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
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of 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 their arm 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 the clinical study site at least 2 times.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 11
Healthy Volunteers: t
View:
• 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.
Locations
United States
California
California Research Foundation
RECRUITING
San Diego
Connecticut
Stamford Therapeutics Consortium
NOT_YET_RECRUITING
Stamford
Florida
Indago Research & Health Center, Inc
RECRUITING
Hialeah
C & R Research USA
NOT_YET_RECRUITING
Homestead
Bio-Medical Research LLC
NOT_YET_RECRUITING
Miami
Florida Pharmaceutical Research and Associates
NOT_YET_RECRUITING
Miami
Clinical Neuroscience Solutions, Inc.
RECRUITING
Orlando
GCP Research, Global Clinical professionals
RECRUITING
St. Petersburg
Illinois
AMR Clinical
NOT_YET_RECRUITING
Oak Brook
Kentucky
Kentucky Pediatric/ Adult Research
NOT_YET_RECRUITING
Bardstown
Minnesota
Clinical Research Institute
NOT_YET_RECRUITING
Minneapolis
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Dayton Clinical Research
RECRUITING
Dayton
Senders Pediatrics
RECRUITING
South Euclid
South Carolina
Coastal Carolina Research Center
RECRUITING
North Charleston
Texas
Cedar Health Research
NOT_YET_RECRUITING
Dallas
Proactive Clinical Research LLC
NOT_YET_RECRUITING
Edinburg
Headlands Research-El Paso
NOT_YET_RECRUITING
El Paso
DM Clinical Research- Cyfair
RECRUITING
Houston
ACRC Trials
NOT_YET_RECRUITING
Plano
Utah
AMR Clinical
NOT_YET_RECRUITING
Layton
J. Lewis Research, Inc. / Foothill Family Clinic
RECRUITING
Salt Lake City
J. Lewis Research, Inc. / Foothill Family Clinic South
RECRUITING
Salt Lake City
Virginia
Pediatric Research of Charlottesville, LLC
NOT_YET_RECRUITING
Charlottesville
Clinical Research Partners, LLC
RECRUITING
Richmond
Tekton Research, LLC.
NOT_YET_RECRUITING
Richmond
Other Locations
Puerto Rico
Clinical Research Puerto Rico
NOT_YET_RECRUITING
Guayama
Ponce Medical School Foundation Inc.
NOT_YET_RECRUITING
Ponce
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2025-10-30
Estimated Completion Date:2026-10-30
Participants
Target number of participants:330
Treatments
Experimental: 5-11 Years (Higher-Risk Individuals)