Status:
COMPLETED
Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
West Nile Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 st...
Detailed Description
West Nile Disease has been carried across the United States by migrating birds since it was first identified in New York city in 1999. It is transmitted by mosquitoes from birds to humans and can caus...
Eligibility Criteria
Inclusion
- Part 1
- Healthy adult aged 18 to 40 years.
- Women of child-bearing potential should be using hormonal contraception.
- Subject had to be available for the study duration, including all planned follow-up visits.
Exclusion
- Part 1
- Previous vaccination against yellow fever or Japanese encephalitis
- History of flavivirus infection
- Any abnormalities of immune system, or using drugs that affect the immune system.
- History of anaphylaxis to foods, bee stings, vaccines or drugs.
- Receipt of blood or blood products within the preceding 6 months.
- Receipt of any vaccine in the preceding 30 days
- Seropositive to hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)
- Lactation or intended pregnancy in female subjects
- Previous or current military service with overseas deployment
- Travel to Mexico or other flavivirus endemic areas in the tropics for periods of four weeks or more in the previous ten years.
- Inclusion Criteria: Part 2
- Aged ≥ 41 years.
- Subjects had to be in general good health.
- Unimpaired cognitive performance as assessed by clock drawing test score
- Subject had to be available for all required study visits, including all planned follow-up visits.
- Women of child-bearing potential should be using hormonal contraception.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00442169
Start Date
December 1 2005
End Date
April 1 2009
Last Update
April 14 2016
Active Locations (5)
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1
HOPE Research Institute
Phoenix, Arizona, United States, 85050
2
Idaho Infectious Diseases, PLLC
Idaho Falls, Idaho, United States, 83404
3
PRA International Clinical Pharmacology Center
Lenexa, Kansas, United States, 66219
4
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802