Official Title
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
Brief Summary

The purpose of this clinical trial is to learn about the safety, extent of the sideeffects, and immune responses of the study vaccine (called variant-adapted BNT162b2RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies orsubstudies based on age group and prior history of COVID-19 vaccinations. Allparticipants in each of the 5 sub-studies will receive study vaccine as a shot dependingon 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 2 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.

Detailed Description

Not Provided

Recruiting
SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Injection in the muscle

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Injection in the muscle

Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Injection in the muscle

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose

Injection in the muscle

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

Injection in the muscle

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose

Injection in the muscle

Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

injection in the muscle

Eligibility Criteria

Substudy A

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Previous or current diagnosis of multisystem inflammatory syndrome in children
(MIS-C).

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).

- Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination, or individuals who
receive treatment with immunosuppressive therapy.

- Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic lupus
erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.

- Any history of myocarditis or pericarditis.

- Previous vaccination with any COVID-19 vaccine.

- Receipt of systemic treatment with known immunosuppressant medications (including
cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy,
within 60 days before enrollment through the conclusion of the study. Systemic
corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent
for persons who weigh >10 kg) for ≥14 days is prohibited from 28 days prior to
enrollment through 28 days after administration of study intervention.

- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except
palivizumab), from 60 days before study intervention administration, or receipt of
any passive antibody therapy specific to COVID-19 from 90 days before study
intervention administration, or planned receipt throughout the study.

Substudy B

Inclusion Criteria:

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

Exclusion Criteria:

- Previous or current diagnosis of MIS-C.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).

- Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination, or individuals who
receive treatment with immunosuppressive therapy.

- Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic lupus
erythematosus.

- Prior receipt of any COVID 19 vaccine other than BNT162b2.

- Receipt of systemic treatment with known immunosuppressant medications (including
cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy,
within 60 days before enrollment through the conclusion of the study. Systemic
corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent
for persons who weigh >10 kg) for ≥14 days is prohibited from 28 days prior to
enrollment through 28 days after administration of study intervention.

- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except
palivizumab), from 60 days before study intervention administration, or receipt of
any passive antibody therapy specific to COVID-19 from 90 days before study
intervention administration, or planned receipt throughout the study.

Substudy C

Inclusion Criteria:

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

Exclusion Criteria:

- Previous or current diagnosis of MIS-C.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).

- Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination, or individuals who
receive treatment with immunosuppressive therapy.

- Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic lupus
erythematosus.

- Prior receipt of any COVID 19 vaccine other than BNT162b2.

- Receipt of systemic treatment with known immunosuppressant medications (including
cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy,
within 60 days before enrollment through the conclusion of the study. Systemic
corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent
for persons who weigh >10 kg) for ≥14 days is prohibited from 28 days prior to
enrollment through 28 days after administration of study intervention.

- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except
palivizumab), from 60 days before study intervention administration, or receipt of
any passive antibody therapy specific to COVID-19 from 90 days before study
intervention administration, or planned receipt throughout the study.

Substudy D

Inclusion Criteria:

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

Exclusion Criteria:

- Previous or current diagnosis of MIS-C.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).

- Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination, or individuals who
receive treatment with immunosuppressive therapy.

- Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic lupus
erythematosus.

- Female who is pregnant or breastfeeding.

- Prior receipt of any COVID 19 vaccine other than BNT162b2.

- Receipt of systemic treatment with known immunosuppressant medications (including
cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy,
within 60 days before enrollment through the conclusion of the study. Systemic
corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent
for persons who weigh >10 kg) for ≥14 days is prohibited from 28 days prior to
enrollment through 28 days after administration of study intervention.

- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except
palivizumab), from 60 days before study intervention administration, or receipt of
any passive antibody therapy specific to COVID-19 from 90 days before study
intervention administration, or planned receipt throughout the study.

Substudy E

Inclusion Criteria:

- Healthy male or female participants ≥2 years to <12 years of age, at the time of
enrollment.

Exclusion Criteria:

- Previous or current diagnosis of MIS-C.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).

- Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination, or individuals who
receive treatment with immunosuppressive therapy.

- Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic lupus
erythematosus.

- Any history of myocarditis or pericarditis.

