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

Trial status:Recruiting
Trial ID:
C4591048
NCT ID:
NCT05543616
EudraCT ID:
2024-000001-33
EU Trial (CTIS) Number:
2023-503736-40-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

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.
Medical Condition
  • COVID-19
    • Trial Drug
  • Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
    • See more
  • Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
  • Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
  • Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
  • Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
  • Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
  • Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose
    • Phase
    Phase 2/Phase 3
    Type
    Interventional
    Estimated Enrolment
    4292
    Estimated Trial Date
    Sep 2022 - Jun 2026

    Trial Participant Requirements

    Age
    6 Months - 11 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion 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 ≥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.

    Trial Locations

    Location
    Status
    Location
    UAB Child Health Research Unit (CHRU)
    Birmingham, Alabama, United States, 35233
    Status
    Not yet recruiting
    Location
    Phoenix Children's Hospital
    Phoenix, Arizona, United States, 85016
    Status
    Active, not recruiting
    Location
    Northwest Arkansas Pediatric Clinic
    Fayetteville, Arkansas, United States, 72703
    Status
    Not yet recruiting
    Location
    Advanced Research Center Inc.
    Anaheim, California, United States, 92805
    Status
    Recruiting
    Location
    Paradigm Clinical Research Centers, Inc
    La Mesa, California, United States, 91942
    Status
    Recruiting
    Location
    Hoag Medical Group Foothill Ranch
    Lake Forest, California, United States, 92610
    Status
    Not yet recruiting
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