Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-08-31

Brief Summary

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The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

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Detailed Description

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Conditions

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Encephalitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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>=2 months to <3 years

IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28

Group Type EXPERIMENTAL

IC51

Intervention Type BIOLOGICAL

0.25 ml, 2 i.m. vaccinations at Day 0 and 28

>=3 to <12 years

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Group Type EXPERIMENTAL

IC51

Intervention Type BIOLOGICAL

0.5 ml, 2 i.m. vaccinations at Day 0 and 28

>=12 to <18 years

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Group Type EXPERIMENTAL

IC51

Intervention Type BIOLOGICAL

0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Interventions

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IC51

0.25 ml, 2 i.m. vaccinations at Day 0 and 28

Intervention Type BIOLOGICAL

IC51

0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Intervention Type BIOLOGICAL

IC51

0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female healthy children and adolescents aged \>=2 months to \<18 years at the time of first vaccination
* Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
* Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception.
* The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion Criteria

* Clinical manifestation or history of any Flavivirus disease
* Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
* History of immunodeficiency or immunosuppressive therapy
* Known HIV, HBV or HCV infection
* History of hypersensitivity reactions to other vaccines
* Acute febrile infection at each visit during which the subject receives a vaccination
* Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.

Minimum Eligible Age

2 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes