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

Conditions

• COVID-19 Vaccines

Eligibility Criteria

Sex

ALL

Age

5 Years - N/A

Healthy Volunteers

Accepted

Interventions

• BNT162b2 — BIOLOGICAL
  BNT162b2 vaccine 1 (2026/2027 recommended strain)
• BNT162b2 — BIOLOGICAL
  BNT162b2 vaccine 2
• BNT162b2 — BIOLOGICAL
  BNT162b2 vaccine 3

Study Details

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.

Key Dates

First listed

Sep 1, 2026

Start date

Aug 31, 2026

Status verified

Sep 2026

Primary completion

Apr 21, 2027

Completion

Apr 21, 2027

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Cohort 1 Group 1: 5-11 Years (with risk factors)
  Participants will receive a single injection (age appropriate dose) on Day 1
• Experimental: Cohort 1 Group 3: ≥65 Years
  Participants will receive a single injection (age appropriate dose) on Day 1.
• Experimental: Cohort 1 Group 2: 12-64 Years (with risk factors)
  Participants will receive a single injection (age appropriate dose) on Day 1
• Experimental: Cohort 2 Group 5: 18-64 Years (with risk factors)
  Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
• Experimental: Cohort 2 Group 4: 18-64 Years (with risk factors)
  Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
• Experimental: Cohort 2 Group 6: 18-64 Years (with risk factors)
  Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
• Experimental: Cohort 2 Group 7: ≥65 Years
  Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
• Experimental: Cohort 2 Group 8: ≥65 Years
  Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1
• Experimental: Cohort 2 Group 9: ≥65 Years
  Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

Primary Outcome Measure

Percentage of participants reporting local reactions or systemic events [ Time Frame: For up to 7 days after vaccination ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (14)

Find similar trials in Homestead, FL

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