Clinical trial NCT01047839: Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Official title: Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis
Keywords: Pediatric
Japanese Encephalitis Vaccine
non-endemic countries
to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
timeFrame: until Day 56
Secondary outcomes:
measure: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
timeFrame: up to Month 7
measure: Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
timeFrame: 7 days
measure: Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
timeFrame: up to Day 56 and upt to Month 7
measure: Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
timeFrame: up to Month 7
measure: SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
timeFrame: at Day 56 and Month 7
measure: GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
timeFrame: at Day 56 and Month 7
measure: SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
timeFrame: at Day 56 and Month 7
measure: GMTs at Day 56 and Month 7 Stratified According to Age Groups
timeFrame: at Day 56 and Month 7
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa Clinical Research Inc.
state: Florida
city: Baltimore
country: United States
facility: Passport Health
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Brisbane
country: Australia
facility: Dr. Deb - The Travel Doctor
state: Queensland
city: Melbourne
country: Australia
facility: Travel Doctor - TMVC Australia
state: Victoria
city: Soborg
country: Denmark
facility: Danske Laegers Forsknings Center
city: Berlin
country: Germany
facility: Berliner Zentrum für Reise- und Tropenmedizin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Stockholm
country: Sweden
facility: City Akuten Wasa Vaccination
Study officials:
affiliation: Valneva Austria GmbH
name: Andrea Ayad, Dr.
role: STUDY_CHAIR
References: