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.
Not Provided
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
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.
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
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer