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

Primary Purpose

SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
Sponsored by
BioNTech SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 Virus focused on measuring COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine

Eligibility Criteria

6 Months - 11 Years (Child)All SexesAccepts Healthy Volunteers

Substudy A

Inclusion Criteria:

- Healthy male or female participants ≥6 months to <4 years 3 months of age, at the time of randomization.

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.
  • 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:

- Health 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.

Sites / Locations

  • UAB Child Health Research Unit (CHRU)
  • UAB Child Health Research Unit (CHRU)Recruiting
  • Phoenix Children's HospitalRecruiting
  • Northwest Arkansas Pediatric Clinic
  • Paradigm Clinical Research Centers, IncRecruiting
  • Kaiser PermanenteRecruiting
  • Clinical and Translational Research Unit (CTRU) & Spectrum BiobankRecruiting
  • Center for Clinical Trials, LLCRecruiting
  • Peninsula Research AssociatesRecruiting
  • Stanford University Medical CenterRecruiting
  • PediaClinicRecruiting
  • Yale University School of MedicineRecruiting
  • Yale University School of MedicineRecruiting
  • Yale University- Yale Center for Clinical InvestigationRecruiting
  • Children's National Medical CenterRecruiting
  • Emerson Clinical Research InstituteRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Indago Research & Health Center, IncRecruiting
  • Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
  • Acevedo Clinical Research AssociatesRecruiting
  • Bio-Medical Research LLC
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Accel Research Sites Network- Nona Pediatric Center
  • SEC Clinical ResearchRecruiting
  • SEC Clinical ResearchRecruiting
  • Asclepes Research Center - Spring Hill
  • PAS Research
  • PAS ResearchRecruiting
  • Emory University School of MedicineRecruiting
  • Emory Children's Center Illness PodRecruiting
  • Emory Children's CenterRecruiting
  • Emory University School of MedicineRecruiting
  • Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
  • Saltzer Health
  • Alliance for Multispecialty Research, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Louisiana State University Health Sciences ShreveportRecruiting
  • Center for Immunization Research Inpatient UnitRecruiting
  • Johns Hopkins Center for Immunization Outpatient ClinicRecruiting
  • Boston medical Center (investigational Pharmacy Services, IP delivery)Recruiting
  • Boston Medical CenterRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Velocity Clinical Research, LincolnRecruiting
  • Midwest Children's Health Research Institute
  • Children's Hospital & Medical CenterRecruiting
  • Rutgers Robert Wood Johnson Medical SchoolRecruiting
  • Rutgers UniversityRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Jacobi Medical Center
  • SUNY Downstate Health Sciences UniversityRecruiting
  • Rochester Clinical Research, LLCRecruiting
  • University of Rochester Medical CenterRecruiting
  • Atrium Health - Carolinas Medical CenterRecruiting
  • Duke University - Main Hospital and ClinicsRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Senders PediatricsRecruiting
  • Velocity Clinical Research, Cleveland
  • Centricity Research Columbus Ohio MultispecialtyRecruiting
  • PriMED Clinical ResearchRecruiting
  • Cyn3rgy ResearchRecruiting
  • Allegheny Health and Wellness PavilionRecruiting
  • Velocity Clinical Research, ProvidenceRecruiting
  • Coastal Pediatric ResearchRecruiting
  • Tribe Clinical Research, LLCRecruiting
  • Coastal Pediatric ResearchRecruiting
  • St. Jude Children's Research HospitalRecruiting
  • Clinical Research Associates IncRecruiting
  • Driscoll Children's HospitalRecruiting
  • Cedar Health ResearchRecruiting
  • Proactive Clinical Research, LLCRecruiting
  • Village Health Partners - Frisco Medical VillageRecruiting
  • University of Texas Medical Branch
  • Texas Children's HospitalRecruiting
  • DM Clinical ResearchRecruiting
  • Dr. Ruben Aleman and AssociatesRecruiting
  • ACRC Trials (Administrative Site)Recruiting
  • Alliance for Multispecialty Research, LLC
  • Pediatric Research of Charlottesville, LLCRecruiting
  • Virginia Research CenterRecruiting
  • Seattle Children's- Building CureRecruiting
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)

Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule

Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule

3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)

3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)

3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)

6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)

10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)

10 microgram dose, 5 to <12 Years (Substudy D, Group 1)

10 microgram dose, 5 to <12 Years (Substudy D, Group 2)

10 microgram dose, 5 to <12 Years (Substudy D, Group 3)

3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)

6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)

10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)

3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule

Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose

Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose

3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1)

10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)

Arm Description

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Injection in the muscle at 0- and 8-weeks

Injection in the muscle at 0- and 8-weeks

Injection in the muscle, 2 doses 2 months apart

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle at 0-, 3-, and 11-weeks

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Injection in the muscle, 1 dose

Outcomes

Primary Outcome Measures

Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions
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 1 dose finding, percentage of participants reporting systemic events
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
as elicited by investigational site staff
SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events
as elicited by investigational site staff
SSA - Ph 2/3 selected dose, percentage of participants reporting local reactions
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, percentage of participants reporting systemic events
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
as elicited by investigational site staff
SSA - Ph 2/3 selected dose, percentage of participants reporting serious adverse events
as elicited by investigational site staff
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
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
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
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 in participants ≥2 to <5 years of age
As measured at the central laboratory
Substudy B (SSB) - percentage of participants reporting local reactions
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
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
SSB - percentage of participants reporting adverse events
as elicited by investigational site staff
SSB - percentage of participants reporting serious adverse events
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
As measured at the central laboratory
SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age
As measured at the central laboratory
Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions
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
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
as elicited by investigational site staff
SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events
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
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
As measured at the central laboratory
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
As measured at the central laboratory
Substudy D (SSD) - percentage of participants reporting local reactions
pain at the injection site, redness, and swelling as self-reported on electronic diaries
SSD - percentage of participants reporting systemic events
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 adverse events
as elicited by investigational site staff
SSD - percentage of participants reporting serious adverse events
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
As measured at the central laboratory
SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age
As measured at the central laboratory
Substudy E (SSE) - percentage of participants reporting local reactions
pain at the injection site, redness, and swelling as self-reported on electronic diaries
SSE - percentage of participants reporting systemic events
fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
SSE - percentage of participants reporting adverse events
as elicited by investigational site staff
SSE - percentage of participants reporting serious adverse events
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
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
As measured at the central laboratory

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
As measured at the central laboratory
SSD - geometric mean fold rise elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age
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
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
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
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
As measured at the central laboratory

