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 bivalent BNT162b2 Omicron containing vaccine) in healthy children. The trial is divided into 4 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 4 sub-studies study vaccine as a shot depending on what group they are in. - Substudy A design: 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 which may be followed by a fourth dose of study vaccine. - Substudy B design: includes 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: 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.

Conditions

Eligibility

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

Inclusion Criteria

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

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. - 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: - Health 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.

Study Design

Phase
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 6-months post-Dose 3
  • 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 A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and 6-months post-Dose 3
  • 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 A, Phase 1)
Injection in the muscle at 0-, 3-, and 11-weeks and 6-months post-Dose 3
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
    Injection in the muscle
Experimental
Selected dose, 6 Months to <4 Years 3 Months (Substudy A, Phase 2/3) - 0/3/11 week primary series
Injection in the muscle at 0-, 3-, and 11-weeks and 6-months post-Dose 3
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) Substudy A Ph 2/3 Selected Dose
    Injection in the muscle
Experimental
Selected dose, 6 Months to <4 Years 3 Months (Substudy A, Phase 2/3) - 0/8/16 week primary series
Injection in the muscle at 0-, 8-, and 16-weeks and 6-months post-Dose 3
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.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
Selected dose, 6 Months to <5 Years (Substudy C, Phase 2/3)
Injection in the muscle, 1 dose
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) Substudy C Ph 2/3 Selected 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 6-months post-Dose 3
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.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 6-months post-Dose 3
  • Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 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 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

Recruiting Locations

Kaiser Permanente
Los Angeles, California 90027

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

Center for Clinical Trials, LLC
Paramount, California 90723

Peninsula Research Associates
Rolling Hills Estates, California 90274

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, District of Columbia 20011

Meridian Clinical Research, LLC
Washington, District of Columbia 20016

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida 32256

Acevedo Clinical Research Associates
Miami, Florida 33142

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801

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 School of Medicine
Atlanta, Georgia 30322

SKY Clinical Research Network Group-Blake
Union City, Georgia 30291

Alliance for Multispecialty Research, LLC
Newton, Kansas 67114

Alliance for Multispecialty Research, LLC
Wichita, Kansas 67207

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

Meridian Clinical Research, LLC
Hastings, Nebraska 68901

Meridian Clinical Research, LLC
Lincoln, Nebraska 68510

Rutgers University
New Brunswick, New Jersey 08901

Rochester Clinical Research, Inc.
Rochester, New York 14609

University of Rochester Medical Center
Rochester, New York 14642

Duke Vaccine and Trials Unit
Durham, North Carolina 27703

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Senders Pediatrics
Cleveland, Ohio 44121

Aventiv Research Inc
Columbus, Ohio 43213

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

Tribe Clinical Research, LLC
Greenville, South Carolina 29607

Coastal Pediatric Research
Summerville, South Carolina 29486

Clinical Research Associates Inc
Nashville, Tennessee 37203

Cedar Health Research
Dallas, Texas 75251

Proactive Clinical Research, LLC
Edinburg, Texas 78539

Village Health Partners - Frisco Medical Village
Frisco, Texas 75033

Texas Children's Hospital
Houston, Texas 77030

DM Clinical Research
Houston, Texas 77065

ACRC Trials (Administrative Site)
Plano, Texas 75024

Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia 22902

Virginia Research Center
Midlothian, Virginia 23114

Seattle Children's- Building Cure
Seattle, Washington 98101

Seattle Children's Hospital
Seattle, Washington 98105

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.