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

NCT ID: NCT05543616

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-23

Study Completion Date

2026-06-16

Brief Summary

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The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in.

* Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in.
* Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
* Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose.
* Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
* Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

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

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

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

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

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

Injection in the muscle at 0- and 8-weeks

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

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

Injection in the muscle at 0- and 8-weeks

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

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

Injection in the muscle, 2 doses 2 months apart

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

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

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

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

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

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

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

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

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

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

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

Injection in the muscle, 1 dose

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

Intervention Type BIOLOGICAL

injection in the muscle

10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule

Injection in the muscle at 0- and 8-weeks

Group Type EXPERIMENTAL

Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose

Intervention Type BIOLOGICAL

Injection in the muscle

Interventions

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Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Injection in the muscle

Intervention Type BIOLOGICAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose

Injection in the muscle

Intervention Type BIOLOGICAL

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose

Injection in the muscle

Intervention Type BIOLOGICAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose

Injection in the muscle

Intervention Type BIOLOGICAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose

Injection in the muscle

Intervention Type BIOLOGICAL

Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose

injection in the muscle

Intervention Type BIOLOGICAL

Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose

Injection in the muscle

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.


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


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


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


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


* 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


* 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


* 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


* 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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

BioNTech SE

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UAB Child Health Research Unit (CHRU)

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

UAB Child Health Research Unit (CHRU)

Birmingham, Alabama, United States

Site Status ACTIVE_NOT_RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, United States

Site Status NOT_YET_RECRUITING

Advanced Research Center Inc.

Anaheim, California, United States

Site Status RECRUITING

Paradigm Clinical Research Centers, Inc

La Mesa, California, United States

Site Status RECRUITING

Hoag Medical Group Foothill Ranch

Lake Forest, California, United States

Site Status NOT_YET_RECRUITING

Kaiser Permanente

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status NOT_YET_RECRUITING

Kaiser Permanente Oakland

Oakland, California, United States

Site Status NOT_YET_RECRUITING

Kaiser Permanente Oakland

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente Oakland

Oakland, California, United States

Site Status ACTIVE_NOT_RECRUITING

Clinical and Translational Research Unit (CTRU) & Spectrum Biobank

Palo Alto, California, United States

Site Status RECRUITING

Center for Clinical Trials, LLC

Paramount, California, United States

Site Status ACTIVE_NOT_RECRUITING

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status ACTIVE_NOT_RECRUITING

Kaiser Permanente Sacramento

Sacramento, California, United States

Site Status NOT_YET_RECRUITING

Kaiser Permanente Sacramento

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente Sacramento

Sacramento, California, United States

Site Status ACTIVE_NOT_RECRUITING

Paradigm Clinical Research, LLC

San Diego, California, United States

Site Status RECRUITING

Kaiser Permanente Santa Clara

Santa Clara, California, United States

Site Status NOT_YET_RECRUITING

Kaiser Permanente Santa Clara

Santa Clara, California, United States

Site Status RECRUITING

Stanford University Medical Center

Stanford, California, United States

Site Status RECRUITING

PediaClinic

Highlands Ranch, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status RECRUITING

Yale University- Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Emerson Clinical Research Institute - Washington - Connecticut Avenue

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status ACTIVE_NOT_RECRUITING

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Meridian Clinical Research, LLC

Washington D.C., District of Columbia, United States

Site Status ACTIVE_NOT_RECRUITING

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Acevedo Clinical Research Associates

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Bio-Medical Research LLC

Miami, Florida, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Accel Research Sites Network- Nona Pediatric Center

Orlando, Florida, United States

Site Status NOT_YET_RECRUITING

SEC Clinical Research

Pensacola, Florida, United States

Site Status RECRUITING

SEC Clinical Research

Pensacola, Florida, United States

Site Status RECRUITING

SEC Clinical Research

Pensacola, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Asclepes Research Center - Spring Hill

Spring Hill, Florida, United States

Site Status NOT_YET_RECRUITING

PAS Research

Tampa, Florida, United States

Site Status NOT_YET_RECRUITING

PAS Research

Tampa, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Children's Center Illness Pod

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Children's Center

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Investigational Drug Service

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status RECRUITING

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Saltzer Health

Nampa, Idaho, United States

Site Status NOT_YET_RECRUITING

The Iowa Clinic, P.C.

Ankeny, Iowa, United States

Site Status RECRUITING

The Iowa Clinic, P.C.

