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

NCT07798648 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-09-01

No results posted yet for this study

Summary

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.

Conditions

  • COVID-19 Vaccines

Interventions

BIOLOGICAL

BNT162b2

BNT162b2 vaccine 1

BIOLOGICAL

BNT162b2

BNT162b2 vaccine 2

BIOLOGICAL

BNT162b2

BNT162b2 vaccine 3

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-04-20
Completion
2027-04-20
FDA Drug
Yes

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07798648 on ClinicalTrials.gov