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

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: ChimeriVax™-JE; Biological: JE-VAX®

• Registration Number: NCT00314145
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-13
• Primary Completion: 2006-06
• Study Completion: 2006-11
• Results First Submitted: 2012-11-06
• Results First Submitted QC: 2012-11-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Results First Posted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChimeriVax™-JE	ChimeriVax™-JE	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.
JE-VAX®	JE-VAX®	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination	Up to Day 60 post-first vaccination	Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®	Day 0 (Pre-vaccination) up to 60 days post-first vaccination	Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.; Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.

Secondary Outcome Measures

Name	Time	Method
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination	Up to Day 60 post-first vaccination	Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination	Day 60 post-first vaccination	Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).