6-year Antibody Check After Third Vaccination Against Jap... | NCT02039440

Studies
6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

NCT02039440

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Feb 23, 2015Estimated

Enrollment

67Actual

Phase

Phase 4

Conditions

Post Other Specified Vaccination Encephalitis

Interventions

Blood draw

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-004366-34	EudraCT Number

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Jan 16, 2014

First Posted Date

Jan 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2015

Last Update Posted Date

Feb 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Herwig Kollaritsch, Ao.Univ.-Prof. Dr.med.univ., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.

Detailed Description

Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age.

The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Other	1 blood draw	Other: Blood draw

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Other	One-time blood draw	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT		1.5 years

Secondary Outcomes

Measure	Description	Time Frame
Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT		1.5 years

Other Outcomes

Measure	Description	Time Frame
Projected mean duration of protection after a booster dose of JE-VC		1.5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who received a booster dose of JE-VC in study IC51-311
Subjects who are willing to give written informed consent to participate in the trial

Exclusion Criteria:

Subjects who received a further dose of any Japanese Encephalitis Vaccine since study IC51-311
Severe immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy
simultaneous participation in another clinical study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Herwig Kollaritsch, Prof. Dr.	Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Specific Prophylaxis and Tropical Medicine		Vienna	Kinderspitalgasse 15	1090	Austria

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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