IMMUNOGENICITY AND SAFETY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®, JESPECT®) IN A PEDIATRIC POPULATION IN NON-ENDEMIC COUNTRIES. UNCONTROLLED, OPEN-LABEL PHASE 3 STUDY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1- Male or female healthy children and adolescents aged = 2 months to < 18 years at the time of first vaccination
2- Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
3- Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche). For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4. is required
4- 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 Day 35 to 56 or between Day 56 to Month 7
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1- Clinical manifestation or history of any Flavivirus disease
2- Vaccination against JE (except within this protocol), Yellow fever, West e virus and Dengue at any time prior or during the study
3- Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
4- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days prior to the first vaccination at Visit 1
5- Immunodeficiency including post-organ-translpantation or a family history of congenital or hereditary immunodeficiency.
6- History of autoimmune disease.
7- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 4 weeks prior to vaccination at Visit 1 and during the study (For corticosteroids, this will mean prednisone, or equivalent, = 0.05 mg/kg/day. Topical and inhaled steroids are allowed.).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1- To assess immunogenicity of the purified inactivated Japanese Encephalitis (JE) vaccine IC51 using the Seroconversion rates (SCRs) and Geometric Mean Titers (GMTs) at Day 56 in a pediatric population from regions where JE is not endemic;Secondary Objective: 1- To assess the safety profile of IC51 in a pediatric population from regions where JE is not endemic<br>2- To assess differences in the immunogenicity and safety profile of IC51 in subjects depending on age groups, dose groups, TBE vaccination history and travel to JE endemic areas;Primary end point(s): 1- Co-primary endpoints: SCRs as defined by percentage of subjects with PRNT50 titers of = 1:10 at Day 56 and GMTs for JEV neutralizing antibodies measured using a validated Plaque Reduction Neutralization Test (PRNT) at Day 56

Secondary Outcome Measures

Name	Time	Method

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