A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
Purpose
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).
Conditions
- COVID-19
- SARS-COV-2 Infection
Eligibility
- Eligible Ages
- Between 50 Years and 64 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BNT162b2 Vaccine |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT07300839
- Status
- Active, not recruiting
- Sponsor
- BioNTech SE
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.