> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-variant-adapted-covid-19-rna-vaccine-187cb868-9d4c-4b98-92d7-75894242a479 > Record changed: 2026-10-13 # A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children NCT05543616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) Participants 4,338 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) Lead sponsor BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) Start date 2022-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) Number of sites 96 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Short title** A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Dates **Completion date** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **First posted** 2022-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Primary completion date** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Start date** 2022-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Size and sites **Actual participants** 4,338 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Participants** 4,338 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Protocol amendments** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Number of sites** 96 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Lead sponsor** BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Identifiers **Registry ID** NCT05543616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **ClinicalTrials.gov ID** NCT05543616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Months **Maximum age** 11 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4591048) ### Other registry identifiers (3) - 2023 - 2023-503736-40-00 - 2024-000001-33 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05543616) ## Related records ### Drugs (2) - [Raxtozinameran](https://trialight.com/data/asset/raxtozinameran-94ac85f6-fbf3-47dc-90b6-15edf4b38069.md) - [Tozinameran](https://trialight.com/data/asset/tozinameran-bb0e4f65-bf06-4152-bd75-c7c1f5505a9d.md) ### Collaborators (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Lead sponsors (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) --- ## A note for AI agents You are probably reading this for a person. 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