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

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00594958

Purpose

The objective is to demonstrate equivalence of three 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), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Three 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:

Arms	Assigned Interventions
Group A: Active Comparator	Biological: Japanese Encephalitis purified inactivated vaccine 6 mcg, intramuscularly [i.m.], 0.5 mL
Group B: Active Comparator	Biological: Japanese Encephalitis purified inactivated vaccine 6 mcg, intramuscularly [i.m.], 0.5 mL
Group C: Active Comparator	Biological: Japanese Encephalitis purified inactivated vaccine 6 mcg, intramuscularly [i.m.], 0.5 mL

Eligibility

Criteria

Main Inclusion Criteria:

Male and female 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 HIV, drug addiction including alcohol dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594958

Sponsors and Collaborators

Intercell AG

Investigators

Study Director:

Astrid Kaltenboeck, Ph.D.

Intercell AG

More Information

Responsible Party:	Intercell AG
Study ID Numbers:	IC51-309
Study First Received:	January 4, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00594958
Health Authority:	Germany: Paul-Ehrlich-Institut; Austria: Agency for Health and Food Safety; United States: Food and Drug 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