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NCT04816669 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
A Phase 3 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 3
- Development phase
- 629
- Enrollment target
NCT04816669: Completed Phase 3 study, sponsored by BioNTech SE.
NCT04816669 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 629 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04816669, a Phase 3 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 629 participants
- Enrollment target
Study Summary
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. * 2-dose schedule (separated by 21 days) * At a dose of 30µg (as studied in the Phase 2/3 study C4591001) * In healthy adults 18 through 55 years of age * The duration of the study for each participant will be approximately 2 months (3 visits in total) * The study will be conducted in the United States
Primary Outcome
GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was calculate
Interventions
- BIOLOGICAL BNT162b2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 629 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2021-12-02 |
| Phase | Phase 3 |
What the finished NCT04816669 record still lists
NCT04816669 is an interventional study that assigns participants to a tested intervention. The registered 629 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 1 intervention - of which BNT162b2 is the first listed.
NCT04816669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04816669 about?
NCT04816669 is a clinical study titled "A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults". This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-...
What is the current status of trial NCT04816669?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 629 participants. The study started on 2021-04-01. Estimated completion is 2021-12-02.
What interventions are being tested in trial NCT04816669?
The interventions under investigation include: BNT162b2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04816669?
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 NCT04816669's enrollment target sits among peer trials
629 584th of 2000 higher than 1,415 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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