Status:
COMPLETED
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Lead Sponsor:
Sanofi
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
18-48 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and ...
Eligibility Criteria
Inclusion
- Written informed consent obtained.
- Aged ≥18 to \<49 years.
- In good general health.
- Available for the study duration, including all planned follow-up visits.
- Females must have negative pregnancy test and be using adequate form of contraception
Exclusion
- Clinically significant abnormalities on laboratory and vital sign assessments.
- Anaphylaxis or other serious adverse reactions
- Administration of another vaccine within 30 days of study treatment period.
- Physical examination indicating any significant medical condition.
- Intention to travel out of the area prior to the study visit on Day 56.
- Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
- Pregnancy.
- Excessive alcohol consumption, drug abuse.
- Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00319592
Start Date
May 1 2005
End Date
September 1 2006
Last Update
August 20 2012
Active Locations (1)
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1
Clinical Pharamacology Center
Lenexa, Kansas, United States, 66219