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Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

2014-08-27 03:19:11 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Japanese Encephalitis

Intervention

Live attenuated Japanese encephalitis virus, Live attenuated Japanese encephalitis virus, Live attenuated Japanese encephalitis virus, ChimeriVax™ diluent

Location

Herston
Queensland
Australia
QLD 4006

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:11-0400

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PubMed Articles [7626 Associated PubMed Articles listed on BioPortfolio]

The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: results of two phase 3 studies.

Quadrivalent live attenuated influenza vaccine (Q/LAIV) has not been assessed in Japanese children.

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Medical and Biotech [MESH] Definitions

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), found in Australia and New Guinea. It causes a fulminating viremia resembling Japanese encephalitis (ENCEPHALITIS, JAPANESE).

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), which is the etiological agent of Japanese encephalitis found in Asia, southeast Asia, and the Indian subcontinent.

A subgroup of the genus FLAVIVIRUS which comprises a number of viral species that are the etiologic agents of human encephalitis in many different geographical regions. These include Japanese encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE), St. Louis encephalitis virus (ENCEPHALITIS VIRUS, ST. LOUIS), Murray Valley encephalitis virus (ENCEPHALITIS VIRUS, MURRAY VALLEY), and WEST NILE VIRUS.

A species of FLAVIVIRUS, one of the Japanese encephalitis virus group (ENCEPHALITIS VIRUSES, JAPANESE), which is the etiologic agent of ST. LOUIS ENCEPHALITIS in the United States, the Caribbean, and Central and South America.

Vaccines or candidate vaccines used to prevent infection with Japanese B encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE).

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