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Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

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ClinicalTrials.gov Identifier: NCT00595465
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : November 20, 2012
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

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

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: Japanese Encephalitis purified inactivated vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Study Start Date : December 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody [ Time Frame: Day 56 ]

Secondary Outcome Measures :
  1. Seroconversion Rate [ Time Frame: Day 56 ]
  2. Safety and Adverse Events [ Time Frame: Day 56 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595465     History of Changes
Other Study ID Numbers: IC51-310
First Posted: January 16, 2008    Key Record Dates
Results First Posted: November 20, 2012
Last Update Posted: May 16, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs