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NCT05541861 · ClinicalTrials.gov registry record · Phase 1
Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
A Phase 1 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 1
- Development phase
- 383
- Enrollment target
NCT05541861: Completed Phase 1 study, sponsored by BioNTech SE.
NCT05541861 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 383 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (538% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05541861, a Phase 1 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 383 participants
- Enrollment target
Study Summary
This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 1 and Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b, and 30 microgram (mcg) BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5. The trial used a staggered dosing process schema, i.e., enrollment into the next higher dose level was done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged \>55 years was opened after safety data for participants aged 18-55 years in Cohort 3a had been reviewed. Enrollment into Cohorts 4a and 4b was opened after safety data for Cohort 3a and 3b had been reviewed. Cohort 5 participants were not randomized and received two doses of BNT162b4 alone after which a safety review was performed after all participants received Dose 2 in this cohort. BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) was co-administered (as a single injection). BNT162b4 alone was administered as a single injection.
Primary Outcome
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling.
Interventions
- BIOLOGICAL BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg
- BIOLOGICAL BNT162b4 5 mcg
- BIOLOGICAL BNT162b4 10 mcg
- BIOLOGICAL BNT162b4 15 mcg
- BIOLOGICAL BNT162b4 30 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2024-11-22 |
| Phase | Phase 1 |
What the finished NCT05541861 record still lists
NCT05541861 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (538% higher).
The record links to 0 conditions, and to 5 interventions - of which BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg is the first listed.
NCT05541861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05541861 about?
NCT05541861 is a clinical study titled "Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People". This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivale...
What is the current status of trial NCT05541861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 383 participants. The study started on 2022-11-08. Estimated completion is 2024-11-22.
What interventions are being tested in trial NCT05541861?
The interventions under investigation include: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg (BIOLOGICAL), BNT162b4 5 mcg (BIOLOGICAL), BNT162b4 10 mcg (BIOLOGICAL), BNT162b4 15 mcg (BIOLOGICAL), BNT162b4 30 mcg (BIOLOGICAL).
Who is sponsoring clinical trial NCT05541861?
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 NCT05541861's enrollment target sits among peer trials
383 81st of 2000 higher than 1,920 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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