicalTrials.gov (NCT04955626). 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.