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

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.

Conditions

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

COVID-19SARS-COV-2 Infection

Study Overview

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Study Details

Study overview

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.

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

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

Condition
COVID-19
Intervention / Treatment

-

Contacts and Locations

Walnut Creek

Diablo Clinical Research, Inc., Walnut Creek, California, United States, 94598

Hialeah

Indago Research & Health Center, Inc, Hialeah, Florida, United States, 33012

Springfield

Bio-Kinetic Clinical Applications, LLC dba QPS-MO, Springfield, Missouri, United States, 65802

Springfield

Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center, Springfield, Missouri, United States, 65807

Wilmington

Accellacare - Wilmington, Wilmington, North Carolina, United States, 28401

Salt Lake City

J. Lewis Research, Inc. / Foothill Family Clinic, Salt Lake City, Utah, United States, 84109

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants 18 years of age or older.
  • * 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.
  • * 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:
  • * Asthma
  • * Diabetes mellitus type I
  • * Diabetes mellitus type II
  • * Heart conditions (eg. previous coronary artery disease or heart failure but excluding cardiomyopathy, myocarditis and pericarditis)
  • * HIV
  • * Mental health conditions limited to mood disorders, including depression.
  • * Parkinson disease
  • * Obesity (BMI ≥30)
  • * Smoking, current or former The medical conditions mentioned above must have remained stable for at least 6 weeks prior to enrollment.
  • * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • * History of myocarditis or pericarditis.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

BioNTech SE,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2026-01-06