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
Brief Summary

The purpose of this study is to learn about the safety, tolerability, and immunogenicityof an updated vaccine against COVID-19.This study is seeking participants 18 through 64 years of age who are considered to be athigher risk for severe COVID-19 disease per study protocol and those 65 years of age andolder. All participants in this study will receive 1 shot to their arm of a BNT162b2 (OmiLP.8.1) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and isselected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6months for each participant, and participants will need to visit the clinical study siteat least 4 times.

Detailed Description

Not Provided

Not yet recruiting
COVID-19
SARS-CoV-2 Infection

Biological: BNT162b2 (Omi LP.8.1)

BNT162b2 monovalent (Omicron LP.8.1)

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

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

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

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

Accellacare - Wilmington
Wilmington, North Carolina, United States

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

Contacts

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

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
MeSH Terms
COVID-19