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Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine

NCT00981630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2012-12-05

Study results available
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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.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Live attenuated Japanese encephalitis virus

0.5 mL,Subcutaneous

BIOLOGICAL

Live attenuated Japanese encephalitis virus

0.5 mL, Subcutaneous

BIOLOGICAL

Live attenuated Japanese encephalitis virus

0.5 mL, Subcutaneous

BIOLOGICAL

ChimeriVax™ diluent (Placebo)

0.5 mL, Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2006-02-28
Completion
2007-11-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00981630 on ClinicalTrials.gov