- Female who is pregnant or breastfeeding.

- Previous vaccination with any COVID 19 vaccine.

- Receipt of systemic treatment with known immunosuppressant medications (including
cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy,
within 60 days before enrollment through the conclusion of the study. Systemic
corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent
for persons who weigh >10 kg) for ≥14 days is prohibited from 28 days prior to
enrollment through 28 days after administration of study intervention.

- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except
palivizumab), from 60 days before study intervention administration, or receipt of
any passive antibody therapy specific to COVID-19 from 90 days before study
intervention administration, or planned receipt throughout the study.

Eligibility Gender
All
Eligibility Age
Minimum: 6 Months ~ Maximum: 11 Years
Countries
Brazil
Puerto Rico
South Africa
United States
Locations

UAB Child Health Research Unit (CHRU)
Birmingham, Alabama, United States

UAB Child Health Research Unit (CHRU)
Birmingham, Alabama, United States

Phoenix Children's Hospital
Phoenix, Arizona, United States

Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States

Advanced Research Center Inc.
Anaheim, California, United States

Paradigm Clinical Research Centers, Inc
La Mesa, California, United States

Hoag Medical Group Foothill Ranch
Lake Forest, California, United States

Kaiser Permanente
Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States

Kaiser Permanente Oakland
Oakland, California, United States

Kaiser Permanente Oakland
Oakland, California, United States

Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
Palo Alto, California, United States

Center for Clinical Trials, LLC
Paramount, California, United States

Peninsula Research Associates
Rolling Hills Estates, California, United States

Kaiser Permanente Sacramento
Sacramento, California, United States

Kaiser Permanente Sacramento
Sacramento, California, United States

Paradigm Clinical Research, LLC
San Diego, California, United States

Kaiser Permanente Santa Clara
Santa Clara, California, United States

Kaiser Permanente Santa Clara
Santa Clara, California, United States

Stanford University Medical Center
Stanford, California, United States

PediaClinic
Highlands Ranch, Colorado, United States

Yale University School of Medicine
New Haven, Connecticut, United States

Yale University School of Medicine
New Haven, Connecticut, United States

Yale University- Yale Center for Clinical Investigation
New Haven, Connecticut, United States

Emerson Clinical Research Institute - Washington - Connecticut Avenue
Washington, District of Columbia, United States

Emerson Clinical Research Institute
Washington, District of Columbia, United States

Children's National Medical Center
Washington, District of Columbia, United States

Emerson Clinical Research Institute
Washington, District of Columbia, United States

Meridian Clinical Research, LLC
Washington, District of Columbia, United States

Indago Research & Health Center, Inc
Hialeah, Florida, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States

Acevedo Clinical Research Associates
Miami, Florida, United States

Bio-Medical Research LLC
Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States

Accel Research Sites Network- Nona Pediatric Center
Orlando, Florida, United States

SEC Clinical Research
Pensacola, Florida, United States

SEC Clinical Research
Pensacola, Florida, United States

Asclepes Research Center - Spring Hill
Spring Hill, Florida, United States

PAS Research
Tampa, Florida, United States

PAS Research
Tampa, Florida, United States

Emory University School of Medicine
Atlanta, Georgia, United States

Emory Children's Center Illness Pod
Atlanta, Georgia, United States

Emory Children's Center
Atlanta, Georgia, United States

Emory University Investigational Drug Service
Atlanta, Georgia, United States

Emory University School of Medicine
Atlanta, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States

Saltzer Health
Nampa, Idaho, United States

The Iowa Clinic, P.C.
Ankeny, Iowa, United States

The Iowa Clinic, P.C.
West Des Moines, Iowa, United States

The Iowa Clinic
West Des Moines, Iowa, United States

Alliance for Multispecialty Research, LLC
Newton, Kansas, United States

Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States

Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States

Center for Immunization Research Inpatient Unit
Baltimore, Maryland, United States

Johns Hopkins Center for Immunization Outpatient Clinic
Baltimore, Maryland, United States

Boston medical Center (investigational Pharmacy Services, IP delivery)
Boston, Massachusetts, United States

