Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51 - Full Text View

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00595465

Purpose

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Condition	Intervention	Phase
Japanese Encephalitis	Biological: Japanese Encephalitis purified inactivated vaccine	Phase III

MedlinePlus related topics: Encephalitis

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.

Further study details as provided by Intercell AG:

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment:	389
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Active Comparator	Biological: Japanese Encephalitis purified inactivated vaccine IC51 6 mcg i.m. injection on Day 0 and Day 28
Group B: Active Comparator	Biological: Japanese Encephalitis purified inactivated vaccine IC51 6 mcg i.m. injection on Day 0 and Day 28
Group C: Active Comparator	Biological: Japanese Encephalitis purified inactivated vaccine IC51 6 mcg i.m. injection on Day 0 and Day 28

Eligibility

Criteria

Main Inclusion Criteria:

Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595465

Locations

Austria
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Vienna, Austria, 1090
Germany
Klinik und Poliklinik für Innere Medizin der Universität Rostock
Rostock, Germany, 18057
Berliner Zentrum Reise- und Tropenmedizin
Berlin, Germany, 10117
Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
Munich, Germany, 80802

Sponsors and Collaborators

Intercell AG

Investigators

Study Director:

Nicole Haas

Intercell AG

More Information

Responsible Party:	Intercell AG
Study ID Numbers:	IC51-310
Study First Received:	January 4, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00595465
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