Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 - Full Text View

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00595309

Purpose

The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

Condition	Intervention	Phase
Japanese Encephalitis	Biological: IC51	Phase III

MedlinePlus related topics: Encephalitis

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-Label Phase 3 Study.

Further study details as provided by Intercell AG:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	200
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Biological: IC51 IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

Eligibility

Criteria

Main Inclusion Criteria:

Healthy adults who completed the primary immunization in study IC51 309
Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595309

Locations

Austria
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Vienna, Austria
Zentrum für Reisemedizin, Dependance für klinische Studien
Vienna, Austria
Germany
Berliner Zentrum Reise- und Tropenmedizin
Berlin, Germany

Sponsors and Collaborators

Intercell AG

Investigators

Study Director:

Susanne Eder

Intercell AG

More Information

Responsible Party:	Intercell AG
Study ID Numbers:	IC51-311
Study First Received:	January 4, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00595309
Health Authority:	Germany: Paul-Ehrlich-Institut; Austria: Agency for Health and Food Safety

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