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

NCT ID: NCT01296360

Last Updated: 2014-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-10-31

Brief Summary

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.

Detailed 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.

Conditions

Japanese Encephalitis

Keywords

immune response; IC51-325; Japanese Encephalitis; Intercell AG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

>14 months to <2 years

IXIARO 0.25 ml i.m. (milliliter, intramuscular)

Group Type: ACTIVE_COMPARATOR

IXIARO

Intervention Type: BIOLOGICAL

0.25 ml i.m. (milliliter, intramuscular)

>3 years - <18 years

IXIARO 0.5 ml i.m (milliliter, intramuscular)

Group Type: ACTIVE_COMPARATOR

IXIARO

Intervention Type: BIOLOGICAL

0.5 ml i.m. (milliliter, intramuscular)

Interventions

IXIARO

0.25 ml i.m. (milliliter, intramuscular)

Intervention Type: BIOLOGICAL

IXIARO

0.5 ml i.m. (milliliter, intramuscular)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Valneva Austria GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Kadlecek, Mag.

Role: STUDY_CHAIR

Valneva Austria GmbH

Locations

Research Institute for Tropical Medicine - Clinical Research Division

City of Muntinlupa, Alabang, Philippines

Research Institute for Tropical Medicine

City of Muntinlupa, Alabang, Philippines

UP-Philippine General Hospital

Manila, Manila, Philippines

Countries

Philippines

Other Identifiers

IC51-325

Identifier Type: -

Identifier Source: org_study_id