AN OPEN-LABEL, UNCONTROLLED PHASE 4 STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS (JE) VACCINE IXIARO® (IC51) IN AN ELDERLY POPULATION - IC51-315

• Conditions: 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: 12.1Level: LLTClassification code 10014596Term: Encephalitis Japanese B; MedDRA version: 12.1Level: LLTClassification code 10023119Term: Japanese B encephalitis; MedDRA version: 12.1Level: LLTClassification code 10023120Term: Japanese B viral encephalitis; MedDRA version: 12.1Level: LLTClassification code 10023122Term: Japanese B virus encephalitis; MedDRA version: 12.1Level: LLTClassification code 10023123Term: Japanese encephalitis

• Registration Number: EUCTR2010-018630-52-DE
• Lead Sponsor: Intercell AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 <11,000/mm3 at Visit 0
4. Absolute neutrophil count within normal limits at Visit 0
5. Platelets within normal limits at Visit 0
6. Written informed consent obtained from the subject prior to any study-related
procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of clinical manifestation of any flavivirus infection (Yellow Fever, Dengue
Fever, JE, Tick Borne Encephalitis (TBE) and West e 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 e 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified