Trial Profile

A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 13 Mar 2025

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At a glance

18 Mar 2024 Phase of the study is changed from phase 1/2/3 to phase 1 only. Thus all primary end-points pertaining to phase 2/3 are removed and treatment arms also reduced from 9 to 6 by he removal of 2 experimental arms and 1 placebo arm. Study design is changed from double-blind, parallel to open, sequential. PD is removed from trial focus.
18 Mar 2024 Status changed from active, no longer recruiting to completed.
04 Mar 2024 Planned End Date changed from 4 Mar 2024 to 29 Feb 2024.

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