NCT07300839

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,240 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• COVID-19
• SARS-COV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 Vaccine	Single dose
BIOLOGICAL	Placebo	Single dose

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-12-24
• Last updated: 2026-04-13

Locations

196 sites across 1 country: United States

Regulatory

• FDA-regulated drug study