Purpose of this Study
This study is testing a COVID-19 vaccine called BNT162b2 to see if it is safe and works well against new variants. It will compare one dose of the vaccine to a placebo, which does nothing. The study is for healthy people ages 50 to 64 who are not at high risk for severe COVID-19. Some people will report side effects like soreness or fever using an online diary. A small group may give blood samples to check how the immune system responds. Everyone will have a nose swab at the first visit and if they get sick with COVID-19 during the study.
Who Can Participate?
Eligibility
People can join this study if they are between 50 and 64 years old on the first day of the study. They must be healthy, based on their medical history and a checkup. People with stable health problems can join as long as the problem does not make COVID-19 worse and has not needed big changes in treatment or a hospital stay in the past 6 weeks.
Age Range
50-64
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
This study is checking if a COVID-19 vaccine is safe, easy to handle, and helps the body fight the virus. It is for adults between 50 and 64 years old who do not have health problems that make COVID-19 worse.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full 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
Principal Investigator
Emmanuel
Walter
Protocol Number
PRO00119276
NCT ID
NCT07300839
Phase
III
Enrollment Status
Pending Open to Enrollment