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
Trial status:Recruiting
Trial ID:
C4591076
NCT ID:
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Recruiting
Trial Details
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.
Medical Condition
Study Drug
Phase
Phase 3
Type
Interventional
Estimated Enrolment
100
Estimated Trial Date
Jul 2025 - Jan 2026
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
Yes
Inclusion and Exclusion Criteria
Inclusion 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.
Exclusion criteria
- 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.
Refer to the study contact for further eligibility details.
Trial Locations
Location
Status
Location
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Status
Recruiting
Location
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
Status
Recruiting
Location
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States, 65802
Status
Recruiting
Location
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, United States, 65807
Status
Recruiting
Location
Accellacare - Wilmington
Wilmington, North Carolina, United States, 28401
Status
Recruiting
Location
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
Status
Recruiting