A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

NCT07300839
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
5,240
clinicaltrials.gov
Lead sponsor
BioNTech SE
clinicaltrials.gov
Start date
2025-12-10
clinicaltrials.gov
Number of sites
196
clinicaltrials.gov

Summary
This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect against COVID-19 (placebo).
clinicaltrials.gov
Short title
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
clinicaltrials.gov
Official title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY AND EFFICACY OF A VARIANT-ADAPTED BNT162B2 VACCINE IN HEALTHY PARTICIPANTS 50 THROUGH 64 YEARS OF AGE
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
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Completion date
2026-07-31
clinicaltrials.gov
First posted
2025-12-24
clinicaltrials.gov
Registry last updated
2026-04-13
clinicaltrials.gov
Primary completion date
2026-07-31
clinicaltrials.gov
Start date
2025-12-10
clinicaltrials.gov

Actual participants
5,240
clinicaltrials.gov
Participants
5,240
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
1
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Number of sites
196
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
BioNTech SE
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07300839
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07300839
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of participants reporting local reactions or systemic events

    Timeframe: From Day 1 up to 7 days after Vaccination

  2. Percentage of participants reporting adverse events

    Timeframe: From Day 1 through 4 weeks after vaccination

  3. Percentage of participants reporting serious adverse events

    Timeframe: From Day 1 through 6 months after vaccination

  4. First episode of confirmed COVID-19 cases

    Timeframe: From 0 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination

  1. First episode of confirmed COVID-19 cases

    Timeframe: From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination

  2. Geometric Mean Ratio (GMR)

    Timeframe: From before vaccination to 1 month after vaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
50 Years
Maximum age
64 Years
Healthy volunteers
Yes

Key Inclusion Criteria

  • People who are between 50 and 64 years old at their first appointment.
  • People who are healthy and, based on their medical history and a doctor's judgment, are considered suitable to join the study.

Key Exclusion Criteria

  • People who had COVID-19 in the past 3 months (90 days) before their first visit.
  • People who got a COVID-19 vaccine, either as part of a research study or an approved vaccine, in the last 3 months-or plans to get one during the study.
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group, LLCAnniston, United States
  • North Alabama Research CenterAthens, United States
  • Simon Williamson Clinic / Synexus Clinical Research US, Inc.Birmingham, United States
  • Accel Research Sites - Birmingham Clinical Research UnitBirmingham, United States
  • Cullman Clinical TrialsCullman, United States
  • AMR ClinicalDaphne, United States
  • Medical Affiliated Research CenterHuntsville, United States
  • AMR ClinicalMobile, United States
  • Chandler Clinical TrialsChandler, United States
  • Scottsdale Clinical TrialsScottsdale, United States
  • Epic Medical Research-Sun CitySun City, United States
  • Noble Clinical ResearchTucson, United States
  • Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, United States
  • Woodland International Research Group, LLCLittle Rock, United States
  • Anaheim Clinical Trials, LLCAnaheim, United States
  • Velocity Clinical Research, Chula VistaChula Vista, United States
  • West Coast ResearchDublin, United States
  • Triallogix Medical CorporationFullerton, United States
  • Upper Echelon MedicalFullerton, United States
  • Marvel Clinical ResearchHuntington Beach, United States
  • Eximia Research-CA, LLCLa Mesa, United States
  • Velocity Clinical Research, Los AngelesLos Angeles, United States
  • Leading Edge ResearchLos Angeles, United States
  • ImmuniMetModesto, United States
  • Carbon Health - North Hollywood - NoHo WestNorth Hollywood, United States

And 171 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)