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NCT04955626 · ClinicalTrials.gov registry record · Phase 3
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
A Phase 3 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 3
- Development phase
- 16,372
- Enrollment target
NCT04955626: Completed Phase 3 study, sponsored by BioNTech SE.
NCT04955626 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 16,372 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2023% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04955626, a Phase 3 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16,372 participants
- Enrollment target
Study 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
Primary Outcome
Occurrences (number of cases) of first COVID-19 infection in participants after booster dose per 1000 person-year, without past SARS-CoV-2 infection at interim analysis were reported in this outcome measure.
Interventions
- OTHER Placebo
- BIOLOGICAL BNT162b2
- BIOLOGICAL BNT162b2 OMI
- BIOLOGICAL Combination BNT162b2 and BNT162b2 OMI
- BIOLOGICAL Combination (Bivalent) BNT162b2 and BNT162b2 OMI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,372 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2023-05-25 |
| Phase | Phase 3 |
What the finished NCT04955626 record still lists
NCT04955626 is an interventional study that assigns participants to a tested intervention. Its 16,372 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2023% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04955626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04955626 about?
NCT04955626 is a clinical study titled "To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.". 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...
What is the current status of trial NCT04955626?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16,372 participants. The study started on 2021-07-01. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT04955626?
The interventions under investigation include: Placebo (OTHER), BNT162b2 (BIOLOGICAL), BNT162b2 OMI (BIOLOGICAL), Combination BNT162b2 and BNT162b2 OMI (BIOLOGICAL), Combination (Bivalent) BNT162b2 and BNT162b2 OMI (BIOLOGICAL).
Who is sponsoring clinical trial NCT04955626?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04955626's enrollment target sits among peer trials
16,372 12th of 2000 higher than 1,989 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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