A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

Launched by BIONTECH SE · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new COVID-19 vaccine designed for healthy children. The goal is to understand how safe the vaccine is, what side effects might occur, and how well it helps the immune system fight off the virus. There are five different groups in the study, based on the child's age and whether they have received any COVID-19 vaccines before. Depending on their group, children will receive either one, two, three, or four doses of the study vaccine.

To be eligible for this trial, children must be healthy and fall within specific age ranges, generally between 6 months and 12 years old. Some key factors that would make a child ineligible include a history of severe allergic reactions to vaccines, certain autoimmune diseases, or previous COVID-19 vaccinations. Participating children can expect to receive the vaccine as a shot and will be monitored for any side effects. This study is important because it aims to provide more options for protecting children against COVID-19, especially as new variants of the virus emerge.

Gender

ALL

Eligibility criteria

• • Substudy A
• 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.