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Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults

NCT00746798 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2015-04-03

Study results available
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Summary

The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.

Conditions

  • West Nile Fever

Interventions

BIOLOGICAL

ChimeriVax-WN02 vaccine

low dose, approximately 4 x 3log10, given one time subcutaneously

BIOLOGICAL

ChimeriVax-WN02 vaccine

medium dose, approximately 4 x 4log10, given one time

BIOLOGICAL

ChimeriVax-WN02 vaccine

high dose, approximately 4 x 5log10, given one time subcutaneously

BIOLOGICAL

Placebo

0.9%Normal Saline for Injection, given one time subcutaneously

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00746798 on ClinicalTrials.gov