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

NCT05543616
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
4,338
clinicaltrials.gov
Lead sponsor
BioNTech SE
clinicaltrials.gov
Start date
2022-09-23
clinicaltrials.gov
Number of sites
96
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Short title
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2026-07-10
clinicaltrials.gov
First posted
2022-09-16
clinicaltrials.gov
Registry last updated
2026-08-06
clinicaltrials.gov
Primary completion date
2026-07-10
clinicaltrials.gov
Start date
2022-09-23
clinicaltrials.gov

Actual participants
4,338
clinicaltrials.gov
Participants
4,338
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
11
clinicaltrials.gov
Number of sites
96
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
BioNTech SE
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05543616
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05543616
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions

    Timeframe: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4

    Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  2. SSA - Ph 1 dose finding, percentage of participants reporting systemic events

    Timeframe: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4

    Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  3. SSA - Ph 1 dose finding, percentage of participants reporting adverse events

    Timeframe: from Dose 1 to 1 month after Dose 3 and from Dose 4 to 1 month after Dose 4

    as elicited by investigational site staff

  4. SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events

    Timeframe: from Dose 1 to 6 months after the last dose

    as elicited by investigational site staff

  5. SSA - Ph 2/3, percentage of participants reporting local reactions

    Timeframe: for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)

    Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  6. SSA - Ph 2/3, percentage of participants reporting systemic events

    Timeframe: for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)

    Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  7. SSA - Ph 2/3, percentage of participants reporting adverse events

    Timeframe: from Dose 1 to 1 month after the last dose

    as elicited by investigational site staff

  8. SSA - Ph 2/3, percentage of participants reporting serious adverse events

    Timeframe: from Dose 1 to 6 months after the last dose

    as elicited by investigational site staff

  9. SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥6 months to <2 years of age

    Timeframe: At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) to 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram

    As measured at the central laboratory

  10. SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain titers in participants ≥6 months to <2 years of age

    Timeframe: At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) and at 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram

    As measured at the central laboratory

  11. SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥2 to <5 years of age

    Timeframe: At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age to 1 month after 3 doses (on a 0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age

    As measured at the central laboratory

  12. SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain in participants ≥2 to <5 years of age

    Timeframe: At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age and at 1 month after 3 doses (0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age

    As measured at the central laboratory

  13. Substudy B (SSB) - percentage of participants reporting local reactions

    Timeframe: for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)

    Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  14. SSB - percentage of participants reporting systemic events

    Timeframe: for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)

    Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  15. SSB - percentage of participants reporting adverse events

    Timeframe: from the first study vaccination to 1 month after the first study vaccination (for Groups 1, 2, and 3), and from the second study vaccination to 1 month after the second study vaccination (for Group 1 only)

    as elicited by investigational site staff

  16. SSB - percentage of participants reporting serious adverse events

    Timeframe: from Dose 1 to 6 months after the last dose

    as elicited by investigational site staff

  17. SSB - superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age

    Timeframe: at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

    As measured at the central laboratory

  18. SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age

    Timeframe: at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

    As measured at the central laboratory

  19. Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions

    Timeframe: for up to 7 days following Dose 1

    Participants ≥6 months to \<2 years of age: tenderness at the injection site, redness, and swelling as self-reported on electronic diaries Participants ≥2 to \<5 years of age: pain at the injection site, redness, and swelling as self-reported on electronic diaries

  20. SSC - Ph 1 dose finding, percentage of participants reporting systemic events

    Timeframe: for up to 7 days following Dose 1

    Participants ≥6 months to \<2 years of age: fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries Participants ≥2 to \<5 years of age: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries

  21. SSC - Ph 1 dose finding, percentage of participants reporting adverse events

    Timeframe: 1 month after Dose 1

    as elicited by investigational site staff

  22. SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events

    Timeframe: 6 months after Dose 1

    as elicited by investigational site staff

  23. SSC - Ph 1 dose finding - geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  24. SSC - Ph 1 dose finding - geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  25. SSC - Ph 1 dose finding - percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

And 12 more, listed on the interactive page.

  1. SSA - Ph 1 dose finding, geometric mean titers elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1), 1 month after Dose 2, 1 month after Dose 3, and 1 month after Dose 4

    As measured at the central laboratory

  2. SSA - Ph 1 dose finding, geometric mean fold rise elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant vaccine type (if applicable) in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

    As measured at the central laboratory

  3. SSA - Ph 1 dose finding, percentage of participants with seroresponse elicited by prophylactic variant-adapted BNT162b2 at each dose level and variant-adapted vaccine type in COVID-19 vaccine-naïve participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3

    As measured at the central laboratory

  4. SSA - Ph 2/3, geometric mean titers elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine-naive participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

    As measured at the central laboratory

  5. SSA - Ph 2/3, geometric mean fold rise elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine naive participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

    As measured at the central laboratory

  6. SSA - Ph 2/3, percentages of participants with seroresponse elicited by variant-adapted BNT162b2 (Omicron XBB.1.5) in COVID-19 vaccine-naive participants ≥6 months to <5 years of age

    Timeframe: At baseline (before Dose 1), 1 month after Dose 1 (Groups 2 and 4), 1 month after Dose 2 (Group 1), and 1 month after Dose 3 (Group 3)

    As measured at the central laboratory

  7. SSB - geometric mean titers elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age

    Timeframe: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  8. SSB - geometric mean fold rise elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age

    Timeframe: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  9. SSB - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age

    Timeframe: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  10. SSB - noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 reference strain-neutralizing titers in participants ≥6 months to <5 years of age

    Timeframe: at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

    As measured at the central laboratory

  11. SSB - noninferiority with respect to seroresponse rate to the reference strain in participants ≥6 months to <5 years of age

    Timeframe: at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg

    As measured at the central laboratory

  12. SSD - geometric mean titers elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  13. SSD - geometric mean fold rise elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  14. SSD - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  15. SSE - geometric mean titers elicited by BNT162b2 (Omicron XBB.1.5) given as a single 10 microgram dose in participants ≥5 to <12 years of age and as a single 30 microgram dose in Study C4591054 Substudy A participants ≥12 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  16. SSE - geometric mean fold rise elicited by BNT162b2 (Omicron XBB.1.5) given as a single 10 microgram dose in participants ≥5 to <12 years of age and as a single 30 microgram dose in Study C4591054 Substudy A participants ≥12 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

  17. SSE - percentage of participants with seroresponse elicited by BNT162b2 (Omicron XBB.1.5) given as a single 10 microgram dose in participants ≥5 to <12 years of age and as a single 30 mcg dose in Study C4591054 Substudy A participants ≥12 years of age

    Timeframe: At baseline (before Dose 1) and 1 month after Dose 1

    As measured at the central laboratory

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
6 Months
Maximum age
11 Years
Healthy volunteers
Yes

Substudy A

  • 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.

  • 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

- Healthy male or female participants = ≥6 months to <5 years of age, at the time of enrollment.

  • 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

- Healthy male or female participants ≥6 months to <5 years of age, at the time of randomization/enrollment.

  • 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

- Healthy male or female participants ≥5 years to <12 years of age, at the time of enrollment.

  • 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

- Healthy male or female participants ≥5 years to <12 years of age, at the time of enrollment.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • UAB Child Health Research Unit (CHRU)Birmingham, United States
  • Phoenix Children's HospitalPhoenix, United States
  • Advanced Research Center Inc.Anaheim, United States
  • Kaiser PermanenteLos Angeles, United States
  • Kaiser Permanente OaklandOakland, United States
  • Stanford University Medical CenterPalo Alto, United States
  • Center for Clinical Trials, LLCParamount, United States
  • Peninsula Research AssociatesRolling Hills Estates, United States
  • Kaiser Permanente SacramentoSacramento, United States
  • PediaClinicHighlands Ranch, United States
  • Yale University School of MedicineNew Haven, United States
  • Yale University- Yale Center for Clinical InvestigationNew Haven, United States
  • Emerson Clinical Research InstituteWashington D.C., United States
  • Children's National Medical CenterWashington D.C., United States
  • Velocity Clinical Research, Washington DCWashington D.C., United States
  • Indago Research & Health Center, IncHialeah, United States
  • Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonville, United States
  • Acevedo Clinical Research AssociatesMiami, United States
  • Bio-Medical Research LLCMiami, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • SEC Clinical ResearchPensacola, United States
  • PAS ResearchTampa, United States
  • Emory Children's Center Illness PODAtlanta, United States
  • Emory University School of MedicineAtlanta, United States
  • Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United States

And 71 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-503736-40-00
  • 2024-000001-33
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)