NCT02039440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

January 16, 2014

Last Update Submit

February 20, 2015

Conditions

Post Other Specified Vaccination Encephalitis

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT

    1.5 years

Secondary Outcomes (1)

  • Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT

    1.5 years

Other Outcomes (1)

  • Projected mean duration of protection after a booster dose of JE-VC

    1.5 years

Study Arms (1)

Single arm

OTHER

1 blood draw

Other: Blood draw

Interventions

Blood drawOTHER

One-time blood draw

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Specific Prophylaxis and Tropical Medicine

Vienna, Kinderspitalgasse 15, 1090, Austria

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Herwig Kollaritsch, Prof. Dr.

    Medizinische Universität Wien, Institut für Spezifische Prophylaxe und Tropenmedizin 1090 Wien, Kinderspitalgasse 15

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr.med.univ.

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations

AU(1)