Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-09-30

Brief Summary

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The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.

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Detailed Description

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Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No treatment

subjects will be followed up on immunity (analysis of blood samples) and safety

Group Type OTHER

Blood draw

Intervention Type PROCEDURE

blood draw at Month 12, Month 24 and Month 36.

IC51 has given in the parent study IC51-322

Intervention Type BIOLOGICAL

No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

Interventions

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Blood draw

blood draw at Month 12, Month 24 and Month 36.

Intervention Type PROCEDURE

IC51 has given in the parent study IC51-322

No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322.
* Male or female healthy subjects aged ≥ 9 months to \< 21 years at the time of enrolment into this study.
* Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.

Exclusion Criteria

* History of or clinical manifestation of any Flavivirus disease during study IC51-322.
* Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study.
* Participation in another study with an investigational product during study IC51-322 or IC51-324.
* History of or development of any immunodeficiency including post-organtransplantation after inclusion into study IC51-322.
* History of or development of an autoimmune disease during study IC51-322.
* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-324. (For corticosteroids this means prednisone or equivalent at \>= 0.05 mg/kg/day. Topical or inhaled steroids are allowed).
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
* Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
* Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

Minimum Eligible Age

9 Months

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes