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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: Recruiting Phase 2 study of COVID-19 and SARS-CoV-2 Virus, sponsored by BioNTech SE.

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 38,451-participant average among 298 other COVID-19 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

Conditions Studied

COVID-19 SARS-CoV-2 Virus Severe Acute Respiratory Syndrome Coronavirus 2

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

FieldValue
Enrollment Target 4,292 participants
Start Date 2022-09-23
Est. Completion 2026-06-16
Phase Phase 2
BioNTech SE

53 total trials

What NCT05543616 shows while recruiting

NCT05543616 is an interventional study that assigns participants to a tested intervention. Its 4,292 participants enrollment target places it among the larger protocols in the corpus, below the 38,451-participant average among 298 other COVID-19 trials with a reported enrollment target (89% lower).

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 names 20 study sites across 4 states, led by 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.

Learn More About Clinical Trials

Similar trials for COVID-19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05543616's enrollment target sits among peer trials

4,292 32nd of 298 higher than 267 of 298 other COVID-19 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other COVID-19 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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More recruiting context for NCT05543616

Source: ClinicalTrials.gov NCT05543616, the US trial registry maintained by the National Library of Medicine. NCT05543616 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.