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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 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 629 participants.
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
Interventions
- BIOLOGICAL BNT162b2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 629 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2021-12-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04816669
The ClinicalTrials.gov registry entry for NCT04816669 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 629 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BNT162b2 is the first listed.
NCT04816669 reports 0 study locations.
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.
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