A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
Purpose
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.
Conditions
- COVID-19
- SARS-COV-2 Infection
Eligibility
- Eligible Ages
- Between 5 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
- Masking Description
- This is an open-label study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 5-11 Years (Higher-Risk Individuals) |
BNT162b2 (2025/2026 formulation) |
|
Recruiting Locations
California Research Foundation
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751 33012
Hialeah 4158476, Florida 4155751 33012
Clinical Neuroscience Solutions, Inc.
Orlando 4167147, Florida 4155751 32801
Orlando 4167147, Florida 4155751 32801
GCP Research, Global Clinical professionals
St. Petersburg 4171563, Florida 4155751 33705
St. Petersburg 4171563, Florida 4155751 33705
Dayton Clinical Research
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Senders Pediatrics
South Euclid 5172485, Ohio 5165418 44121
South Euclid 5172485, Ohio 5165418 44121
Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040 29405
North Charleston 4589387, South Carolina 4597040 29405
DM Clinical Research- Cyfair
Houston 4699066, Texas 4736286 77065
Houston 4699066, Texas 4736286 77065
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030 84109
Salt Lake City 5780993, Utah 5549030 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City 5780993, Utah 5549030 84121
Salt Lake City 5780993, Utah 5549030 84121
Clinical Research Partners, LLC
Richmond 4781708, Virginia 6254928 23226
Richmond 4781708, Virginia 6254928 23226
More Details
- NCT ID
- NCT07222384
- Status
- Recruiting
- Sponsor
- BioNTech SE