Summary

Eligibility
for people ages 50-64 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
study ends around

Description

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).

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

Details

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.

Keywords

COVID-19, SARS-COV-2 Infection, BNT162 Vaccine, BNT162b2 Vaccine

Eligibility

You can join if…

Open to people ages 50-64

  • 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.

You CAN'T join if...

  • 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

  • UCSD AntiViral Research Center (AVRC) not yet accepting patients
    San Diego California 92103 United States
  • Artemis Institute for Clinical Research accepting new patients
    San Diego California 92103 United States
  • Eximia Research-CA, LLC not yet accepting patients
    La Mesa California 91942 United States
  • Velocity Clinical Research, Chula Vista not yet accepting patients
    Chula Vista California 91911 United States
  • Velocity Clinical Research, San Bernardino accepting new patients
    San Bernardino California 92408 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
BioNTech SE
ID
NCT07300839
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 25500 study participants
Last Updated