ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of BNT162b2 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants 12 Through 64 Years of Age Considered at Higher Risk of Severe COVID-19, and Participants ≥65 Years of Age

Quick Facts

Study Start:2025-07-08
Study Completion:2026-05-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07069309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cohort 1: Participants 18 years of age or older.
  2. * Cohort 2: Participants 12 years of age or older.
  3. * Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19.
  1. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  2. * History of myocarditis or pericarditis.
  3. * Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 5 months (150 days) prior to study enrollment.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
Clinical Research Consulting
Milford, Connecticut, 06460
United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, 20037
United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814
United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802
United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, 65807
United States
Rochester Clinical Research, LLC
Rochester, New York, 14609
United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401
United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212
United States
Senders Pediatrics
South Euclid, Ohio, 44121
United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
DM Clinical Research- Cyfair
Houston, Texas, 77065
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911
United States

Collaborators and Investigators

Sponsor: BioNTech SE

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-08
Study Completion Date2026-05-05

Study Record Updates

Study Start Date2025-07-08
Study Completion Date2026-05-05

Terms related to this study

Additional Relevant MeSH Terms

  • COVID-19
  • SARS-COV-2 Infection