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NCT Number: NCT07798648

A Study of COVID-19 Vaccine(s) in Children and Adults

The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.

This study is seeking participants who:

* are medically stable * have not had a recent COVID-19 infection or a recent COVID-19 vaccination * have not received certain routine vaccines recently * participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19.

Participants in Cohort 1 of this study will receive 1 injection into their arm of BNT162b2 vaccine 1 which targets COVID-19. The study team and participants will know which injection they receive.

Participants in Cohort 2 of this study will randomly receive 1 injection into their arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.

Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.

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Key information

Conditions

COVID-19 Vaccines COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion criteria:

  • Participants 5 years of age or older.
  • Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.

Key Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • History of myocarditis or pericarditis.
  • Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment.

Refer to the study contact for further eligibility details.

Treatment and study plan

BNT162b2

Biological

BNT162b2 vaccine 1

Primary outcomes

  1. Percentage of participants reporting local reactions or systemic events

    Time frame: For up to 7 days after vaccination

  2. Percentage of participants reporting adverse events

    Time frame: Through 1 month after vaccination

  3. Percentage of participants reporting serious adverse events

    Time frame: Through 6 months after vaccination

  4. Geometric Mean Fold Rise (GMFRs)

    Time frame: From baseline to 1 month after vaccination

Secondary outcomes

  1. Geometric Mean Titers (GMTs)

    Time frame: At baseline and at 1 month after vaccination

  2. Percentage of participants with seroresponse

    Time frame: At 1 month after vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

BioNTech SE

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A PHASE 3 CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN CHILDREN AND ADULTS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 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.

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