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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
343
BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)
Stanford University Medical Center CTRU - 800 Welch Road
Palo Alto, California, United States
California Research Foundation
San Diego, California, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
C & R Research USA
Homestead, Florida, United States
Florida Pharmaceutical Research and Associates
Miami, Florida, United States
Percentage of participants reporting local reactions
Time frame: For up to 7 days after vaccination
Percentage of participants reporting systemic events
Time frame: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time frame: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Time frame: Through 6 months after vaccination
Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 1 month after vaccination
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Bio-Medical Research LLC
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, United States
Medical Research Partners
Ammon, Idaho, United States
AMR Clinical
Oak Brook, Illinois, United States
...and 19 more locations