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

Valneva

Status and phase: Completed; Phase 3

Conditions: Encephalitis

Treatments: Biological: IC51

Study type: Interventional

Funder types: Industry

Identifiers

NCT01047839

IC51-322

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 2 months to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

>=2 months to <3 years

Experimental group

Description:

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

Treatment:

Biological: IC51

Biological: IC51

Biological: IC51

>=3 to <12 years

Experimental group

Description:

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

Treatment:

Biological: IC51

Biological: IC51

Biological: IC51

>=12 to <18 years

Experimental group

Description:

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

Treatment:

Biological: IC51

Biological: IC51

Biological: IC51