Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Study Director: Nicole Haas Valneva Austria GmbH
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595465    
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:
Layout table for MeSH terms
Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections