Japanese Encephalitis (JE) MedDRA version: 14.1 Level: LLT Classification code 10023123 Term: Japanese encephalitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10023120 Term: Japanese B viral encephalitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10023122 Term: Japanese B virus encephalitis System Organ Class: 10021881 - Infections and infestations MedDRA ve
Conditions
Interventions
Trade Name: Ixiaro
Pharmaceutical Form: Suspension for injection
CAS Number: NA
Current Sponsor code: IC51 or IXIARO or JESPECT
Other descriptive name: NA
Concentration unit: µg/ml microgram(s)/millil
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Male or female healthy children and adolescents aged = 2 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1- Clinical manifestation or history of any Flavivirus disease 2- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study 3- Active or passive immunization within 1 week before and 1 week after each IC51 vaccination. 4- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days prior to the first vaccination at Visit 1 5- Immunodeficiency including post-organ-translpantation or a family history of congenital or hereditary immunodeficiency. 6- History of autoimmune disease. 7- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 4 weeks prior to vaccination at Visit 1 and during the study (For corticosteroids, this will mean prednisone, or equivalent, = 0.05 mg/kg/day. Topical and inhaled steroids are allowed). 8- Acute febrile infection at each visit during which the subject receives a vaccination 9- History of hypersensitivity reactions to vaccines 10- Known HIV, HBV or HCV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1- To assess the safety profile of IC51in a pediatric population from regions where JEV is not endemic;Secondary Objective: 1- To assess immunogenicity of the purified inactivated Japanese Encephalitis (JE) vaccine IC51 using the Seroconversion rates (SCRs) and Geometric Mean Titers (GMTs) at Day 56 in a pediatric population from regions where JE is not endemic 2- To assess differences in the immunogenicity and safety profile of IC51 in subjects depending on age groups and dose groups.;Primary end point(s): Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.;Timepoint(s) of evaluation of this end point: after the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of subjects with serious adverse events (SAEs) and medically attended AEs and up to Month 7 after the first vaccination -Rate of subjects with solicited local and systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination - Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7 after the first vaccination - Rate of subjects with abnormal laboratory parameters (hematology, serum chemistry, urinalysis) up to Day 56 and up to Month 7 after the first vaccination - SCRs as defined as percentage of subjects with JEV neutralizing antibody titers of PRNT50 = 1:10 at Day 56 and Month 7, measured using a validated Plaque Reduction Neutralization Test (PRNT) - GMTs for JEV neutralizing antibodies measured using a validated Plaque Reduction Neutralization Test (PRNT) at Day 56 and Month 7 -SCRs and GMTs at Day 56 and Month 7 stratified according to dose groups and age groups ;Timepoint(s) of evaluation of this end point: after the end of the study | — |
Countries
Australia, Denmark, Germany, Sweden, United States
Outcome results
None listed