A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
- Conditions
- SARS-CoV-2 VirusSevere Acute Respiratory Syndrome Coronavirus 2COVID-19
- Interventions
- Biological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram doseBiological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram doseBiological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram doseBiological: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram doseBiological: Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected DoseBiological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram doseBiological: Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
- Registration Number
- NCT05543616
- Lead Sponsor
- BioNTech SE
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3692
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose Injection in the muscle, 1 dose 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Injection in the muscle, 2 doses 2 months apart 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose Injection in the muscle, 1 dose Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose Injection in the muscle at 0- and 8-weeks Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose Injection in the muscle at 0- and 8-weeks 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose Injection in the muscle, 1 dose 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Injection in the muscle, 1 dose 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Injection in the muscle, 1 dose 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle, 1 dose 10 microgram dose, 5 to <12 Years (Substudy D, Group 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle, 1 dose 10 microgram dose, 5 to <12 Years (Substudy D, Group 2) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle, 1 dose 10 microgram dose, 5 to <12 Years (Substudy D, Group 3) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle, 1 dose 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1) Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose Injection in the muscle, 1 dose Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose Injection in the muscle, 1 dose Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose Injection in the muscle, 1 dose 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2) Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose Injection in the muscle, 1 dose
- Primary Outcome Measures
Name Time Method SSA - Ph 2/3 selected dose, percentage of participants reporting local reactions for up to 7 days following Dose 1 (for Groups 1 through 5), Dose 2 (for Groups 1, 2, and 3), 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
SSB - percentage of participants reporting serious adverse events from Dose 1 to 6 months after the last dose as elicited by investigational site staff
SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age 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
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 At baseline (before Dose 1) and 1 month after Dose 1 As measured at the central laboratory
SSD - percentage of participants reporting systemic events for up to 7 days following Dose 1 fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age at 1 month after bivalent BNT162b2 as a fourth dose for participants who received 3 prior doses of BNT162b2 10 µg and at 1 month after a third dose of BNT162b2 10 µg for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 µg As measured at the central laboratory
SSA - Ph 1 dose finding, percentage of participants reporting systemic events 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
SSA - Ph 1 dose finding, percentage of participants reporting adverse events 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
SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events from Dose 1 to 6 months after the last dose as elicited by investigational site staff
SSA - Ph 2/3 selected dose, percentage of participants reporting systemic events for up to 7 days following Dose 1 (for Groups 1 through 5), Dose 2 (for Groups 1, 2, and 3), 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
SSA - Ph 2/3 selected dose, percentage of participants reporting adverse events from Dose 1 to 1 month after the last dose as elicited by investigational site staff
SSA - Ph 2/3 selected dose, percentage of participants reporting serious adverse events from Dose 1 to 6 months after the last dose as elicited by investigational site staff
SSA - Ph 2/3 selected dose, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain in participants ≥2 to <5 years of age At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) at the selected dose 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
SSB - percentage of participants reporting adverse events 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
Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions 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
SSA - Ph 2/3 selected dose, 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 At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) at the selected dose (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
SSA - Ph 2/3 selected dose, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain titers in participants ≥6 months to <2 years of age At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) at the selected dose (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
SSA - Ph 2/3 selected dose, 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 At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) at the selected dose 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
Substudy B (SSB) - percentage of participants reporting local reactions 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
SSB - percentage of participants reporting systemic events 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
SSC - Ph 1 dose finding, percentage of participants reporting adverse events 1 month after Dose 1 as elicited by investigational site staff
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 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
Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions 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
SSC - Ph 1 dose finding, percentage of participants reporting systemic events 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
SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events 6 months after Dose 1 as elicited by investigational site staff
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 At baseline (before Dose 1) and 1 month after Dose 1 As measured at the central laboratory
SSE - percentage of participants reporting adverse events 1 month after Dose 1 as elicited by investigational site staff
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 At baseline (before Dose 1) and 1 month after Dose 1 As measured at the central laboratory
Substudy D (SSD) - percentage of participants reporting local reactions for up to 7 days following Dose 1 pain at the injection site, redness, and swelling as self-reported on electronic diaries
SSD - percentage of participants reporting adverse events 1 month after Dose 1 as elicited by investigational site staff
SSE - percentage of participants reporting systemic events for up to 7 days following Dose 1 fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
SSD - percentage of participants reporting serious adverse events 6 months after Dose 1 as elicited by investigational site staff
SSD - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 10 μg and a fourth dose of bivalent BNT162b2 to those at 1 month after Dose 3 for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 μg As measured at the central laboratory
Substudy E (SSE) - percentage of participants reporting local reactions for up to 7 days following Dose 1 pain at the injection site, redness, and swelling as self-reported on electronic diaries
SSE - percentage of participants reporting serious adverse events 6 months after Dose 1 as elicited by investigational site staff
SSE - noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 reference strain-neutralizing titers in participants ≥5 to <12 years of age At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥5 to <12 years of age to 1 month after Dose 2 in Study C4591007 Phase 2/3 participants who received 2 doses of original BNT162b2 10 microgram As measured at the central laboratory
SSE - noninferiority with respect to seroresponse rate to the reference strain in participants ≥5 to <12 years of age At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥5 to <12 years of age and at 1 month after Dose 2 in Study C4591007 Phase 2/3 participants who received 2 doses of original BNT162b2 10 microgram As measured at the central laboratory
- Secondary Outcome Measures
Name Time Method SSD - geometric mean fold rise elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age At baseline (before Dose 1) and 1 month after Dose 1 As measured at the central laboratory
SSE - geometric mean titers elicited by BNT162b2 (Omicron XBB.1.5) given as a single dose in participants ≥2 to <12 years of age and by original BNT162b2 in Study C4591007 participants ≥2 to <12 years of age At baseline (before Dose 1), 1 month after Dose 1 for participants ≥2 to <12 years who received 1 dose BNT162b2 (Omi XBB.1.5), 1 month after Dose 3 for C4591007 participants ≥2 to <5 years, and 1 month after Dose 2 for C4591007 participants ≥5 to <12 yrs As measured at the central laboratory
SSE - geometric mean fold rise elicited by BNT162b2 (Omicron XBB.1.5) given as a single dose in participants ≥2 to <12 years of age and by original BNT162b2 in Study C4591007 participants ≥2 to <12 years of age At baseline (before Dose 1), 1 month after Dose 1 for participants ≥2 to <12 years who received 1 dose BNT162b2 (Omi XBB.1.5), 1 month after Dose 3 for C4591007 participants ≥2 to <5 years, and 1 month after Dose 2 for C4591007 participants ≥5 to <12 yrs As measured at the central laboratory
SSD - geometric mean titers elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age At baseline (before Dose 1) and 1 month after Dose 1 As measured at the central laboratory
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 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
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 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
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 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
SSA - Ph 2/3 selected dose, 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 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
SSA - Ph 2/3 selected dose, 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 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
SSA - Ph 2/3 selected dose, 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 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
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 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
SSB - noninferiority with respect to seroresponse rate to the reference strain in participants ≥6 months to <5 years of age 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
SSB - geometric mean titers elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age 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
SSB - geometric mean fold rise elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age 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
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 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
SSD - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age At baseline (before Dose 1) and 1 month after Dose 1 As measured at the central laboratory
SSE - percentage of participants with seroresponse elicited by BNT162b2 (Omicron XBB.1.5) given as a single dose in participants ≥2 to <12 years of age and by original BNT162b2 in Study C4591007 participants ≥2 to <12 years of age At baseline (before Dose 1), 1 month after Dose 1 for participants ≥2 to <12 years who received 1 dose BNT162b2 (Omi XBB.1.5), 1 month after Dose 3 for C4591007 participants ≥2 to <5 years, and 1 month after Dose 2 for C4591007 participants ≥5 to <12 yrs As measured at the central laboratory
Trial Locations
- Locations (106)
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Emory Children's Center
🇺🇸Atlanta, Georgia, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Emory Children's Center Illness Pod
🇺🇸Atlanta, Georgia, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Boston Medical Center Crosstown Building
🇺🇸Boston, Massachusetts, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's- Building Cure
🇺🇸Seattle, Washington, United States
Paradigm Clinical Research, LLC
🇺🇸San Diego, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Hospital de Clínicas de Porto Alegre - Escritório de Projetos e Parcerias Estratégicas
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Clinical Research Puerto Rico
🇵🇷Guayama, Puerto Rico
Consultoria em Controle de Infecção Hospitalar
🇧🇷Belo Horizonte, Minas Gerais, Brazil
ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
🇺🇸Frisco, Texas, United States
DM Clinical Research
🇺🇸Houston, Texas, United States
Dr. Ruben Aleman and Associates
🇺🇸McAllen, Texas, United States
Virginia Research Center
🇺🇸Midlothian, Virginia, United States
ACRC Trials (Administrative Site)
🇺🇸Plano, Texas, United States
Obras Sociais Irma Dulce
🇧🇷Salvador, Bahia, Brazil
University of Puerto Rico - Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Wits RHI
🇿🇦Johannesburg, Gauteng, South Africa
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Centro Médico São Francisco
🇧🇷Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
REIMED Reiger Park
🇿🇦Boksburg, Gauteng, South Africa
University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
🇿🇦Johannesburg, Gauteng, South Africa
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Wits VIDA Nkanyezi Research Unit
🇿🇦Johannesburg, Gauteng, South Africa
Newtown Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
Botho Ke Bontle Health Services
🇿🇦Pretoria, Gauteng, South Africa
TREAD Research
🇿🇦Cape Town, Western CAPE, South Africa
Gole Biomed Research Centre
🇿🇦Polokwane, Limpopo, South Africa
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Bio-Medical Research LLC
🇺🇸Miami, Florida, United States
SEC Clinical Research
🇺🇸Pensacola, Florida, United States
Emory University Investigational Drug Service
🇺🇸Atlanta, Georgia, United States
Asclepes Research Center - Spring Hill
🇺🇸Spring Hill, Florida, United States
Saltzer Health
🇺🇸Nampa, Idaho, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Alliance for Multispecialty Research, LLC
🇺🇸Syracuse, Utah, United States
Johns Hopkins Center for Immunization Outpatient Clinic
🇺🇸Baltimore, Maryland, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
Louisiana State University Health Sciences Shreveport
🇺🇸Shreveport, Louisiana, United States
Midwest Children's Health Research Institute
🇺🇸Lincoln, Nebraska, United States
Center for Immunization Research Inpatient Unit
🇺🇸Baltimore, Maryland, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Boston medical Center (investigational Pharmacy Services, IP delivery)
🇺🇸Boston, Massachusetts, United States
Velocity Clinical Research, Lincoln
🇺🇸Lincoln, Nebraska, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Centricity Research Columbus Ohio Multispecialty
🇺🇸Columbus, Ohio, United States
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
SUNY Downstate Health Sciences University
🇺🇸Brooklyn, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Velocity Clinical Research, Cleveland
🇺🇸Cleveland, Ohio, United States
Duke University - Main Hospital and Clinics
🇺🇸Durham, North Carolina, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Atrium Health - Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Senders Pediatrics
🇺🇸Cleveland, Ohio, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
PriMED Clinical Research
🇺🇸Dayton, Ohio, United States
Cedar Health Research
🇺🇸Dallas, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Allegheny Health and Wellness Pavilion
🇺🇸Erie, Pennsylvania, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
UAB Child Health Research Unit (CHRU)
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Sandton Medical Research Centre
🇿🇦Sandton, Gauteng, South Africa
Perinatal HIV Research Unit (PHRU)
🇿🇦Klerksdorp, North-west, South Africa
The Iowa Clinic, P.C.
🇺🇸West Des Moines, Iowa, United States
Proactive Clinical Research, LLC
🇺🇸Edinburg, Texas, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
Advanced Research Center Inc.
🇺🇸Anaheim, California, United States
Paradigm Clinical Research Centers, Inc
🇺🇸La Mesa, California, United States
Hoag Medical Group Foothill Ranch
🇺🇸Lake Forest, California, United States
Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
🇺🇸Palo Alto, California, United States
Kaiser Permanente Oakland
🇺🇸Oakland, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Kaiser Permanente Santa Clara
🇺🇸Santa Clara, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
PediaClinic
🇺🇸Highlands Ranch, Colorado, United States
Emerson Clinical Research Institute - Washington - Connecticut Avenue
🇺🇸Washington, District of Columbia, United States
Meridian Clinical Research, LLC
🇺🇸Binghamton, New York, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Emerson Clinical Research Institute
🇺🇸Washington, District of Columbia, United States
Accel Research Sites Network- Nona Pediatric Center
🇺🇸Orlando, Florida, United States
Yale University- Yale Center for Clinical Investigation
🇺🇸New Haven, Connecticut, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Kaiser Permanente Sacramento
🇺🇸Sacramento, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
PAS Research
🇺🇸Tampa, Florida, United States
Children's Hospital & Medical Center
🇺🇸Omaha, Nebraska, United States
Coastal Pediatric Research
🇺🇸Summerville, South Carolina, United States
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
🇧🇷Natal, RIO Grande DO Norte, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, SÃO Paulo, Brazil
Synergy Biomed Research Institute
🇿🇦East London, Eastern CAPE, South Africa