Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

Valneva

Status and phase

Completed

Phase 3

Conditions

Japanese Encephalitis

Treatments

Biological: IXIARO

Study type

Interventional

Funder types

Industry

Identifiers

NCT01296360

IC51-325

Details and patient eligibility

About

This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.

Full description

This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in the previous study IC51-323.

Enrollment

300 patients

Sex

All

Ages

9 months to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol.
Children who have received the dose confirmed for their age group.
Male or female healthy children and adolescents aged ≥9 months to <17 years and 7 months at the time of enrolment into this study.
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 (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

Exclusion criteria

Vaccination against JE virus (JEV) (except within study IC51-323 and IC51 325), Yellow fever, West Nile virus and Dengue fever at any time prior to or planned during the study.
History of or clinical manifestation of any Flavivirus disease during IC51-323 or IC51 325.
Participation in another study with an investigational drug during IC51 323 or IC51 325.
Planned active or passive immunization within 2 weeks before and 1 week after the IXIARO booster.
History of or development of any immunodeficiency including post-organ-transplantation after inclusion into IC51-323 or IC51 325.
History of or development of an autoimmune disease during study IC51-323 or IC51 325.
- 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).
Acute febrile infection at Visit 2 (only for the Booster Group).
Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable contraception in female subjects after onset of menarche.
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.
History of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic cause during IC51-323 or IC51 325.
Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) (measurement of Hepatitis B surface antigen [HBsAg] titers) or hepatitis C virus (HCV).
Illicit drug use and/or current drug or alcohol addiction.
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.
Persons who have been committed to an institution (by a court or by an authority).