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
Status and phase
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Details and patient eligibility
About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
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Participants 18 years of age or older.
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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.
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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 design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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