Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07300839

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BNT162b2 Vaccine

Biological

Single dose

Placebo

Biological

Single dose

Primary outcomes

  1. Percentage of participants reporting local reactions or systemic events

    Time frame: From Day 1 up to 7 days after Vaccination

  2. Percentage of participants reporting adverse events

    Time frame: From Day 1 through 4 weeks after vaccination

  3. Percentage of participants reporting serious adverse events

    Time frame: From Day 1 through 6 months after vaccination

  4. First episode of confirmed COVID-19 cases

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

Secondary outcomes

  1. First episode of confirmed COVID-19 cases

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

  2. Geometric Mean Ratio (GMR)

    Time frame: From before vaccination to 1 month after vaccination

Sponsors and collaborators

Lead sponsor

BioNTech SE

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.