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NCT05543616 · ClinicalTrials.gov registry record · Phase 2
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
A Phase 2 study of COVID-19 and SARS-CoV-2 Virus, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 4,292
- Enrollment target
- 20
- Study locations
NCT05543616 is a Phase 2 study of COVID-19 and SARS-CoV-2 Virus that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 4,292 participants, below the 55,193-participant average among 203 other COVID-19 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT05543616, a Phase 2 study of COVID-19 and SARS-CoV-2 Virus, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 4,292 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. * Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. * Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. * Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.
Conditions Studied
Interventions
- BIOLOGICAL Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
- BIOLOGICAL Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
- BIOLOGICAL Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- BIOLOGICAL Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
- BIOLOGICAL Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
Study Locations (20)
California
- Advanced Research Center Inc. - Anaheim
- Paradigm Clinical Research Centers, Inc - La Mesa
- Hoag Medical Group Foothill Ranch - Lake Forest
- Kaiser Permanente - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- Kaiser Permanente Oakland - Oakland
- Kaiser Permanente Oakland - Oakland
- Kaiser Permanente Oakland - Oakland
- Clinical and Translational Research Unit (CTRU) & Spectrum Biobank - Palo Alto
- Center for Clinical Trials, LLC - Paramount
- Peninsula Research Associates - Rolling Hills Estates
- Kaiser Permanente Sacramento - Sacramento
- Kaiser Permanente Sacramento - Sacramento
- Kaiser Permanente Sacramento - Sacramento
- Paradigm Clinical Research, LLC - San Diego
- Kaiser Permanente Santa Clara - Santa Clara
Alabama
- UAB Child Health Research Unit (CHRU) - Birmingham
- UAB Child Health Research Unit (CHRU) - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Northwest Arkansas Pediatric Clinic - Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,292 participants |
| Start Date | 2022-09-23 |
| Est. Completion | 2026-06-16 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05543616
The ClinicalTrials.gov registry entry for NCT05543616 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 4,292 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,193-participant average among 203 other COVID-19 trials with a reported enrollment target (92% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose is the first listed.
NCT05543616 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05543616 about?
NCT05543616 is a clinical study titled "A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children". The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior hi...
What is the current status of trial NCT05543616?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 4,292 participants. The study started on 2022-09-23. Estimated completion is 2026-06-16.
What conditions does trial NCT05543616 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2.
What interventions are being tested in trial NCT05543616?
The interventions under investigation include: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose (BIOLOGICAL), Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose (BIOLOGICAL), Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose (BIOLOGICAL), Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose (BIOLOGICAL), Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT05543616?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05543616 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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