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

BioNTech

Status and phase

Enrolling

Phase 3

Conditions

COVID-19 Vaccines

Treatments

Biological: BNT162b2

Study type

Interventional

Funder types

Industry

Identifiers

NCT07798648

C4591083

Details and patient eligibility

About

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 a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. 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 upper 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.

Enrollment

700 estimated patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

700 participants in 9 patient groups

Cohort 1 Group 1: 5-11 Years (with risk factors)

Experimental group

Description:

Participants will receive a single injection (age appropriate dose) on Day 1

Treatment:

Biological: BNT162b2

Cohort 1 Group 3: ≥65 Years

Experimental group

Description:

Participants will receive a single injection (age appropriate dose) on Day 1.

Treatment:

Biological: BNT162b2

Cohort 1 Group 2: 12-64 Years (with risk factors)

Experimental group

Description:

Participants will receive a single injection (age appropriate dose) on Day 1

Treatment:

Biological: BNT162b2

Cohort 2 Group 5: 18-64 Years (with risk factors)

Experimental group

Description: