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

Launched by SANOFI · Apr 28, 2006

Keywords

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Gender

ALL

Eligibility criteria

• 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.