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A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults

NCT00981175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2012-07-16

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Live attenuated Japanese encephalitis virus, then ChimeriVax diluent

ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28

BIOLOGICAL

ChimeriVax diluent, then Live attenuated Japanese encephalitis virus

ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-06-30
Completion
2008-02-29

Countries

  • Australia

Study Locations

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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 NCT00981175 on ClinicalTrials.gov