COVID-19, SARS-COV-2 Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALBNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Sponsors
BioNTech SE
Pfizer
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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.
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 |
| Cohort 1: Geometric Mean Titers (GMTs) | At 2 weeks after vaccination |
| Cohort 1: Geometric Mean Fold Rises (GMFRs) | From before vaccination to 2 weeks after vaccination |
| Cohort 1: Percentages of participants with seroresponse | 2 weeks after vaccination |
| Cohort 2: Geometric Mean Fold Rises (GMFRs) | From before vaccination to 1 month after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Geometric Mean Titers (GMTs) | At 1 month after vaccination |
| Cohort 1: Geometric Mean Fold Rises (GMFRs) | From before vaccination to 1 month after vaccination |
| Cohort 1: Percentages of participants with seroresponse | 1 month after vaccination |
| Cohort 2: Geometric Mean Titers (GMTs) | From before vaccination to 1 month after vaccination |
| Cohort 2: Percentages of participants with seroresponse | 1 month after vaccination |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed