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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: JE-VAX®; Biological: ChimeriVax™-JE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314145

H-040-009

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 ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Enrollment: 820 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects aged 18 or above
• Subjects in good general health.
• Females must have negative pregnancy test and be using adequate form of contraception

Exclusion criteria

• History of vaccination/infection with JE or Yellow fever or other flaviviruses
• History of residence/travel to flavivirus endemic regions
• History of anaphylaxis/serious adverse reactions
• Administration of vaccine within 30 days of study or during treatment period
• Clinically significant physical exam/medical history/lab abnormalities
• Pregnancy
• Excessive alcohol/drug abuse
• Hypersensitivity to constituents of JE-VAX®
• Blood transfusion/treatment with blood product within 6months of study and during study treatment period
• Known/suspected immunodeficiency
• Compromised blood brain barrier
• Employees of Clinical Research Organization (CRO)/study site staff
• Any other condition which would exclude subject.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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820 participants in 2 patient groups

ChimeriVax™-JE

Experimental group

Description:

Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.

Treatment:

Biological: ChimeriVax™-JE

JE-VAX®

Active Comparator group

Description:

Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.

Treatment:

Biological: JE-VAX®