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Effect of a Booster Dose 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: NCT00595309
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : June 27, 2012
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: IC51 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.
Study Start Date : December 2007
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A Biological: IC51
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization


Outcome Measures

Primary Outcome Measures :
  1. Seroconversion Rate [ Time Frame: at Month 12 after booster ]

Secondary Outcome Measures :
  1. Safety and Adverse Events [ Time Frame: up to Month 12 after booster ]
  2. Seroconversion [ Time Frame: at D28 and Month 6 after booster ]
  3. Geometric Mean Titer [ Time Frame: D28, Month 6 and Month 12 after booster ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • Healthy adults who completed the primary immunization in study IC51 309
  • Male and female healthy 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 Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence

Contacts and Locations

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): NCT00595309


Locations
Austria
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Vienna, Austria
Zentrum für Reisemedizin, Dependance für klinische Studien
Vienna, Austria
Germany
Berliner Zentrum Reise- und Tropenmedizin
Berlin, Germany
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Susanne Eder Valneva Austria GmbH
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595309     History of Changes
Other Study ID Numbers: IC51-311
First Posted: January 16, 2008    Key Record Dates
Results First Posted: June 27, 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