West Des Moines, Iowa, United States

Site Status RECRUITING

The Iowa Clinic

West Des Moines, Iowa, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States

Site Status RECRUITING

Center for Immunization Research Inpatient Unit

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins Center for Immunization Outpatient Clinic

Baltimore, Maryland, United States

Site Status RECRUITING

Boston medical Center (investigational Pharmacy Services, IP delivery)

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

Boston Medical Center Crosstown Building

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

Site Status ACTIVE_NOT_RECRUITING

Velocity Clinical Research, Hastings

Hastings, Nebraska, United States

Site Status ACTIVE_NOT_RECRUITING

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, United States

Site Status ACTIVE_NOT_RECRUITING

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Site Status NOT_YET_RECRUITING

Children's Hospital & Medical Center

Omaha, Nebraska, United States

Site Status ACTIVE_NOT_RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status RECRUITING

Rutgers University

New Brunswick, New Jersey, United States

Site Status RECRUITING

Meridian Clinical Research, LLC

Binghamton, New York, United States

Site Status ACTIVE_NOT_RECRUITING

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

Jacobi Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Senders Pediatrics

Cleveland, Ohio, United States

Site Status RECRUITING

Velocity Clinical Research, Cleveland

Cleveland, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Dayton Clinical Research

Dayton, Ohio, United States

Site Status RECRUITING

PriMED Clinical Research

Dayton, Ohio, United States

Site Status RECRUITING

Cyn3rgy Research

Gresham, Oregon, United States

Site Status RECRUITING

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, United States

Site Status RECRUITING

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

Site Status ACTIVE_NOT_RECRUITING

Coastal Pediatric Research

Charleston, South Carolina, United States

Site Status RECRUITING

Coastal Pediatric Research

Charleston, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Coastal Pediatric Research

Summerville, South Carolina, United States

Site Status RECRUITING

Coastal Pediatric Research

Summerville, South Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

Clinical Research Associates Inc

Nashville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status RECRUITING

Cedar Health Research

Dallas, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Proactive Clinical Research LLC

Edinburg, Texas, United States

Site Status RECRUITING

Proactive Clinical Research, LLC

Edinburg, Texas, United States

Site Status RECRUITING

ACRC TRIALS / Catalyst Physician Group / Frisco Medical Village

Frisco, Texas, United States

Site Status RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

Site Status RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status RECRUITING

DM Clinical Research- Cyfair

Houston, Texas, United States

Site Status RECRUITING

DM Clinical Research

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Dr. Ruben Aleman and Associates

McAllen, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

ACRC Trials (Administrative Site)

Plano, Texas, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Syracuse, Utah, United States

Site Status NOT_YET_RECRUITING

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Virginia Research Center

Midlothian, Virginia, United States

Site Status RECRUITING

Virginia Research Center

Midlothian, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Seattle Children's- Building Cure

Seattle, Washington, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Obras Sociais Irma Dulce

Salvador, Estado de Bahia, Brazil

Site Status ACTIVE_NOT_RECRUITING

Consultoria em Controle de Infecção Hospitalar

Belo Horizonte, Minas Gerais, Brazil

Site Status NOT_YET_RECRUITING

Centro Médico São Francisco

Curitiba, Paraná, Brazil

Site Status NOT_YET_RECRUITING

Centro Médico São Francisco

Curitiba, Paraná, Brazil

Site Status ACTIVE_NOT_RECRUITING

Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN

Natal, Rio Grande do Norte, Brazil

Site Status ACTIVE_NOT_RECRUITING

Hospital de Clínicas de Porto Alegre - Escritório de Projetos e Parcerias Estratégicas

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Clinical Research Puerto Rico

Guayama, , Puerto Rico

Site Status RECRUITING

University of Puerto Rico - Medical Sciences Campus

San Juan, , Puerto Rico

Site Status RECRUITING

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Jaymed Research

Welkom, Free State, South Africa

Site Status ACTIVE_NOT_RECRUITING

REIMED Reiger Park

Boksburg, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Wits RHI

Johannesburg, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

Johannesburg, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Wits VIDA Nkanyezi Research Unit

Johannesburg, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Botho Ke Bontle Health Services

Pretoria, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Sandton Medical Research Centre

Sandton, Gauteng, South Africa

Site Status ACTIVE_NOT_RECRUITING

Gole Biomed Research Centre

Polokwane, Limpopo, South Africa

Site Status ACTIVE_NOT_RECRUITING

Gole Biomed Research Centre

Polokwane, Limpopo, South Africa

Site Status RECRUITING

Merclinco

Middelburg, Mpumalanga, South Africa

Site Status ACTIVE_NOT_RECRUITING

Perinatal HIV Research Unit (PHRU)

Klerksdorp, North West, South Africa

Site Status ACTIVE_NOT_RECRUITING

TREAD Research

Cape Town, Western Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Tsitsikamma Clinical Research Initiative (TCRI)

Plettenberg Bay, Western Cape, South Africa

Site Status ACTIVE_NOT_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil Puerto Rico South Africa

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=C4591048

To obtain contact information for a study center near you, click here.

Other Identifiers

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2024-000001-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-503736-40-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4591048

Identifier Type: -

Identifier Source: org_study_id

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