A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDREN

Status: Recruiting
Location: See all (134) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. * Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. * Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. * Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 11
Healthy Volunteers: t
View:

• Phase 1: Healthy male or female participants ≥6 months to \<4 years 3 months of age, at the time of randomization.

• Phase 2/3: Healthy male or female participants ≥6 months to \<5 years of age at the time of randomization/enrollment.

⁃ \- Healthy male or female participants = ≥6 months to \<5 years of age, at the time of enrollment.

⁃ \- Healthy male or female participants ≥6 months to \<5 years of age, at the time of randomization/enrollment.

⁃ \- Healthy male or female participants ≥5 years to \<12 years of age, at the time of enrollment.

⁃ \- Healthy male or female participants ≥5 years to \<12 years of age, at the time of enrollment.

Locations
United States
Alabama
UAB Child Health Research Unit (CHRU)
ACTIVE_NOT_RECRUITING
Birmingham
UAB Child Health Research Unit (CHRU)
NOT_YET_RECRUITING
Birmingham
Arkansas
Northwest Arkansas Pediatric Clinic
NOT_YET_RECRUITING
Fayetteville
Arizona
Phoenix Children's Hospital
ACTIVE_NOT_RECRUITING
Phoenix
California
Advanced Research Center Inc.
RECRUITING
Anaheim
Paradigm Clinical Research Centers, Inc
RECRUITING
La Mesa
Hoag Medical Group Foothill Ranch
NOT_YET_RECRUITING
Lake Forest
Kaiser Permanente
ACTIVE_NOT_RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
NOT_YET_RECRUITING
Newport Beach
Kaiser Permanente Oakland
NOT_YET_RECRUITING
Oakland
Kaiser Permanente Oakland
RECRUITING
Oakland
Kaiser Permanente Oakland
ACTIVE_NOT_RECRUITING
Oakland
Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
RECRUITING
Palo Alto
Center for Clinical Trials, LLC
ACTIVE_NOT_RECRUITING
Paramount
Peninsula Research Associates
ACTIVE_NOT_RECRUITING
Rolling Hills Estates
Kaiser Permanente Sacramento
NOT_YET_RECRUITING
Sacramento
Kaiser Permanente Sacramento
RECRUITING
Sacramento
Kaiser Permanente Sacramento
ACTIVE_NOT_RECRUITING
Sacramento
Paradigm Clinical Research, LLC
RECRUITING
San Diego
Kaiser Permanente Santa Clara
RECRUITING
Santa Clara
Kaiser Permanente Santa Clara
NOT_YET_RECRUITING
Santa Clara
Stanford University Medical Center
RECRUITING
Stanford
Colorado
PediaClinic
ACTIVE_NOT_RECRUITING
Highlands Ranch
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Yale University School of Medicine
ACTIVE_NOT_RECRUITING
New Haven
Yale University- Yale Center for Clinical Investigation
ACTIVE_NOT_RECRUITING
New Haven
Washington, D.c.
Children's National Medical Center
ACTIVE_NOT_RECRUITING
Washington D.c.
Emerson Clinical Research Institute
RECRUITING
Washington D.c.
Emerson Clinical Research Institute
RECRUITING
Washington D.c.
Emerson Clinical Research Institute - Washington - Connecticut Avenue
RECRUITING
Washington D.c.
Meridian Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Indago Research & Health Center, Inc
RECRUITING
Hialeah
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
ACTIVE_NOT_RECRUITING
Jacksonville
Acevedo Clinical Research Associates
ACTIVE_NOT_RECRUITING
Miami
Bio-Medical Research LLC
RECRUITING
Miami
Accel Research Sites Network- Nona Pediatric Center
NOT_YET_RECRUITING
Orlando
Clinical Neuroscience Solutions, Inc.
ACTIVE_NOT_RECRUITING
Orlando
SEC Clinical Research
RECRUITING
Pensacola
SEC Clinical Research
ACTIVE_NOT_RECRUITING
Pensacola
SEC Clinical Research
RECRUITING
Pensacola
Asclepes Research Center - Spring Hill
NOT_YET_RECRUITING
Spring Hill
PAS Research
ACTIVE_NOT_RECRUITING
Tampa
PAS Research
NOT_YET_RECRUITING
Tampa
Georgia
Emory Children's Center
RECRUITING
Atlanta
Emory Children's Center Illness Pod
RECRUITING
Atlanta
Emory University Investigational Drug Service
RECRUITING
Atlanta
Emory University School of Medicine
RECRUITING
Atlanta
Emory University School of Medicine
RECRUITING
Atlanta
Rophe Adult and Pediatric Medicine/SKYCRNG
ACTIVE_NOT_RECRUITING
Union City
Iowa
The Iowa Clinic, P.C.
RECRUITING
Ankeny
The Iowa Clinic
RECRUITING
West Des Moines
The Iowa Clinic, P.C.
RECRUITING
West Des Moines
Idaho
Saltzer Health
NOT_YET_RECRUITING
Nampa
Kansas
Alliance for Multispecialty Research, LLC
ACTIVE_NOT_RECRUITING
Newton
Alliance for Multispecialty Research, LLC
ACTIVE_NOT_RECRUITING
Wichita
Louisiana
Louisiana State University Health Sciences Shreveport
RECRUITING
Shreveport
Massachusetts
Boston Medical Center
ACTIVE_NOT_RECRUITING
Boston
Boston medical Center (investigational Pharmacy Services, IP delivery)
RECRUITING
Boston
Boston Medical Center Crosstown Building
ACTIVE_NOT_RECRUITING
Boston
Maryland
Center for Immunization Research Inpatient Unit
RECRUITING
Baltimore
Johns Hopkins Center for Immunization Outpatient Clinic
RECRUITING
Baltimore
Mississippi
SKY Integrative Medical Center/SKYCRNG
ACTIVE_NOT_RECRUITING
Ridgeland
North Carolina
Atrium Health - Carolinas Medical Center
ACTIVE_NOT_RECRUITING
Charlotte
Duke University - Main Hospital and Clinics
ACTIVE_NOT_RECRUITING
Durham
Nebraska
Velocity Clinical Research, Hastings
ACTIVE_NOT_RECRUITING
Hastings
Midwest Children's Health Research Institute
NOT_YET_RECRUITING
Lincoln
Velocity Clinical Research, Lincoln
ACTIVE_NOT_RECRUITING
Lincoln
Children's Hospital & Medical Center
ACTIVE_NOT_RECRUITING
Omaha
New Jersey
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
Rutgers University
RECRUITING
New Brunswick
New York
Meridian Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Binghamton
SUNY Downstate Health Sciences University
ACTIVE_NOT_RECRUITING
Brooklyn
Rochester Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Rochester
University of Rochester Medical Center
RECRUITING
Rochester
Jacobi Medical Center
RECRUITING
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Senders Pediatrics
RECRUITING
Cleveland
Velocity Clinical Research, Cleveland
ACTIVE_NOT_RECRUITING
Cleveland
Centricity Research Columbus Ohio Multispecialty
ACTIVE_NOT_RECRUITING
Columbus
Dayton Clinical Research
RECRUITING
Dayton
PriMED Clinical Research
RECRUITING
Dayton
Oregon
Cyn3rgy Research
RECRUITING
Gresham
Pennsylvania
Allegheny Health and Wellness Pavilion
RECRUITING
Erie
Rhode Island
Velocity Clinical Research, Providence
ACTIVE_NOT_RECRUITING
East Greenwich
South Carolina
Coastal Pediatric Research
ACTIVE_NOT_RECRUITING
Charleston
Coastal Pediatric Research
RECRUITING
Charleston
Tribe Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Greenville
Coastal Pediatric Research
ACTIVE_NOT_RECRUITING
Summerville
Coastal Pediatric Research
RECRUITING
Summerville
Tennessee
St. Jude Children's Research Hospital
ACTIVE_NOT_RECRUITING
Memphis
Clinical Research Associates Inc
ACTIVE_NOT_RECRUITING
Nashville
Texas
Driscoll Children's Hospital
RECRUITING
Corpus Christi
Cedar Health Research
ACTIVE_NOT_RECRUITING
Dallas
Proactive Clinical Research LLC
RECRUITING
Edinburg
Proactive Clinical Research, LLC
RECRUITING
Edinburg
ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
RECRUITING
Frisco
University of Texas Medical Branch
RECRUITING
Galveston
DM Clinical Research
ACTIVE_NOT_RECRUITING
Houston
DM Clinical Research- Cyfair
RECRUITING
Houston
Texas Children's Hospital
RECRUITING
Houston
Dr. Ruben Aleman and Associates
ACTIVE_NOT_RECRUITING
Mcallen
ACRC Trials (Administrative Site)
RECRUITING
Plano
Utah
Alliance for Multispecialty Research, LLC
NOT_YET_RECRUITING
Syracuse
Virginia
Pediatric Research of Charlottesville, LLC
ACTIVE_NOT_RECRUITING
Charlottesville
Virginia Research Center
ACTIVE_NOT_RECRUITING
Midlothian
Virginia Research Center
RECRUITING
Midlothian
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Seattle Children's- Building Cure
RECRUITING
Seattle
Other Locations
Brazil
Consultoria em Controle de Infecção Hospitalar
NOT_YET_RECRUITING
Belo Horizonte
Centro Médico São Francisco
ACTIVE_NOT_RECRUITING
Curitiba
Centro Médico São Francisco
NOT_YET_RECRUITING
Curitiba
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
ACTIVE_NOT_RECRUITING
Natal
Hospital de Clinicas de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Hospital de Clínicas de Porto Alegre - Escritório de Projetos e Parcerias Estratégicas
NOT_YET_RECRUITING
Porto Alegre
Obras Sociais Irma Dulce
ACTIVE_NOT_RECRUITING
Salvador
Fundação Faculdade Regional de Medicina de São José do Rio Preto
ACTIVE_NOT_RECRUITING
São José Do Rio Preto
CEPIC - Centro Paulista de Investigação Clínica
NOT_YET_RECRUITING
São Paulo
Puerto Rico
Clinical Research Puerto Rico
RECRUITING
Guayama
University of Puerto Rico - Medical Sciences Campus
RECRUITING
San Juan
South Africa
REIMED Reiger Park
ACTIVE_NOT_RECRUITING
Boksburg
TREAD Research
ACTIVE_NOT_RECRUITING
Cape Town
Synergy Biomed Research Institute
ACTIVE_NOT_RECRUITING
East London
Newtown Clinical Research
ACTIVE_NOT_RECRUITING
Johannesburg
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
ACTIVE_NOT_RECRUITING
Johannesburg
Wits RHI
ACTIVE_NOT_RECRUITING
Johannesburg
Wits VIDA Nkanyezi Research Unit
ACTIVE_NOT_RECRUITING
Johannesburg
Perinatal HIV Research Unit (PHRU)
ACTIVE_NOT_RECRUITING
Klerksdorp
Merclinco
ACTIVE_NOT_RECRUITING
Middelburg
Tsitsikamma Clinical Research Initiative (TCRI)
ACTIVE_NOT_RECRUITING
Plettenberg Bay
Gole Biomed Research Centre
ACTIVE_NOT_RECRUITING
Polokwane
Gole Biomed Research Centre
RECRUITING
Polokwane
Botho Ke Bontle Health Services
ACTIVE_NOT_RECRUITING
Pretoria
Sandton Medical Research Centre
ACTIVE_NOT_RECRUITING
Sandton
Jaymed Research
ACTIVE_NOT_RECRUITING
Welkom
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-09-23
Estimated Completion Date: 2026-06-16
Participants
Target number of participants: 4292
Treatments
Experimental: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Experimental: 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Experimental: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Experimental: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule
Injection in the muscle at 0- and 8-weeks
Experimental: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule
Injection in the muscle at 0- and 8-weeks
Experimental: 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
Injection in the muscle, 2 doses 2 months apart
Experimental: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
Injection in the muscle, 1 dose
Experimental: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
Injection in the muscle, 1 dose
Experimental: 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
Injection in the muscle, 1 dose
Experimental: 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Experimental: 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Experimental: 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Experimental: 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
Experimental: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule
Injection in the muscle at 0-, 3-, and 11-weeks
Experimental: 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)
Injection in the muscle, 1 dose
Experimental: 10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule
Injection in the muscle at 0- and 8-weeks
Sponsors
Collaborators: Pfizer
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov