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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 ≥5 TO <12 YEARS OF AGE

Study category: Infectious Diseases

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Description

In this new study, we will learn if the vaccine can produce an immune response against COVID-19, and if it is safe, in children 5-11 years old. All participants will have the opportunity to receive the COVID-19 study vaccine during their time in the trial.

Details
Age

Child

Eligibility

Healthy Children Ages 5-11 Years Old

Phase

II/III - A combination of phases: (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. and (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

Childrens Hospital Colorado

Principal Investigator
Eric Simoes,  MD

Eric Simoes, MD

Study ID

Protocol Number: 21-2841

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