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

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00314145

Purpose

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.

Condition	Intervention	Phase
Japanese Encephalitis	Biological: ChimeriVaxTM-JE Biological: JE-VAX	Phase III

MedlinePlus related topics: Encephalitis

Drug Information available for: Japanese Encephalitis Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:

816

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 CRO/study site staff
Any other condition which would exclude subject

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314145

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Luis Angles, M.D.

Heart of America Research Institute

More Information

Study ID Numbers:	H-040-009
Study First Received:	April 11, 2006
Last Updated:	April 24, 2007
ClinicalTrials.gov Identifier:	NCT00314145
Health Authority:	United States: Food and Drug Administration; Australia: Therapeutic Goods Administration

Study placed in the following topic categories:

Virus Diseases
Japanese encephalitis
Central Nervous System Infections
Central Nervous System Diseases

Encephalitis, Japanese
Arbovirus Infections
Brain Diseases
Encephalitis

Additional relevant MeSH terms:

Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009