Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00595465
First received: January 4, 2008
Last updated: October 19, 2012
Last verified: October 2012
  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 3

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

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion Rate [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Safety and Adverse Events [ Time Frame: Day 56 ] [ Designated as safety issue: Yes ]

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

  Eligibility

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

  • 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: NCT00595465

Locations
Austria
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Vienna, Austria, 1090
Germany
Berliner Zentrum Reise- und Tropenmedizin
Berlin, Germany, 10117
Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
Munich, Germany, 80802
Klinik und Poliklinik für Innere Medizin der Universität Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Nicole Haas Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595465     History of Changes
Other Study ID Numbers: IC51-310
Study First Received: January 4, 2008
Results First Received: June 1, 2012
Last Updated: October 19, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 23, 2014