COVID-19, SARS-COV-2 Infection
Conditions
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
Brief 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.
Interventions
BIOLOGICALBNT162b2 (2025/2026 formulation)
BNT162b2 (formulation targeting the 2025/2026 recommended SARS-CoV-2 strain)
Sponsors
BioNTech SE
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study.
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants reporting local reactions | For up to 7 days after vaccination |
| Percentage of participants reporting systemic events | For up to 7 days after vaccination |
| Percentage of participants reporting adverse events | Through 1 month after vaccination |
| Percentage of participants reporting serious adverse events | Through 6 months after vaccination |
| Geometric Mean Fold Rises (GMFRs) | From before vaccination to 1 month after vaccination |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed