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

Completed · Phase 3 · Has a placebo group

Conditions studied: SARS-CoV-2 Infection, COVID-19

In brief

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.

Key facts

Study ID

NCT04816643

Run by

BioNTech SE

People needed

11837

Starts

2021-03-24

Expected to finish

2023-12-08

Last updated by the study team

2026-05-28

Who can join

Age: 1 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• 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.
• 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.
• Negative urine pregnancy test for female participants who are biologically capable of having children.
• 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.
• 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).

You may not qualify if…

• 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.
• Phase 1 only: Known infection with HIV, HCV, or HBV.
• Receipt of medications intended to prevent COVID-19.
• Previous or current diagnosis of MIS-C.
• 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
• 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.
• 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.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Female who is pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• 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.
• 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.
• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
• Previous participation in other studies involving study intervention containing LNPs.
• 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.

Where it is running

• 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
• University of Alabama at Birmingham - School of Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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