ONG TERM IMMUNITY AND SAFETY WITH OR WITHOUT A BOOSTER DOSE FOLLOWING PRIMARY VACCINATION WITH THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®) IN A PEDIATRIC POPULATION.

• Conditions: Japanese Encephalitis (JE); MedDRA version: 14.1Level: PTClassification code 10014596Term: Encephalitis Japanese BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10023120Term: Japanese B viral encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10023122Term: Japanese B virus encephalitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10023119Term: Japanese B encephalitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-022265-10-Outside-EU/EEA
• Lead Sponsor: Intercell AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol.
2.Children who have received the dose confirmed for their age group.
3.Male or female healthy children and adolescents aged =9 months to <17 years and 7 months at the time of enrolment into this study.
4.Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
5.Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche) at Visits 1, 2 and 2a as stipulated by the protocol. For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4.

Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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.Vaccination against JE virus (JEV) (except within study IC51-323 and IC51 325), Yellow fever, West e virus and Dengue fever at any time prior to or planned during the study.
2.History of or clinical manifestation of any Flavivirus disease during IC51-323 or IC51 325.
3.Participation in another study with an investigational drug during IC51 323 or IC51 325.
4.Planned active or passive immunization within 2 weeks before and 1 week after the IXIARO booster.
5.History of or development of any immunodeficiency including post-organ-transplantation after inclusion into IC51-323 or IC51 325.
6.History of or development of an autoimmune disease during study IC51-323 or IC51 325.
7.Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during IC51-323 or IC51 325. (For corticosteroids, this would mean prednisone or equivalent at >=0.05 mg/kg/day; topical and inhaled steroids are allowed).
8.Acute febrile infection at Visit 2 (only for the Booster Group).
9.Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable contraception in female subjects after onset of menarche.
10.Hypersensitivity reactions to IXIARO or adverse events in study IC51-323 requiring withdrawal from further vaccination or anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission during IC51-323 or IC51 325.
11.History of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic cause during IC51-323 or IC51 325.
12.Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) (measurement of Hepatitis B surface antigen [HBsAg] titers) or hepatitis C virus (HCV).
13.Illicit drug use and/or current drug or alcohol addiction.
14.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.
15.Persons who have been committed to an institution (by a court or by an authority).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified