A Study to Learn About COVID-19 Bivalent BNT162b2 Omicron Containing Vaccine 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 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
- 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
- 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
| Arm | Description | Assigned 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 |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
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 Selected dose, 6 Months to <5 Years (Substudy C, Phase 2/3) |
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 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 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 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 |
|
Recruiting Locations
Kaiser Permanente
Los Angeles, California 90027
Los Angeles, California 90027
Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
Palo Alto, California 94304
Palo Alto, California 94304
Center for Clinical Trials, LLC
Paramount, California 90723
Paramount, California 90723
Peninsula Research Associates
Rolling Hills Estates, California 90274
Rolling Hills Estates, California 90274
Stanford University Medical Center
Stanford, California 94305
Stanford, California 94305
PediaClinic
Highlands Ranch, Colorado 80126
Highlands Ranch, Colorado 80126
Yale University School of Medicine
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Yale University School of Medicine
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Yale University- Yale Center for Clinical Investigation
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Emerson Clinical Research Institute
Washington, District of Columbia 20011
Washington, District of Columbia 20011
Meridian Clinical Research, LLC
Washington, District of Columbia 20016
Washington, District of Columbia 20016
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Acevedo Clinical Research Associates
Miami, Florida 33142
Miami, Florida 33142
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
Orlando, Florida 32801
Emory University School of Medicine
Atlanta, Georgia 30322-
Atlanta, Georgia 30322-
Emory Children's Center Illness Pod
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Emory Children's Center
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Emory University School of Medicine
Atlanta, Georgia 30322
Atlanta, Georgia 30322
SKY Clinical Research Network Group-Blake
Union City, Georgia 30291
Union City, Georgia 30291
Alliance for Multispecialty Research, LLC
Newton, Kansas 67114
Newton, Kansas 67114
Alliance for Multispecialty Research, LLC
Wichita, Kansas 67207
Wichita, Kansas 67207
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana 71101
Shreveport, Louisiana 71101
Center for Immunization Research Inpatient Unit
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Johns Hopkins Center for Immunization Outpatient Clinic
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Boston medical Center (investigational Pharmacy Services, IP delivery)
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Meridian Clinical Research, LLC
Hastings, Nebraska 68901
Hastings, Nebraska 68901
Meridian Clinical Research, LLC
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Rutgers University
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
Rochester Clinical Research, Inc.
Rochester, New York 14609
Rochester, New York 14609
University of Rochester Medical Center
Rochester, New York 14642
Rochester, New York 14642
Duke Vaccine and Trials Unit
Durham, North Carolina 27703
Durham, North Carolina 27703
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Senders Pediatrics
Cleveland, Ohio 44121
Cleveland, Ohio 44121
Aventiv Research Inc
Columbus, Ohio 43213
Columbus, Ohio 43213
Cyn3rgy Research
Gresham, Oregon 97030
Gresham, Oregon 97030
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania 16506
Erie, Pennsylvania 16506
Velocity Clinical Research, Providence
East Greenwich, Rhode Island 02818
East Greenwich, Rhode Island 02818
Coastal Pediatric Research
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Tribe Clinical Research, LLC
Greenville, South Carolina 29607
Greenville, South Carolina 29607
Coastal Pediatric Research
Summerville, South Carolina 29486
Summerville, South Carolina 29486
Clinical Research Associates Inc
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Cedar Health Research
Dallas, Texas 75251
Dallas, Texas 75251
Proactive Clinical Research, LLC
Edinburg, Texas 78539
Edinburg, Texas 78539
Village Health Partners - Frisco Medical Village
Frisco, Texas 75033
Frisco, Texas 75033
Texas Children's Hospital
Houston, Texas 77030
Houston, Texas 77030
DM Clinical Research
Houston, Texas 77065
Houston, Texas 77065
ACRC Trials (Administrative Site)
Plano, Texas 75024
Plano, Texas 75024
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia 22902
Charlottesville, Virginia 22902
Virginia Research Center
Midlothian, Virginia 23114
Midlothian, Virginia 23114
Seattle Children's- Building Cure
Seattle, Washington 98101
Seattle, Washington 98101
Seattle Children's Hospital
Seattle, Washington 98105
Seattle, Washington 98105
More Details
- NCT ID
- NCT05543616
- Status
- Recruiting
- Sponsor
- BioNTech SE