RECRUITING

A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19

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 18 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 (Omi LP.8.1) 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, and participants will need to visit the clinical study site at least 4 times.

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 Adults, Including Those at Higher Risk of Severe COVID-19

Quick Facts

Study Start:2025-07-08
Study Completion:2026-01-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status: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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants 18 years of age or older.
  2. * Participants who have received a COVID-19 vaccine containing Omicron KP.2 \>6 months (\>175 days) prior to enrollment in the study and have not received any other COVID-19 vaccine or had physician-confirmed COVID-19 disease since this vaccination through to enrollment in the study.
  3. * Participants 18 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19. The following list of conditions have been developed utilizing conditions listed by the CDC and are deemed to increase the risk of developing severe COVID-19 disease in infected participants:
  4. * Asthma
  5. * Diabetes mellitus type I
  6. * Diabetes mellitus type II
  7. * Heart conditions (eg. previous coronary artery disease or heart failure but excluding cardiomyopathy, myocarditis and pericarditis)
  8. * HIV
  9. * Mental health conditions limited to mood disorders, including depression.
  10. * Parkinson disease
  11. * Obesity (BMI ≥30)
  12. * Smoking, current or former The medical conditions mentioned above must have remained stable for at least 6 weeks prior to enrollment.
  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.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
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
Accellacare - Wilmington
Wilmington, North Carolina, 28401
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
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 Date2026-01-06

Study Record Updates

Study Start Date2025-07-08
Study Completion Date2026-01-06

Terms related to this study

Additional Relevant MeSH Terms

  • COVID-19
  • SARS-COV-2 Infection