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

BioNTech

Status and phase: Enrolling; Phase 3

Conditions: COVID-19; SARS-COV-2 Infection

Treatments: Biological: Placebo; Biological: BNT162b2 Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07300839

C4591081

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25,500 estimated patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25,500 participants in 2 patient groups, including a placebo group

BNT162b2 Vaccine

Experimental group

Treatment:

Biological: BNT162b2 Vaccine

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo