Clinical trial NCT05543616: A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2022-09-16
Enrollment: 3692
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Substudy A

Inclusion Criteria:

* Phase 1: Healthy male or female participants ≥6 months to \<4 years 3 months of age, at the time of randomization.
* Phase 2/3: Healthy male or female participants ≥6 months to \<5 years of age at the time of randomization/enrollment.

Exclusion Criteria:

* Previous or current diagnosis of multisystem inflammatory syndrome in children (MIS-C).
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy.
* Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
* Any history of myocarditis or pericarditis.
* Previous vaccination with any COVID-19 vaccine.
* Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.

Substudy B

Inclusion Criteria:

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

Exclusion Criteria:

* Previous or current diagnosis of MIS-C.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy.
* Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus.
* Prior receipt of any COVID 19 vaccine other than BNT162b2.
* Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.

Substudy C

Inclusion Criteria:

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

Exclusion Criteria:

* Previous or current diagnosis of MIS-C.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy.
* Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus.
* Prior receipt of any COVID 19 vaccine other than BNT162b2.
* Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.

Substudy D

Inclusion Criteria:

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

Exclusion Criteria:

* Previous or current diagnosis of MIS-C.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy.
* Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus.
* Female who is pregnant or breastfeeding.
* Prior receipt of any COVID 19 vaccine other than BNT162b2.
* Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. Systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh \>10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.

Substudy E

Inclusion Criteria:

- Healthy male or female participants ≥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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events
timeFrame: from Dose 1 to 6 months after the last dose
measure: SSA - Ph 2/3 selected dose, percentage of participants reporting local reactions
timeFrame: 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)
measure: SSA - Ph 2/3 selected dose, percentage of participants reporting systemic events
timeFrame: 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)
measure: SSA - Ph 2/3 selected dose, percentage of participants reporting adverse events
timeFrame: from Dose 1 to 1 month after the last dose
measure: SSA - Ph 2/3 selected dose, percentage of participants reporting serious adverse events
timeFrame: from Dose 1 to 6 months after the last dose
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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)
measure: 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)
measure: 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)
measure: SSB - percentage of participants reporting serious adverse events
timeFrame: from Dose 1 to 6 months after the last dose
measure: 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
measure: 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
measure: Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions
timeFrame: for up to 7 days following Dose 1
measure: SSC - Ph 1 dose finding, percentage of participants reporting systemic events
timeFrame: for up to 7 days following Dose 1
measure: SSC - Ph 1 dose finding, percentage of participants reporting adverse events
timeFrame: 1 month after Dose 1
measure: SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events
timeFrame: 6 months after Dose 1
measure: 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
measure: 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
measure: 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
measure: Substudy D (SSD) - percentage of participants reporting local reactions
timeFrame: for up to 7 days following Dose 1
measure: SSD - percentage of participants reporting systemic events
timeFrame: for up to 7 days following Dose 1
measure: SSD - percentage of participants reporting adverse events
timeFrame: 1 month after Dose 1
measure: SSD - percentage of participants reporting serious adverse events
timeFrame: 6 months after Dose 1
measure: 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
timeFrame: 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
measure: SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age
timeFrame: 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
measure: Substudy E (SSE) - percentage of participants reporting local reactions
timeFrame: for up to 7 days following Dose 1
measure: SSE - percentage of participants reporting systemic events
timeFrame: for up to 7 days following Dose 1
measure: SSE - percentage of participants reporting adverse events
timeFrame: 1 month after Dose 1
measure: SSE - percentage of participants reporting serious adverse events
timeFrame: 6 months after Dose 1
measure: 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
timeFrame: 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
measure: SSE - noninferiority with respect to seroresponse rate to the reference strain in participants ≥5 to <12 years of age
timeFrame: 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
Secondary outcomes:
measure: 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
measure: 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, 1 month after Dose 3, and 1 month after Dose 4
measure: 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, 1 month after Dose 3, and 1 month after Dose 4
measure: 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
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)
measure: 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
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)
measure: 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
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)
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Child Health Research Unit (CHRU)
state: Alabama
city: Birmingham
country: United States
facility: UAB Child Health Research Unit (CHRU)
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center Inc.
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc
state: California
city: Lake Forest
country: United States
facility: Hoag Medical Group Foothill Ranch
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Palo Alto
country: United States
facility: Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: San Diego
country: United States
facility: Paradigm Clinical Research, LLC
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Highlands Ranch
country: United States
facility: PediaClinic
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale University- Yale Center for Clinical Investigation
state: Connecticut
city: Washington
country: United States
facility: Emerson Clinical Research Institute - Washington - Connecticut Avenue
state: District of Columbia
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Washington
country: United States
facility: Meridian Clinical Research, LLC
state: District of Columbia
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites Network- Nona Pediatric Center
state: Florida
city: Pensacola
country: United States
facility: SEC Clinical Research
state: Florida
city: Pensacola
country: United States
facility: SEC Clinical Research
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Center - Spring Hill
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center Illness Pod
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Investigational Drug Service
state: Georgia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Nampa
country: United States
facility: Saltzer Health
state: Idaho
city: Ankeny
country: United States
facility: The Iowa Clinic, P.C.
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic, P.C.
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Center for Immunization Research Inpatient Unit
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Center for Immunization Outpatient Clinic
state: Maryland
city: Boston
country: United States
facility: Boston medical Center (investigational Pharmacy Services, IP delivery)
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center Crosstown Building
state: Massachusetts
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Hastings
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research, Lincoln
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health - Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University - Main Hospital and Clinics
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Senders Pediatrics
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research, LLC
state: Texas
city: Frisco
country: United States
facility: ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: McAllen
country: United States
facility: Dr. Ruben Aleman and Associates
state: Texas
city: Plano
country: United States
facility: ACRC Trials (Administrative Site)
state: Texas
city: Syracuse
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's- Building Cure
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Salvador
country: Brazil
facility: Obras Sociais Irma Dulce
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Consultoria em Controle de Infecção Hospitalar
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Centro Médico São Francisco
state: Paraná
city: Curitiba
country: Brazil
facility: Centro Médico São Francisco
state: Paraná
city: Natal
country: Brazil
facility: Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
state: RIO Grande DO Norte
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre - Escritório de Projetos e Parcerias Estratégicas
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RIO Grande DO SUL
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: SÃO Paulo
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Guayama
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico - Medical Sciences Campus
city: East London
country: South Africa
facility: Synergy Biomed Research Institute
state: Eastern CAPE
city: Boksburg
country: South Africa
facility: REIMED Reiger Park
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits RHI
state: Gauteng
city: Johannesburg
country: South Africa
facility: University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits VIDA Nkanyezi Research Unit
state: Gauteng
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho Ke Bontle Health Services
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Medical Research Centre
state: Gauteng
city: Polokwane
country: South Africa
facility: Gole Biomed Research Centre
state: Limpopo
city: Klerksdorp
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
state: North-west
city: Cape Town
country: South Africa
facility: TREAD Research
state: Western CAPE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: