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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Trial sites expanded: 0 → 14 locations · Primary and study completion dates: Apr 20, 2027 to Apr 21, 2027 Show 2 more changesShow less
    • Trial sites expanded: 0 → 14 locations
    • Primary and study completion dates: Apr 20, 2027 to Apr 21, 2027
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BioNTech SE
49 trials monitored
See 3 trials at risk
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.
Trial Details
NCT Number NCT07798648
Lead Sponsor BioNTech SE
Collaborators: Pfizer
Conditions COVID-19 Vaccines
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov