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
| 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 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 |
|
|
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 |
|
|
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 Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose |
Injection in the muscle, 1 dose |
|
|
Experimental Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose |
Injection in the muscle, 1 dose |
|
|
Experimental 3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1) |
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 |
|
Recruiting Locations
University of Texas Medical Branch
Galveston, Texas 77555
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- BioNTech SE