Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00595309
First received: January 4, 2008
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.


Condition Intervention Phase
Japanese Encephalitis
Biological: IC51
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Seroconversion Rate [ Time Frame: at Month 12 after booster ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Adverse Events [ Time Frame: up to Month 12 after booster ] [ Designated as safety issue: Yes ]
  • Seroconversion [ Time Frame: at D28 and Month 6 after booster ] [ Designated as safety issue: No ]
  • Geometric Mean Titer [ Time Frame: D28, Month 6 and Month 12 after booster ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: December 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Biological: IC51
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided by Valneva Austria GmbH

Additional 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
Study First Received: January 4, 2008
Results First Received: May 24, 2012
Last Updated: May 5, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on October 23, 2014