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OpenTrials
Completed

NCT Number: NCT07069309

A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years

The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.

This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.

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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

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Diablo Clinical Research, Inc., Walnut Creek, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cohort 1: Participants 18 years of age or older.
  • Cohort 2: Participants 12 years of age or older.
  • Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19.

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.
  • Cohort 2: 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 5 months (150 days) prior to study enrollment.

Refer to the study contact for further eligibility details.

Treatment and study plan

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

Biological

BNT162b2 monovalent (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. Cohort 1: Geometric Mean Titers (GMTs)

    Time frame: At 2 weeks after vaccination

  6. Cohort 1: Geometric Mean Fold Rises (GMFRs)

    Time frame: From before vaccination to 2 weeks after vaccination

  7. Cohort 1: Percentages of participants with seroresponse

    Time frame: 2 weeks after vaccination

  8. Cohort 2: Geometric Mean Fold Rises (GMFRs)

    Time frame: From before vaccination to 1 month after vaccination

Secondary outcomes

  1. Cohort 1: Geometric Mean Titers (GMTs)

    Time frame: At 1 month after vaccination

  2. Cohort 1: Geometric Mean Fold Rises (GMFRs)

    Time frame: From before vaccination to 1 month after vaccination

  3. Cohort 1: Percentages of participants with seroresponse

    Time frame: 1 month after vaccination

  4. Cohort 2: Geometric Mean Titers (GMTs)

    Time frame: From before vaccination to 1 month after vaccination

  5. Cohort 2: Percentages of participants with seroresponse

    Time frame: 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 BNT162B2 RNA-BASED VARIANT-ADAPTED VACCINE CANDIDATE(S) AGAINST SARS-COV-2 IN PARTICIPANTS 12 THROUGH 64 YEARS OF AGE CONSIDERED AT HIGHER RISK OF SEVERE COVID-19, AND PARTICIPANTS ≥65 YEARS OF AGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jun 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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