Japanese Encephalitis Clinical Trial
Official title:
Randomised, Double-blind, Placebo Controlled Phase II, Dose-ranging Study of the Safety, Tolerability and Immunogenicity of Live Attenuated ChimeriVax™-JE Vaccine (Lyophilised)
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new
formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with
placebo.
Primary Objectives:
Safety:
- To obtain safety and tolerability data for a single subcutaneous vaccination with
ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old).
Immunogenicity:
- To obtain data on the antibody response to a single subcutaneous vaccination with
ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior
Japanese encephalitis immunity.
- To assess the durability of immune response up to 12 months following a single
subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.
All participants will received a single dose of study vaccine, ChimeriVax™-JE or placebo on Day 0. The double-blind treatment phase will last 30 days, with follow-up visits at 6 and 12 months. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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