Back to resultsEffect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IC51
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
Eligibility 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
Sites / Locations
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Zentrum für Reisemedizin, Dependance für klinische Studien
- Berliner Zentrum Reise- und Tropenmedizin
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Seroconversion Rate
Secondary Outcome Measures
Safety and Adverse Events
Seroconversion
Geometric Mean Titer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00595309
Brief Title
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
IC51
Intervention Description
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization
Primary Outcome Measure Information:
Title
Seroconversion Rate
Time Frame
at Month 12 after booster
Secondary Outcome Measure Information:
Title
Safety and Adverse Events
Time Frame
up to Month 12 after booster
Title
Seroconversion
Time Frame
at D28 and Month 6 after booster
Title
Geometric Mean Titer
Time Frame
D28, Month 6 and Month 12 after booster
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Eder
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
City
Vienna
Country
Austria
Facility Name
Zentrum für Reisemedizin, Dependance für klinische Studien
City
Vienna
Country
Austria
Facility Name
Berliner Zentrum Reise- und Tropenmedizin
City
Berlin
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21288804
Citation
Eder S, Dubischar-Kastner K, Firbas C, Jelinek T, Jilma B, Kaltenboeck A, Knappik M, Kollaritsch H, Kundi M, Paulke-Korinek M, Schuller E, Klade CS. Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO(R), IC51. Vaccine. 2011 Mar 21;29(14):2607-12. doi: 10.1016/j.vaccine.2011.01.058. Epub 2011 Feb 1.
Results Reference
derived
Learn more about this trial
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
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