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COVID-19 VaccinesChildren's healthLungs and breathingBiologicalPhase 3

What this study is

The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.

This study is seeking participants who:

  • are medically stable
  • have not had a recent COVID-19 infection or a recent COVID-19 vaccination
  • have not received certain routine vaccines recently
  • participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19.

Participants in Cohort 1 of this study will receive a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. The study team and participants will know which injection they receive.

Participants in Cohort 2 of this study will randomly receive 1 injection into their upper arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.

Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.

What's being tested

  • BNT162b2

    Intervention · BIOLOGICAL

    BNT162b2 vaccine 1 (2026/2027 recommended strain)

  • BNT162b2

    Intervention · BIOLOGICAL

    BNT162b2 vaccine 2

  • BNT162b2

    Intervention · BIOLOGICAL

    BNT162b2 vaccine 3

Study details

Official title
A PHASE 3 CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN CHILDREN AND ADULTS
Sponsor
BioNTech SE
Conditions
COVID-19 Vaccines
Enrolling
700 people
Starts
2026-08-31
Est. completion
2027-04-21
Design
Triple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