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

Purpose

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).

Conditions

  • COVID-19
  • SARS-COV-2 Infection

Eligibility

Eligible Ages
Between 50 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BNT162b2 Vaccine
  • Biological: BNT162b2 Vaccine
    Single dose
Placebo Comparator
Placebo
  • Biological: Placebo
    Single dose

Recruiting Locations

More Details

NCT ID
NCT07300839
Status
Active, not recruiting
Sponsor
BioNTech SE

Detailed Description

The study is designed to evaluate if the COVID-19 vaccine reduces COVID-19 disease as compared to placebo given to healthy adults 50 to 64 years of age. Approximately 25,500 participants will be randomly chosen to get either one dose of COVID-19 vaccine or of a placebo.