MedTrace Logo

A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years

NCT07069309 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2025-12-22

No results posted yet for this study

Summary

The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.

This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.

Conditions

Interventions

BIOLOGICAL

BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)

BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2026-05-05
Completion
2026-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069309 on ClinicalTrials.gov