Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07222384

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Puerto Rico, Guayama, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BNT162b2 (2025/2026 formulation)

Biological

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

Primary outcomes

  1. Percentage of participants reporting local reactions

    Time frame: For up to 7 days after vaccination

  2. Percentage of participants reporting systemic events

    Time frame: For up to 7 days after vaccination

  3. Percentage of participants reporting adverse events

    Time frame: Through 1 month after vaccination

  4. Percentage of participants reporting serious adverse events

    Time frame: Through 6 months after vaccination

  5. Geometric Mean Fold Rises (GMFRs)

    Time frame: From before vaccination to 1 month after vaccination

Sponsors and collaborators

Lead sponsor

BioNTech SE

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.