Safety and Immunogenicity of 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: EUCTR2009-015588-15-Outside-EU/EEA

Lead Sponsor: Intercell AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 1867

Inclusion Criteria

1Male or female healthy children and adolescents aged = 2 months to < 18 years at the time of first vaccination.
2Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
3Female 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1867
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 of Japanese Encephalitis
2- History of Flavivirus vaccination (including any investigational vaccines)
3- History of vaccination with Prevnar® (only for children aged < 1 year) and HAVRIX®720
4- History of immunodeficiency or immunosuppressive therapy
5- Known HIV, HBV or HCV infection
6- History of hypersensitivity reactions to other vaccines
7- Acute febrile infection at each visit during which the subject receives a vaccination
8- For children aged = 6 months at first vaccination, active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to one week after the second IC51 vaccination. For children aged < 6 months, active or passive immunization within 1 week before and 1 week after each IC51 vaccination.