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Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

NCT00442169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2016-04-14

Study results available
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Summary

The purpose of this study is to determine whether a single subcutaneous injection of ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against West Nile Disease. The study is divided into two parts; in the first part, a comparison of 3 dose levels of the vaccine will be made, with an inactive control. In the second part, the optimum dose level chosen after the first part will be given to older volunteers.

Conditions

  • West Nile Fever

Interventions

BIOLOGICAL

ChimeriVax-WN02 Low Dose

Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region.

BIOLOGICAL

ChimeriVax-WN02 Medium Dose

Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region

BIOLOGICAL

ChimeriVax-WN02 High Dose

Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region

BIOLOGICAL

0.9% Saline solution

Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region

BIOLOGICAL

ChimeriVax-WN02 High Dose

Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region

BIOLOGICAL

0.9 % NaCl solution

Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region

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
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-06-30
Completion
2009-04-30

Countries

  • United States

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 NCT00442169 on ClinicalTrials.gov