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
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
- collaborator INDUSTRY
- lead INDUSTRY
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
More Related Trials
-
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
NCT02534935 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
NCT00879814 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
NCT01461980 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
NCT07794748 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
NCT05489328 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT03691610 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults
NCT00896064 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
NCT00962624 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
NCT04649151 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
NCT06182124 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
NCT01119625 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
NCT07660198 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years
NCT02531698 ·Status: COMPLETED ·Phase: PHASE2
-
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
NCT03760146 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
NCT05436834 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
NCT01768117 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
NCT00387725 ·Status: COMPLETED ·Phase: PHASE2
-
Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
NCT00914732 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
NCT03135834 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
NCT00546572 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
NCT07135986 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
NCT06838000 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
NCT01299480 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
NCT00053495 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection
NCT06672055 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2