At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised, Double-blind, Phase 2 Study of the Safety, Immunogenicity and Duration of Immunity of ChimeriVax™-JE, Live Attenuated Vaccine in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating Live attenuated Japanese encephalitis virus, then ChimeriVax diluent and ChimeriVax diluent, then Live attenuated Japanese encephalitis virus for Encephalitis and Japanese Encephalitis. Completed, enrolled 202 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults. Objectives: Safety: * Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared with a placebo in adult volunteers (≥ 18 to \<55 years) without prior Japanese encephalitis (JE) vaccination. Immunogenicity: * Obtain data on the antibody response in adult volunteers following administration of ChimeriVax™-JE * Assess the durability of the immune response in adult volunteers over 60 months following one or two doses of ChimeriVax™-JE.
Study Details
Timeline
Interventions
ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.