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First received: June 02, 2023

Clinical Trial: A Study to Learn About the Safety and Immune Activity of RSVpreF in Children Who Are at High Risk of Getting RSV Disease

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: RESPIRATORY SYNCYTIAL VIRUS (RSV)

Study Type: INTERVENTIONAL


Official Title: A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY AND A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATO

Brief Summary: The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age who are at high risk of RSV disease.Phase 1 will identify the dose level to be used in Phase 2/3.In this phase, all participants will receive one injection of RSVpreF.Phase 1 has four study visits, two in-clinic and two telehealth visits.Blood samples will be collected for testing.This phase is about 6 months long for each participant and will be conducted in the…

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