Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
1 other identifier
interventional
198
2 countries
3
Brief Summary
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
June 27, 2012
CompletedMay 16, 2014
May 1, 2014
1.8 years
January 4, 2008
May 24, 2012
May 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Seroconversion Rate
at Month 12 after booster
Secondary Outcomes (3)
Safety and Adverse Events
up to Month 12 after booster
Seroconversion
at D28 and Month 6 after booster
Geometric Mean Titer
D28, Month 6 and Month 12 after booster
Study Arms (1)
A
ACTIVE COMPARATORInterventions
IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
Related Publications (1)
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.
PMID: 21288804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager Clinical Research
- Organization
- Intercell AG
Study Officials
- STUDY DIRECTOR
Susanne Eder
Valneva Austria GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
December 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
May 16, 2014
Results First Posted
June 27, 2012
Record last verified: 2014-05