This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

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

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

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


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

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 identifier: NCT00595309

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Valneva Austria GmbH 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

Additional relevant MeSH terms:
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 processed this record on July 26, 2017