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

Phase 3Active Not RecruitingNCT07300839

BioNTech SE5,240 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

5,240

Conditions

COVID-19 SARS-COV-2 Infection

Interventions

BNT162b2 VaccineBIOLOGICAL

Single dose

PlaceboBIOLOGICAL

Single dose

Eligibility

Sex: ALLMin age: 50 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (196)

Outcomes

Primary Outcomes

Percentage of participants reporting local reactions or systemic events

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

Percentage of participants reporting adverse events

Time frame: From Day 1 through 4 weeks after vaccination

Percentage of participants reporting serious adverse events

Time frame: From Day 1 through 6 months after vaccination

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

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

Geometric Mean Ratio (GMR)

Time frame: From before vaccination to 1 month after vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pinnacle Research Group, LLC

Anniston, Alabama, United States

North Alabama Research Center

Athens, Alabama, United States

Simon Williamson Clinic / Synexus Clinical Research US, Inc.

Birmingham, Alabama, United States

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

AMR Clinical

Daphne, Alabama, United States

Medical Affiliated Research Center

Huntsville, Alabama, United States

AMR Clinical

Mobile, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

...and 186 more locations