©2024 Stanford Medicine
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
Recruiting
Trial ID: NCT05543616
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.
Official Title
A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDREN
Stanford Investigator(s)
Eligibility
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.
Intervention(s):
biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
biological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305