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 5 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 Sex
- 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 ≥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. - 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
| 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 approximately 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 approximately 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 approximately 6-months post-Dose 3 |
|
|
Experimental 10 microgram 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 |
|
|
Experimental 10 microgram 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 |
|
|
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 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 approximately 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 approximately 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 approximately 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 |
|
|
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 |
|
|
Experimental 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose |
Injection in the muscle, 1 dose |
|
|
Experimental 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose |
Injection in the muscle, 1 dose |
|
|
Experimental 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2) |
Injection in the muscle, 1 dose |
|
|
Experimental 10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule |
Injection in the muscle at 0- and 8-weeks |
|
Recruiting Locations
Advanced Research Center Inc.
Anaheim 5323810, California 5332921 92805
Anaheim 5323810, California 5332921 92805
Paradigm Clinical Research Centers, Inc
La Mesa 5363990, California 5332921 91942
La Mesa 5363990, California 5332921 91942
Kaiser Permanente Oakland
Oakland 5378538, California 5332921 94611
Oakland 5378538, California 5332921 94611
Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
Kaiser Permanente Sacramento
Sacramento 5389489, California 5332921 95815
Sacramento 5389489, California 5332921 95815
Paradigm Clinical Research, LLC
San Diego 5391811, California 5332921 92108
San Diego 5391811, California 5332921 92108
Kaiser Permanente Santa Clara
Santa Clara 5393015, California 5332921 95051
Santa Clara 5393015, California 5332921 95051
Stanford University Medical Center
Stanford 5398563, California 5332921 94305
Stanford 5398563, California 5332921 94305
Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06519
New Haven 4839366, Connecticut 4831725 06519
Emerson Clinical Research Institute - Washington - Connecticut Avenue
Washington D.C. 4140963, District of Columbia 4138106 20009
Washington D.C. 4140963, District of Columbia 4138106 20009
Emerson Clinical Research Institute
Washington D.C. 4140963, District of Columbia 4138106 20009
Washington D.C. 4140963, District of Columbia 4138106 20009
Emerson Clinical Research Institute
Washington D.C. 4140963, District of Columbia 4138106 20011
Washington D.C. 4140963, District of Columbia 4138106 20011
Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751 33012
Hialeah 4158476, Florida 4155751 33012
Bio-Medical Research LLC
Miami 4164138, Florida 4155751 33144
Miami 4164138, Florida 4155751 33144
SEC Clinical Research
Pensacola 4168228, Florida 4155751 32501
Pensacola 4168228, Florida 4155751 32501
SEC Clinical Research
Pensacola 4168228, Florida 4155751 32503
Pensacola 4168228, Florida 4155751 32503
Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30322-
Atlanta 4180439, Georgia 4197000 30322-
Emory Children's Center Illness Pod
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Emory Children's Center
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Emory University Investigational Drug Service
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
The Iowa Clinic, P.C.
Ankeny 4846960, Iowa 4862182 50023
Ankeny 4846960, Iowa 4862182 50023
The Iowa Clinic, P.C.
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
The Iowa Clinic
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
Louisiana State University Health Sciences Shreveport
Shreveport 4341513, Louisiana 4331987 71101
Shreveport 4341513, Louisiana 4331987 71101
Center for Immunization Research Inpatient Unit
Baltimore 4347778, Maryland 4361885 21224
Baltimore 4347778, Maryland 4361885 21224
Johns Hopkins Center for Immunization Outpatient Clinic
Baltimore 4347778, Maryland 4361885 21224
Baltimore 4347778, Maryland 4361885 21224
Boston medical Center (investigational Pharmacy Services, IP delivery)
Boston 4930956, Massachusetts 6254926 02118
Boston 4930956, Massachusetts 6254926 02118
Rutgers Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08901
New Brunswick 5101717, New Jersey 5101760 08901
Rutgers University
New Brunswick 5101717, New Jersey 5101760 08901
New Brunswick 5101717, New Jersey 5101760 08901
University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
Rochester 5134086, New York 5128638 14642
Jacobi Medical Center
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Senders Pediatrics
Cleveland 5150529, Ohio 5165418 44121
Cleveland 5150529, Ohio 5165418 44121
Dayton Clinical Research
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
PriMED Clinical Research
Dayton 4509884, Ohio 5165418 45429
Dayton 4509884, Ohio 5165418 45429
Cyn3rgy Research
Gresham 5729485, Oregon 5744337 97030
Gresham 5729485, Oregon 5744337 97030
Allegheny Health and Wellness Pavilion
Erie 5188843, Pennsylvania 6254927 16506
Erie 5188843, Pennsylvania 6254927 16506
Coastal Pediatric Research
Charleston 4574324, South Carolina 4597040 29414
Charleston 4574324, South Carolina 4597040 29414
Coastal Pediatric Research
Summerville 4597919, South Carolina 4597040 29486
Summerville 4597919, South Carolina 4597040 29486
Driscoll Children's Hospital
Corpus Christi 4683416, Texas 4736286 78411
Corpus Christi 4683416, Texas 4736286 78411
Proactive Clinical Research LLC
Edinburg 4688275, Texas 4736286 78539
Edinburg 4688275, Texas 4736286 78539
Proactive Clinical Research, LLC
Edinburg 4688275, Texas 4736286 78539
Edinburg 4688275, Texas 4736286 78539
ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
Frisco 4692559, Texas 4736286 75033
Frisco 4692559, Texas 4736286 75033
University of Texas Medical Branch
Galveston 4692883, Texas 4736286 77555
Galveston 4692883, Texas 4736286 77555
Texas Children's Hospital
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
DM Clinical Research- Cyfair
Houston 4699066, Texas 4736286 77065
Houston 4699066, Texas 4736286 77065
ACRC Trials (Administrative Site)
Plano 4719457, Texas 4736286 75024
Plano 4719457, Texas 4736286 75024
Virginia Research Center
Midlothian 4772943, Virginia 6254928 23114
Midlothian 4772943, Virginia 6254928 23114
Seattle Children's- Building Cure
Seattle 5809844, Washington 5815135 98101
Seattle 5809844, Washington 5815135 98101
Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Seattle 5809844, Washington 5815135 98105
Clinical Research Puerto Rico
Guayama 4565105, Puerto Rico 00784
Guayama 4565105, Puerto Rico 00784
University of Puerto Rico - Medical Sciences Campus
San Juan 4568127, Puerto Rico 00935
San Juan 4568127, Puerto Rico 00935
More Details
- NCT ID
- NCT05543616
- Status
- Recruiting
- Sponsor
- BioNTech SE