CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 208 enrolled
Drug / intervention
ChimeriVax-WN02 Low Dose +5 morebiological
Likely dose
ChimeriVax-WN02 Low Dose 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00442169
NCT00442169Phase 2Completed

Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

Sanofi Pasteur, a Sanofi Company·interventional·Posted Mar 1, 2007·Updated Apr 14, 2016

In Brief

A Phase 2 clinical trial evaluating ChimeriVax-WN02 Low Dose, ChimeriVax-WN02 Medium Dose, and 3 other interventions for West Nile Fever. Completed, enrolled 208 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWest Nile Fever
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartDec 1, 2005
Primary CompletionJun 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.3 years ago

Interventions

ChimeriVax-WN02 Low Dosebiological

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

ChimeriVax-WN02 Medium Dosebiological

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

ChimeriVax-WN02 High Dosebiological

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

0.9% Saline solutionbiological

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

ChimeriVax-WN02 High Dosebiological

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

0.9 % NaCl solutionbiological

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