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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07300839

Enrollment

5240

Registered

2025-12-24

Start date

2025-12-10

Completion date

2026-07-31

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-COV-2 Infection

Brief 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).

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.

Interventions

BIOLOGICALBNT162b2 Vaccine

Single dose

BIOLOGICALPlacebo

Single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 64 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Percentage of participants reporting local reactions or systemic events	From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events	From Day 1 through 4 weeks after vaccination
Percentage of participants reporting serious adverse events	From Day 1 through 6 months after vaccination
First episode of confirmed COVID-19 cases	From 0 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination

Secondary

Measure	Time frame
First episode of confirmed COVID-19 cases	From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination
Geometric Mean Ratio (GMR)	From before vaccination to 1 month after vaccination

Countries

United States

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026