A Study of COVID‑19 Vaccine(s) in Children and Adults

Trial status:Will Be Recruiting
Trial ID:
C4591083
NCT ID:
NCT07798648
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Will Be Recruiting

Trial Details

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 1 injection into their arm of BNT162b2 vaccine 1 which targets COVID-19. 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 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.

Medical Condition
COVID-19
Study Drug
BNT162b2
Phase
Phase 3
Type
Interventional
Estimated Enrolment
700
Estimated Trial Date
Aug 2026 - Apr 2027

Trial Participant Requirements

Age
5+ years
Sex
Female & Male
Healthy Volunteers
Yes
Inclusion and Exclusion Criteria
Inclusion criteria
  • Participants 5 years of age or older.
  • Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.
Exclusion criteria
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • History of myocarditis or pericarditis.
  • Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment.

    • Refer to the study contact for further eligibility details.

Trial Locations

No locations found.