Official Title
A PHASE 3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BNT162b2 (LP.8.1)-ADAPTED VACCINE IN CHILDREN 5 THROUGH 11 YEARS OF AGE CONSIDERED AT HIGH RISK FOR 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, called BNT162b2 (2025/2026 formulation).This study is seeking participants 5 through 11 years of age who: - have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19, - and are medically stable.All participants in this study will receive 1 vaccine dose given in the muscle of theirarm of a BNT162b2 (2025/2026 formulation) vaccine which targets the COVID-19 virus,specifically the strain selected for the 2025-2026 COVID-19 viral respiratory season.Participants will take part in this study for about 6 months and will need to visit theclinical study site at least 2 times.

Detailed Description

Not Provided

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

Biological: BNT162b2 (2025/2026 formulation)

BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)

Eligibility Criteria

Key Inclusion Criteria:

- Children 5 through 11 years of age at their first appointment.

- Children with at least 1 underlying stable medical condition that increases their
risk of severe COVID-19, as listed in the protocol.

Key Exclusion Criteria:

- Children who have had confirmed COVID-19 within the last 5 months (150 days).

- Children who have received a COVID-19 vaccine, either as part of a research study or
an approved vaccine, within the last 5 months (150 days).

- Children who have received a 2025-2026 seasonal COVID-19 vaccination.

- Children with a history of myocarditis or pericarditis.

- Children with a previous or current diagnosis of Multisystem Inflammatory Syndrome
in Children (MIS-C)

- Children with a medical condition wherein they would be considered for a second dose
of COVID-19 vaccine to protect against risk of severe COVID-19 based on standard of
care.

Refer to the study contact for further eligibility details.

Eligibility Gender
All
Eligibility Age
Minimum: 5 Years ~ Maximum: 11 Years
Countries
United States
Locations

C & R Research USA
Homestead 4159050, Florida 4155751, United States

Florida Pharmaceutical Research and Associates
Miami 4164138, Florida 4155751, United States

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030, United States

J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City 5780993, Utah 5549030, 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
Keywords
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Lung Diseases
Respiratory Tract Diseases
Covid-19
mRNA vaccines
Nucleic Acid-Based Vaccines
Vaccines
Biological Products
COVID-19 Vaccines
Viral Vaccines
Antigens
Biological Factors
BNT162 Vaccine
MeSH Terms
COVID-19
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Lung Diseases
Respiratory Tract Diseases
BNT162 Vaccine