A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

Completed · Phase 2

Conditions studied: Japanese Encephalitis

In brief

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 several wild types strains after completion of vaccination course.

Key facts

Study ID

NCT00319592

Run by

Sanofi

People needed

60

Starts

2005-05-01

Expected to finish

2006-09-01

Last updated by the study team

2012-08-20

Who can join

Age: 18 and older, up to 48. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Pharamacology Center — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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