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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Japanese Encephalitis

Treatments

Biological: JE-VAX® vaccine

Biological: ChimeriVax™-JE vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00319592

H-040-008

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 48 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.