Full Information

First Posted
September 14, 2022
Last Updated
October 18, 2023
Sponsor
BioNTech SE
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05543616
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
June 2, 2025 (Anticipated)
Study Completion Date
June 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNTech SE
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
Keywords
COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
3692 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Arm Title
6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Arm Title
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Arm Title
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule
Arm Type
Experimental
Arm Description
Injection in the muscle at 0- and 8-weeks
Arm Title
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule
Arm Type
Experimental
Arm Description
Injection in the muscle at 0- and 8-weeks
Arm Title
3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 2 doses 2 months apart
Arm Title
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Arm Title
6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Arm Title
10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3
Arm Title
6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule
Arm Type
Experimental
Arm Description
Injection in the muscle at 0-, 3-, and 11-weeks
Arm Title
Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
Selected dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Arm Title
10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2)
Arm Type
Experimental
Arm Description
Injection in the muscle, 1 dose
Intervention Type
Biological
Intervention Name(s)
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose
Intervention Description
Injection in the muscle
Intervention Type
Biological
Intervention Name(s)
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose
Intervention Description
Injection in the muscle
Intervention Type
Biological
Intervention Name(s)
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
Intervention Description
Injection in the muscle
Intervention Type
Biological
Intervention Name(s)
Variant-adapted BNT162b2 (Omicron XBB.1.5) Substudy A Ph 2/3 Selected Dose
Intervention Description
Injection in the muscle
Intervention Type
Biological
Intervention Name(s)
Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose
Intervention Description
Injection in the muscle
Intervention Type
Biological
Intervention Name(s)
Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose
Intervention Description
Injection in the muscle
Intervention Type
Biological
Intervention Name(s)
Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose
Intervention Description
injection in the muscle
Primary Outcome Measure Information:
Title
Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions
Description
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
Time Frame
for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4
Title
SSA - Ph 1 dose finding, percentage of participants reporting systemic events
Description
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
Time Frame
for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4
Title
SSA - Ph 1 dose finding, percentage of participants reporting adverse events
Description
as elicited by investigational site staff
Time Frame
from Dose 1 to 1 month after Dose 3 and from Dose 4 to 1 month after Dose 4
Title
SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events
Description
as elicited by investigational site staff
Time Frame
from Dose 1 to 6 months after the last dose
Title
SSA - Ph 2/3 selected dose, percentage of participants reporting local reactions
Description
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
Time Frame
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)
Title
SSA - Ph 2/3 selected dose, percentage of participants reporting systemic events
Description
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
Time Frame
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)
Title
SSA - Ph 2/3 selected dose, percentage of participants reporting adverse events
Description
as elicited by investigational site staff
Time Frame
from Dose 1 to 1 month after the last dose
Title
SSA - Ph 2/3 selected dose, percentage of participants reporting serious adverse events
Description
as elicited by investigational site staff
Time Frame
from Dose 1 to 6 months after the last dose
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
Substudy B (SSB) - percentage of participants reporting local reactions
Description
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
Time Frame
for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)
Title
SSB - percentage of participants reporting systemic events
Description
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
Time Frame
for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)
Title
SSB - percentage of participants reporting adverse events
Description
as elicited by investigational site staff
Time Frame
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)
Title
SSB - percentage of participants reporting serious adverse events
Description
as elicited by investigational site staff
Time Frame
from Dose 1 to 6 months after the last dose
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age
Description
As measured at the central laboratory
Time Frame
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
Title
Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions
Description
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
Time Frame
for up to 7 days following Dose 1
Title
SSC - Ph 1 dose finding, percentage of participants reporting systemic events
Description
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
Time Frame
for up to 7 days following Dose 1
Title
SSC - Ph 1 dose finding, percentage of participants reporting adverse events
Description
as elicited by investigational site staff
Time Frame
1 month after Dose 1
Title
SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events
Description
as elicited by investigational site staff
Time Frame
6 months after Dose 1
Title
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
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1) and 1 month after Dose 1
Title
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
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1) and 1 month after Dose 1
Title
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
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1) and 1 month after Dose 1
Title
Substudy D (SSD) - percentage of participants reporting local reactions
Description
pain at the injection site, redness, and swelling as self-reported on electronic diaries
Time Frame
for up to 7 days following Dose 1
Title
SSD - percentage of participants reporting systemic events
Description
fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
Time Frame
for up to 7 days following Dose 1
Title
SSD - percentage of participants reporting adverse events
Description
as elicited by investigational site staff
Time Frame
1 month after Dose 1
Title
SSD - percentage of participants reporting serious adverse events
Description
as elicited by investigational site staff
Time Frame
6 months after Dose 1
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age
Description
As measured at the central laboratory
Time Frame
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
Title
Substudy E (SSE) - percentage of participants reporting local reactions
Description
pain at the injection site, redness, and swelling as self-reported on electronic diaries
Time Frame
for up to 7 days following Dose 1
Title
SSE - percentage of participants reporting systemic events
Description
fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries
Time Frame
for up to 7 days following Dose 1
Title
SSE - percentage of participants reporting adverse events
Description
as elicited by investigational site staff
Time Frame
1 month after Dose 1
Title
SSE - percentage of participants reporting serious adverse events
Description
as elicited by investigational site staff
Time Frame
6 months after Dose 1
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
SSE - noninferiority with respect to seroresponse rate to the reference strain in participants ≥5 to <12 years of age
Description
As measured at the central laboratory
Time Frame
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 Outcome Measure Information:
Title
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
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1), 1 month after Dose 2, 1 month after Dose 3, and 1 month after Dose 4
Title
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
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1), 1 month after Dose 2, 1 month after Dose 3, and 1 month after Dose 4
Title
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
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1), 1 month after Dose 2, 1 month after Dose 3, and 1 month after Dose 4
Title
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
Description
As measured at the central laboratory
Time Frame
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)
Title
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
Description
As measured at the central laboratory
Time Frame
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)
Title
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
Description
As measured at the central laboratory
Time Frame
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)
Title
SSB - geometric mean titers elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age
Description
As measured at the central laboratory
Time Frame
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
Title
SSB - geometric mean fold rise elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
SSB - noninferiority with respect to seroresponse rate to the reference strain in participants ≥6 months to <5 years of age
Description
As measured at the central laboratory
Time Frame
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
Title
SSD - geometric mean titers elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1) and 1 month after Dose 1
Title
SSD - geometric mean fold rise elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1) and 1 month after Dose 1
Title
SSD - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as a fourth dose in participants ≥5 to <12 years of age
Description
As measured at the central laboratory
Time Frame
At baseline (before Dose 1) and 1 month after Dose 1
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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
Title
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
Description
As measured at the central laboratory
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UAB Child Health Research Unit (CHRU)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UAB Child Health Research Unit (CHRU)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Arkansas Pediatric Clinic
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Paradigm Clinical Research Centers, Inc
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical and Translational Research Unit (CTRU) & Spectrum Biobank
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Individual Site Status
Recruiting
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
PediaClinic
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80126
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University- Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Emerson Clinical Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Individual Site Status
Recruiting
Facility Name
Bio-Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites Network- Nona Pediatric Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
SEC Clinical Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Individual Site Status
Recruiting
Facility Name
SEC Clinical Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
Asclepes Research Center - Spring Hill
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
PAS Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
PAS Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Children's Center Illness Pod
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Individual Site Status
Recruiting
Facility Name
Saltzer Health
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana State University Health Sciences Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Immunization Research Inpatient Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Center for Immunization Outpatient Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston medical Center (investigational Pharmacy Services, IP delivery)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68522
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital & Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Individual Site Status
Recruiting
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
SUNY Downstate Health Sciences University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Clinical Research, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Atrium Health - Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University - Main Hospital and Clinics
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Senders Pediatrics
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Centricity Research Columbus Ohio Multispecialty
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
PriMED Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Individual Site Status
Recruiting
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Associates Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Health Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Recruiting
Facility Name
Proactive Clinical Research, LLC
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Name
Village Health Partners - Frisco Medical Village
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Ruben Aleman and Associates
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Individual Site Status
Recruiting
Facility Name
ACRC Trials (Administrative Site)
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Research Center
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's- Building Cure
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4591048
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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