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Phase 1-3 evaluation of SARS-COV-2 RNA Vaccine Candidates in Children 5-12

PRIMARY OBJECTIVE(s)

To describe the safety and tolerability profiles of prophylactic BNT162 vaccines at each dose level for each age group. 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. (Duke is a contributing site for this multi-center study.)

PRINCIPAL INVESTIGATOR(S)

Emmanuel Walter, MD

CONTACT
Emily Randolph
emily.randolph@duke.edu
TREATMENT/CLINICAL & LAB INVESTIGATION

Clinical and Laboratory Investigation

POPULATION
Male or female participants, ≥ 5 to <18 years of age
FULL NAME OF DIAGNOSTIC TEST
Lab Used for Diagnostic Test
Full Name of Serology/Antibody Test
Lab Used for Serology/Antibody Test
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