Clinical trial NCT00314145: A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Official title: A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
timeFrame: Up to Day 60 post-first vaccination
measure: Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
timeFrame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Secondary outcomes:
measure: Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
timeFrame: Up to Day 60 post-first vaccination
measure: Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
timeFrame: Day 60 post-first vaccination
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Shawnee Mission
country: United States
state: Kansas
city: Missoula
country: United States
state: Montana
city: Dallas
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Adelaide
country: Australia
city: Melbourne
country: Australia
city: New South Wales
country: Australia
city: Queensland
country: Australia
city: Victoria
country: Australia
Study officials:
affiliation: Heart of America Research Institute
name: Luis Angles, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.