Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: 18 through 64 years of age (higher-risk individuals)
Participants will receive BNT162b2 (Omi LP.8.1) 30 µg at Visit 1
  • Biological: BNT162b2 (Omi LP.8.1)
    BNT162b2 monovalent (Omicron LP.8.1)
Experimental
Group 2: 65 years of age and older
Participants will receive BNT162b2 (Omi LP.8.1) 30 µg at Visit 1
  • Biological: BNT162b2 (Omi LP.8.1)
    BNT162b2 monovalent (Omicron LP.8.1)

Recruiting Locations

More Details

NCT ID
NCT07069309
Status
Not yet recruiting
Sponsor
BioNTech SE

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.