IXIARO® is used to protect adults against Japanese encephalitis (JE). JE can be fatal or lead to long-term disability. Vaccination with Ixiaro should be considered for people who are at risk of exposure to the JEV through travel or work. A post-marketing requirement was to collect more safety and immunogenicity data in elderly, therefore this study is to be performed in healthy volunteers = 65 years of age. MedDRA version: 12.1 Level: LLT Classification code 10014596 Term: Encephalitis Japanese
Conditions
Interventions
Trade Name: IXIARO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Japanese Encephalitis Vaccine (inactivated)
Current Sponsor code: IC51
Other descriptive name: JAPANESE ENCEPHALIT
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects = 65 years of age at the time of 1st vaccination of good general health status including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, cardiovascular disease or non-insulindependent diabetes mellitus 2. Weight: = 45.5 kg and = 150 kg at Visit 0 (Screening Visit) 3. White blood cells =2,500/mm3 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of clinical manifestation of any flavivirus infection (Yellow Fever, Dengue Fever, JE, Tick Borne Encephalitis (TBE) and West Nile Fever/Neuroinvasive Disease) 2. Vaccination against JE (including study participation in any previous or current IC51/IXIARO® clinical study), Yellow fever, Dengue Fever or West Nile Fever at any time prior or during the study 3. Vaccination against TBE within 30 days prior to first IXIARO® vaccination at Visit 1 (Day 0) and until Visit 3 (Day 70) 4. Use of any other investigational or non-registered medicinal product within 30 days prior to IXIARO® vaccination at Visit 1 (Day 0) and throughout the entire study period 5. Immunodeficiency including status post-organ-transplantation or immunosuppressive therapy, and a family history of congenital or hereditary immunodeficiency 6. Infection with the human immunodeficiency virus (HIV, a negative test result within 30 days before screening is acceptable), Hepatitis B virus (HBV, Hepatitis B surface antigen [HBsAg]) or Hepatitis C virus (HCV) 7. Administration of chronic (defined as longer than 14 days) immunosuppressants or other immune-modifying drugs within 30 days prior to IXIARO® vaccination at Visit 1 (Day 0) and during the study until Visit 3 (Day 70). (For corticosteroids this means prednisone or equivalent = 0.05 mg/kg/day; topical and inhaled steroids are allowed). 8. Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to first IXIARO® vaccination at Visit 1 (Day 0) and until Visit 3 (Day 70) 9. History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded. 10. Acute febrile infections or exacerbation of chronic infection on the day of IXIARO® vaccination (Day 0 and Day 28) 11. Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders, which are not adequately controlled by medical treatment within the last 12 weeks before IXIARO® vaccination at Visit 1 (Day 0) as judged by the site`s Principal Investigator 14 Clinically significant mental disorder not adequately controlled by medical treatment 15 History of Guillain-Barré-Syndrome (GBS). 16 History of severe hypersensitivity reactions, in particular to a component of the IXIARO® vaccine (e.g. protamine sulfate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile of the purified inactivated JE vaccine IXIARO® in an elderly (= 65 years of age) population;Secondary Objective: - To assess the immunogenicity of the purified inactivated JE vaccine IXIARO® in an elderly population using seroconversion rates (SCRs*) at Day 70 - To assess the immunogenicity of the purified inactivated JE vaccine IXIARO® in an elderly population using the Geometric Mean Titers (GMTs) for JEV neutralizing antibodies determined by PRNT at Day 70 * SCR is defined as the rate of subjects with a plaque reduction neutralization test (PRNT)** titer of = 1:10. **The PRNT50 titer is defined as the highest serum dilution showing a 50% reduction of plaque counts.;Primary end point(s): Rate of subjects with serious adverse events (SAEs) and medically attended adverse events (AEs) during the vaccination period and until Day 70 after the first vaccination. | — |
Countries
Austria, Germany
Outcome results
None listed