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NCT04816643

PHASE3

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.

Official title: A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN

Key Details

Gender

All

Age Range

6 Months - 15 Years

Study Type

INTERVENTIONAL

Enrollment

11837

Start Date

2021-03-24

Completion Date

2023-12-08

Last Updated

2026-05-28

Healthy Volunteers

Yes

Conditions

SARS-CoV-2 Infection, COVID-19

Interventions

BIOLOGICAL

Biological/Vaccine: BNT162b2 10mcg

BNT162b2 Low/Mid-Dose (10mcg) level

BIOLOGICAL

BNT162b2 20mcg

BNT162b2 Mid-Dose (20mcg) level

BIOLOGICAL

BNT162b2 30mcg

BNT162b2 High-Dose (30mcg) level

OTHER

Placebo

Intramuscular injection

BIOLOGICAL

Biological/Vaccine: BNT162b2 3mcg

BNT162b2 Low-Dose (3mcg) level

Inclusion Criteria 1. Male or female participants ≥6 months to \<12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and \<16 years of age. 2. Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 4. Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation. 5. Negative urine pregnancy test for female participants who are biologically capable of having children. 6. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children. 7. The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written). Exclusion Criteria 1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19. 2. Phase 1 only: Known infection with HIV, HCV, or HBV. 3. Receipt of medications intended to prevent COVID-19. 4. Previous or current diagnosis of MIS-C. 5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results 6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 8. 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. 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 10. Female who is pregnant or breastfeeding. 11. Previous vaccination with any coronavirus vaccine. 12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, 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. 14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 15. Previous participation in other studies involving study intervention containing LNPs. 16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Locations (128)

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

SCPMG/Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Matrix Clinical Research

Los Angeles, California, United States

Madera Family Medical Group

Madera, California, United States

Kaiser Permanente Oakland

Oakland, California, United States

Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University

Palo Alto, California, United States

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Center for Clinical Trials, LLC

Paramount, California, United States

Center for Clinical Trials

Paramount, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Kaiser Permanente Sacramento

Sacramento, California, United States

Kaiser Permanente Santa Clara

Santa Clara, California, United States

Stanford Health Care Investigational Drug Service

Stanford, California, United States

Stanford Health Care

Stanford, California, United States

Bayview Research Group, LLC

Valley Village, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Emerson Clinical Research Institute

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

Children's National Medical Center

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

Velocity Clinical Research, Washington DC

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

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Acevedo Clinical Research Associates

Miami, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

Emory Children's Center Illness POD

Atlanta, Georgia, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Meridian Clinical Research, LLC

Macon, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Solaris Clinical Research

Meridian, Idaho, United States

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, United States

Novak Center for Children's Health

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Michigan Center of Medical Research

Bingham Farms, Michigan, United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Meridian Clinical Research, LLC

Hastings, Nebraska, United States

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, United States

Children's Hospital & Medical Center

Omaha, Nebraska, United States

Children's Physician's Clinic, Spring Valley

Omaha, Nebraska, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Rutgers University

New Brunswick, New Jersey, United States

Meridian Clinical Research LLC

Binghamton, New York, United States

Advanced Specialty Care

Commack, New York, United States

Rochester Clinical Research, Inc.

Rochester, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University

Stony Brook, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Atrium Health-STRIVE Vaccine Research Clinic

Charlotte, North Carolina, United States

Teen Health Connection (study visits)

Charlotte, North Carolina, United States

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States

Atrium Health-STRIVE Vaccine Research Clinic (study visits)

Matthews, North Carolina, United States

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, United States

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

PriMed Clinical Research

Dayton, Ohio, United States

Senders Pediatrics

South Euclid, Ohio, United States

Cyn3rgy Research

Gresham, Oregon, United States

AHN Erie Health + Wellness Pavillion: West

Erie, Pennsylvania, United States

Velocity Clinical Research-Providence

East Greenwich, Rhode Island, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Coastal Pediatric Research

Summerville, South Carolina, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Clinical Research Associates Inc

Nashville, Tennessee, United States

Innovo Research - Austin Regional Clinic

Austin, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Cedar Health Research

Dallas, Texas, United States

Bay Colony Pediatrics

Dickinson, Texas, United States

Proactive Clinical Research, LLC

Edinburg, Texas, United States

Village Health Partners (Patient Seen Address)

Frisco, Texas, United States

Helios Clinical Research - HOU

Houston, Texas, United States

Helios Clinical Research

Houston, Texas, United States

HG Pediatrics

Houston, Texas, United States

Van Tran Family Practice

Houston, Texas, United States

Texas Children's Hospital - Clinical Research Center

Houston, Texas, United States

West Houston Clinical Research Services

Houston, Texas, United States

DM Clinical Research - MDC

Houston, Texas, United States

Pediatric Associates

Houston, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Charlottesville, Virginia, United States

Virginia Research Center

Midlothian, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC

Salvador, Estado de Bahia, Brazil

Santa Casa De Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco

Curitiba, Paraná, Brazil

CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Natal, Rio Grande do Norte, Brazil

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.

São Paulo, Brazil

FVR, Oulu Clinic

Oulu, North Ostrobothnia, Finland

FVR, Järvenpää Clinic

Jarvenpaa, Uusimaa, Finland

FVR, Espoo Clinic

Espoo, Finland

FVR, Helsinki South Clinic

Helsinki, Finland

MeVac - Meilahti Vaccine Research Center

Helsinki, Finland

FVR, Helsinki East Clinic

Helsinki, Finland

FVR, Kokkola Clinic

Kokkola, Finland

FVR, Pori Clinic

Pori, Finland

FVR, Seinäjoki Clinic

Seinäjoki, Finland

FVR, Tampere Clinic

Tampere, Finland

FVR, Turku Clinic

Turku, Finland

CHRISTUS - LATAM HUB Center of excellence and innovation S.C.

Monterrey, Nuevo León, Mexico

Kohler & Milstein Research S.A. de C.V.

Mérida, Yucatán, Mexico

Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion

Mérida, Yucatán, Mexico

Sociedad de Metabolismo y Corazón S.C.

Veracruz, Mexico

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, Poland

IN-VIVO Bydgoszcz

Bydgoszcz, Poland

Centrum Badan Klinicznych JCI

Krakow, Poland

Osrodek Badan Klinicznych Appletreeclinics

Lodz, Poland

GRAVITA Diagnostyka i Leczenie nieplodnosci

Lodz, Poland

Rodzinne Centrum Medyczne LUBMED

Luboń, Poland

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, Poland

Provita 001

Warsaw, Poland

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

EBA Centelles

Centelles, Barcelona, Spain

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain

Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad de, Spain

Hospital de Antequera

Antequera, Málaga, Spain

Grupo Pediatrico Uncibay

Málaga, Málaga, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Instituto Hispalense de Pediatria

Seville, Spain

Clinical Research Directory

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (128)