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

Conditions: Japanese Encephalitis (JE)
MedDRA version: 13.1Level: PTClassification code 10014596Term: Encephalitis Japanese BSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 13.1Level: LLTClassification code 10023120Term: Japanese B viral encephalitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 13.1Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 13.1Level: LLTClassification code 10023122Term: Japanese B virus encephalitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 13.1Level: LLTClassification code 10023119Term: Japanese B encephalitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2009-015595-10-SE

Lead Sponsor: Intercell AG

Brief Summary: Not available

Detailed Description: Not available

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: 100
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).
8- Acute febrile infection at each visit during which the subject receives a vaccination
9- History of hypersensitivity reactions to vaccines
10- Known HIV, HBV or HCV infection

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;Timepoint(s) of evaluation of this end point: after the end of the study<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): SCRs and GMTs at Day 56 and Month 7 stratified according to dose groups, age groups, Tick-borne Encephalitis (TBE) vaccination history, travel to JE endemic areas, travel to JE endemic areas before Day 56, as well as travel to JE endemic areas after Day 56. <br>;Timepoint(s) of evaluation of this end point: after the end of the study<br>

Related Trials