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NCT05472038 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
A Phase 2 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,453
- Enrollment target
NCT05472038 is a Phase 2 study that has completed, run by BioNTech SE. The registered enrollment target is 1,453 participants.
The verdict
NCT05472038, a Phase 2 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,453 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19. For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries. For Cohort 1, this study included participants who were: * 18 through 55 years of age * have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study. All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1). For Cohort 2, this study included participants who were: * 12 years of age and older * have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose. For Cohort 3, this study included participants who were: * 18 years of age and older * have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study. * Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms. For Cohort 4, this study is seeking participants who are: * 18 through 55 years of age * have received 3
Interventions
- BIOLOGICAL BNT162b5 Bivalent (WT/OMI BA.2)
- BIOLOGICAL BNT162b2 Bivalent (WT/OMI BA.1)
- BIOLOGICAL BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
- BIOLOGICAL BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
- BIOLOGICAL BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,453 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2024-03-26 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05472038
The ClinicalTrials.gov registry entry for NCT05472038 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,453 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 5 interventions - of which BNT162b5 Bivalent (WT/OMI BA.2) is the first listed.
NCT05472038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05472038 about?
NCT05472038 is a clinical study titled "A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals". The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19. For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting d...
What is the current status of trial NCT05472038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,453 participants. The study started on 2022-07-26. Estimated completion is 2024-03-26.
What interventions are being tested in trial NCT05472038?
The interventions under investigation include: BNT162b5 Bivalent (WT/OMI BA.2) (BIOLOGICAL), BNT162b2 Bivalent (WT/OMI BA.1) (BIOLOGICAL), BNT162b2 Bivalent (WT/OMI BA.4/BA.5) (BIOLOGICAL), BNT162b5 Bivalent (Original/OMI BA.4/BA.5) (BIOLOGICAL), BNT162b6 Bivalent (Original/OMI BA.4/BA.5) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05472038?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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