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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: May 5, 2014
Last verified: May 2014
  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 (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.

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 ]

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

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: May 5, 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

ClinicalTrials.gov processed this record on May 22, 2017