A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
About this trial
This is an interventional prevention trial for SARS-CoV-2 Virus focused on measuring COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Eligibility Criteria
Substudy A
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.
Sites / Locations
- UAB Child Health Research Unit (CHRU)
- UAB Child Health Research Unit (CHRU)Recruiting
- Phoenix Children's HospitalRecruiting
- Northwest Arkansas Pediatric Clinic
- Paradigm Clinical Research Centers, IncRecruiting
- Kaiser PermanenteRecruiting
- Clinical and Translational Research Unit (CTRU) & Spectrum BiobankRecruiting
- Center for Clinical Trials, LLCRecruiting
- Peninsula Research AssociatesRecruiting
- Stanford University Medical CenterRecruiting
- PediaClinicRecruiting
- Yale University School of MedicineRecruiting
- Yale University School of MedicineRecruiting
- Yale University- Yale Center for Clinical InvestigationRecruiting
- Children's National Medical CenterRecruiting
- Emerson Clinical Research InstituteRecruiting
- Meridian Clinical Research, LLCRecruiting
- Indago Research & Health Center, IncRecruiting
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
- Acevedo Clinical Research AssociatesRecruiting
- Bio-Medical Research LLC
- Clinical Neuroscience Solutions, Inc.Recruiting
- Accel Research Sites Network- Nona Pediatric Center
- SEC Clinical ResearchRecruiting
- SEC Clinical ResearchRecruiting
- Asclepes Research Center - Spring Hill
- PAS Research
- PAS ResearchRecruiting
- Emory University School of MedicineRecruiting
- Emory Children's Center Illness PodRecruiting
- Emory Children's CenterRecruiting
- Emory University School of MedicineRecruiting
- Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
- Saltzer Health
- Alliance for Multispecialty Research, LLCRecruiting
- Alliance for Multispecialty Research, LLCRecruiting
- Louisiana State University Health Sciences ShreveportRecruiting
- Center for Immunization Research Inpatient UnitRecruiting
- Johns Hopkins Center for Immunization Outpatient ClinicRecruiting
- Boston medical Center (investigational Pharmacy Services, IP delivery)Recruiting
- Boston Medical CenterRecruiting
- Meridian Clinical Research, LLCRecruiting
- Velocity Clinical Research, LincolnRecruiting
- Midwest Children's Health Research Institute
- Children's Hospital & Medical CenterRecruiting
- Rutgers Robert Wood Johnson Medical SchoolRecruiting
- Rutgers UniversityRecruiting
- Meridian Clinical Research, LLCRecruiting
- Jacobi Medical Center
- SUNY Downstate Health Sciences UniversityRecruiting
- Rochester Clinical Research, LLCRecruiting
- University of Rochester Medical CenterRecruiting
- Atrium Health - Carolinas Medical CenterRecruiting
- Duke University - Main Hospital and ClinicsRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Senders PediatricsRecruiting
- Velocity Clinical Research, Cleveland
- Centricity Research Columbus Ohio MultispecialtyRecruiting
- PriMED Clinical ResearchRecruiting
- Cyn3rgy ResearchRecruiting
- Allegheny Health and Wellness PavilionRecruiting
- Velocity Clinical Research, ProvidenceRecruiting
- Coastal Pediatric ResearchRecruiting
- Tribe Clinical Research, LLCRecruiting
- Coastal Pediatric ResearchRecruiting
- St. Jude Children's Research HospitalRecruiting
- Clinical Research Associates IncRecruiting
- Driscoll Children's HospitalRecruiting
- Cedar Health ResearchRecruiting
- Proactive Clinical Research, LLCRecruiting
- Village Health Partners - Frisco Medical VillageRecruiting
- University of Texas Medical Branch
- Texas Children's HospitalRecruiting
- DM Clinical ResearchRecruiting
- Dr. Ruben Aleman and AssociatesRecruiting
- ACRC Trials (Administrative Site)Recruiting
- Alliance for Multispecialty Research, LLC
- Pediatric Research of Charlottesville, LLCRecruiting
- Virginia Research CenterRecruiting
- Seattle Children's- Building CureRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Experimental
Experimental
Experimental
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3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule
3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule
Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose
Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose
3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1)
10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Injection in the muscle at 0- and 8-weeks
Injection in the muscle at 0- and 8-weeks
Injection in the muscle, 2 doses 2 months apart
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle at 0-, 3-, and 11-weeks
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose
Injection in the muscle, 1 dose