6-year antibody check after third vaccination against Japanese Encephalitis

Neutralizing Antibody Titers 6 Years after the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection - JE-VC Serology Post Booster

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004366-34-AT

Enrollment

100

Registered

2013-11-13

Start date

2013-12-13

Completion date

Unknown

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Study population: adult volunteers who received a booster dose of JE-VC in prestudy IC51-311, no specific medical condition is investigated, only antibody check.

Interventions

Trade Name: IXIARO® suspension for injection Product Name: Ixiaro Pharmaceutical Form: Suspension for injection INN or Proposed INN: Japanese Encephalitis Vaccine (inactivated) CAS Number: NA Current

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Subjects who received a further dose of any Japanese Encephalitis since study IC51-311 Subjects immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy. Current participation in another trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective is to refine the mathematical modeling of antibody decline and the duration of protection following a booster of JE-VC.;Secondary Objective: Secondary objective is to determine the persistence of JEV neutralizing antibodies approximately 6 years after a booster dose of JE-VC.;Primary end point(s): Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT.;Timepoint(s) of evaluation of this end point: 2014	—

Measure

Time frame

Main Objective: Primary objective is to refine the mathematical modeling of antibody decline and the duration of protection following a booster of JE-VC.;Secondary Objective: Secondary objective is to determine the persistence of JEV neutralizing antibodies approximately 6 years after a booster dose of JE-VC.;Primary end point(s): Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT.;Timepoint(s) of evaluation of this end point: 2014

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 2014;Secondary end point(s): Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers = 1:10 in a PRNT50 SPR stratified by Tick-borne encephalitis vaccination history. GMT stratified by Tick-borne encephalitis vaccination history. Projected mean duration of protection after a booster dose of JE-VC.	—

Countries

Austria, Germany

Contacts

Public ContactStudienpersonal

Medizinische Universität Wien - Institut für Spezifische Prophylaxe und Tropenmedizin

tropenmedizin@gmail.com004314016038276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026