A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

Purpose

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 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.

Conditions

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

Eligibility

Eligible Ages
Between 6 Months and 11 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    Injection in the muscle
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
    Injection in the muscle
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
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
    Injection in the muscle
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
    Injection in the muscle
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
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
    injection in the muscle
Experimental
Selected 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
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
    Injection in the muscle
Experimental
Selected 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
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
    Injection in the muscle
Experimental
3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
Injection in the muscle, 2 doses 2 months apart
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    Injection in the muscle
Experimental
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    Injection in the muscle
Experimental
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    Injection in the muscle
Experimental
6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
    Injection in the muscle
Experimental
10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
Experimental
10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
Experimental
10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
Experimental
10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
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
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    Injection in the muscle
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
    Injection in the muscle
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
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 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
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
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
Experimental
6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
    Injection in the muscle
Experimental
10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
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
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
    Injection in the muscle
Experimental
Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose
Injection in the muscle, 1 dose
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
    Injection in the muscle
Experimental
Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose
Injection in the muscle, 1 dose
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
    Injection in the muscle
Experimental
3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1)
Injection in the muscle, 1 dose
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
    Injection in the muscle
Experimental
10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)
Injection in the muscle, 1 dose
  • Biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
    injection in the muscle

Recruiting Locations

Advanced Research Center Inc.
Anaheim, California 92805

Paradigm Clinical Research Centers, Inc
La Mesa, California 91942

Kaiser Permanente Oakland
Oakland, California 94611

Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
Palo Alto, California 94304

Center for Clinical Trials, LLC
Paramount, California 90723

Kaiser Permanente Sacramento
Sacramento, California 95815

Paradigm Clinical Research, LLC
San Diego, California 92108

Kaiser Permanente Santa Clara
Santa Clara, California 95051

Stanford University Medical Center
Stanford, California 94305

PediaClinic
Highlands Ranch, Colorado 80126

Yale University School of Medicine
New Haven, Connecticut 06510

Yale University School of Medicine
New Haven, Connecticut 06519

Yale University- Yale Center for Clinical Investigation
New Haven, Connecticut 06519

Emerson Clinical Research Institute - Washington - Connecticut Avenue
Washington, District of Columbia 20009

Emerson Clinical Research Institute
Washington, District of Columbia 20009

Emerson Clinical Research Institute
Washington, District of Columbia 20011

Indago Research & Health Center, Inc
Hialeah, Florida 33012

Acevedo Clinical Research Associates
Miami, Florida 33142

Bio-Medical Research LLC
Miami, Florida 33144

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801

SEC Clinical Research
Pensacola, Florida 32501

SEC Clinical Research
Pensacola, Florida 32503

PAS Research
Tampa, Florida 33613

Emory University School of Medicine
Atlanta, Georgia 30322-

Emory Children's Center Illness Pod
Atlanta, Georgia 30322

Emory Children's Center
Atlanta, Georgia 30322

Emory University Investigational Drug Service
Atlanta, Georgia 30322

Emory University School of Medicine
Atlanta, Georgia 30322

The Iowa Clinic, P.C.
Ankeny, Iowa 50023

The Iowa Clinic, P.C.
West Des Moines, Iowa 50266

The Iowa Clinic
West Des Moines, Iowa 50266

Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana 71101

Center for Immunization Research Inpatient Unit
Baltimore, Maryland 21224

Johns Hopkins Center for Immunization Outpatient Clinic
Baltimore, Maryland 21224

Boston medical Center (investigational Pharmacy Services, IP delivery)
Boston, Massachusetts 02118

Boston Medical Center
Boston, Massachusetts 02118

Boston Medical Center Crosstown Building
Boston, Massachusetts 02119

SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157

Meridian Clinical Research, LLC
Hastings, Nebraska 68901

Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901

Rutgers University
New Brunswick, New Jersey 08901

Meridian Clinical Research, LLC
Binghamton, New York 13905

Jacobi Medical Center
Bronx, New York 10461

SUNY Downstate Health Sciences University
Brooklyn, New York 11203

University of Rochester Medical Center
Rochester, New York 14642

Duke University - Main Hospital and Clinics
Durham, North Carolina 27703

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Senders Pediatrics
Cleveland, Ohio 44121

Velocity Clinical Research, Cleveland
Cleveland, Ohio 44122

Dayton Clinical Research
Dayton, Ohio 45409

PriMED Clinical Research
Dayton, Ohio 45429

Cyn3rgy Research
Gresham, Oregon 97030

Allegheny Health and Wellness Pavilion
Erie, Pennsylvania 16506

Velocity Clinical Research, Providence
East Greenwich, Rhode Island 02818

Coastal Pediatric Research
Charleston, South Carolina 29414

Coastal Pediatric Research
Summerville, South Carolina 29486

Clinical Research Associates Inc
Nashville, Tennessee 37203

Driscoll Children's Hospital
Corpus Christi, Texas 78411

Proactive Clinical Research, LLC
Edinburg, Texas 78539

ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
Frisco, Texas 75033

University of Texas Medical Branch
Galveston, Texas 77555

Texas Children's Hospital
Houston, Texas 77030

DM Clinical Research
Houston, Texas 77065

Dr. Ruben Aleman and Associates
McAllen, Texas 78504

ACRC Trials (Administrative Site)
Plano, Texas 75024

Virginia Research Center
Midlothian, Virginia 23114

Seattle Children's- Building Cure
Seattle, Washington 98101

Seattle Children's Hospital
Seattle, Washington 98105

Clinical Research Puerto Rico
Guayama, Puerto Rico 00784

University of Puerto Rico - Medical Sciences Campus
San Juan, Puerto Rico 00935

More Details

NCT ID
NCT05543616
Status
Recruiting
Sponsor
BioNTech SE

Study Contact

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