Boston Medical Center
Boston, Massachusetts, United States

Boston Medical Center Crosstown Building
Boston, Massachusetts, United States

SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States

Meridian Clinical Research, LLC
Hastings, Nebraska, United States

Velocity Clinical Research, Lincoln
Lincoln, Nebraska, United States

Midwest Children's Health Research Institute
Lincoln, Nebraska, United States

Children's Hospital & Medical Center
Omaha, Nebraska, United States

Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States

Rutgers University
New Brunswick, New Jersey, United States

Meridian Clinical Research, LLC
Binghamton, New York, United States

Jacobi Medical Center
Bronx, New York, United States

SUNY Downstate Health Sciences University
Brooklyn, New York, United States

Rochester Clinical Research, LLC
Rochester, New York, United States

University of Rochester Medical Center
Rochester, New York, United States

Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States

Duke University - Main Hospital and Clinics
Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States

Senders Pediatrics
Cleveland, Ohio, United States

Velocity Clinical Research, Cleveland
Cleveland, Ohio, United States

Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States

Dayton Clinical Research
Dayton, Ohio, United States

PriMED Clinical Research
Dayton, Ohio, United States

Cyn3rgy Research
Gresham, Oregon, United States

Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States

Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States

Coastal Pediatric Research
Charleston, South Carolina, United States

Coastal Pediatric Research
Charleston, South Carolina, United States

Tribe Clinical Research, LLC
Greenville, South Carolina, United States

Coastal Pediatric Research
Summerville, South Carolina, United States

Coastal Pediatric Research
Summerville, South Carolina, United States

St. Jude Children's Research Hospital
Memphis, Tennessee, United States

Clinical Research Associates Inc
Nashville, Tennessee, United States

Driscoll Children's Hospital
Corpus Christi, Texas, United States

Cedar Health Research
Dallas, Texas, United States

Proactive Clinical Research, LLC
Edinburg, Texas, United States

ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
Frisco, Texas, United States

University of Texas Medical Branch
Galveston, Texas, United States

Texas Children's Hospital
Houston, Texas, United States

DM Clinical Research
Houston, Texas, United States

Dr. Ruben Aleman and Associates
McAllen, Texas, United States

ACRC Trials (Administrative Site)
Plano, Texas, United States

Alliance for Multispecialty Research, LLC
Syracuse, Utah, United States

Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States

Virginia Research Center
Midlothian, Virginia, United States

Virginia Research Center
Midlothian, Virginia, United States

Seattle Children's- Building Cure
Seattle, Washington, United States

Seattle Children's Hospital
Seattle, Washington, United States

Obras Sociais Irma Dulce
Salvador, Bahia, Brazil

Consultoria em Controle de Infecção Hospitalar
Belo Horizonte, Minas Gerais, Brazil

Centro Médico São Francisco
Curitiba, Paraná, Brazil

Centro Médico São Francisco
Curitiba, Paraná, Brazil

Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
Natal, RIO Grande DO Norte, Brazil

Hospital de Clínicas de Porto Alegre - Escritório de Projetos e Parcerias Estratégicas
Porto Alegre, RIO Grande DO SUL, Brazil

Hospital de Clinicas de Porto Alegre
Porto Alegre, RIO Grande DO SUL, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, SÃO Paulo, Brazil

CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil

Clinical Research Puerto Rico
Guayama, Puerto Rico

University of Puerto Rico - Medical Sciences Campus
San Juan, Puerto Rico

Synergy Biomed Research Institute
East London, Eastern CAPE, South Africa

REIMED Reiger Park
Boksburg, Gauteng, South Africa

Wits RHI
Johannesburg, Gauteng, South Africa

University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg, Gauteng, South Africa

Wits VIDA Nkanyezi Research Unit
Johannesburg, Gauteng, South Africa

Newtown Clinical Research
Johannesburg, Gauteng, South Africa

Botho Ke Bontle Health Services
Pretoria, Gauteng, South Africa

Sandton Medical Research Centre
Sandton, Gauteng, South Africa

Gole Biomed Research Centre
Polokwane, Limpopo, South Africa

Perinatal HIV Research Unit (PHRU)
Klerksdorp, North-west, South Africa

TREAD Research
Cape Town, Western CAPE, South Africa

Contacts

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
Covid-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
MeSH Terms
COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome