Observer blinded, randomized Phase III study to investigate the non-inferiority of IC51 (JE-PIV) vs. JE-VAX as vaccines for japanese encephalitis in healthy volunteers - IC51-301
- Conditions
- Japanese encephalitis (JE) is the most common viral encephalitis, with over 50,000 cases reported annually. It is a considerable public health problem for many Asian countries (WHO 1997). Close to 3 billion people now live in regions at risk for the disease, particularly in rural areas where JE occurs sporadically in epidemics of variable magnitude. Vaccination against JE remains the single most important control measure worldwide.
- Registration Number
- EUCTR2004-002474-36-AT
- Lead Sponsor
- Intercell AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 858
- At least 18 years of age
- In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception as specified in section 6.4
- Written informed consent obtained prior to study entry (subjects should give their consent themselves. Consent by legal representatives is allowed.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
- History of clinical manifestation of any flavivirus infection
- History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer ³ 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- Planned administration of another vaccine during the study period
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Topical and inhaled steroids are allowed.)
- Any acute infections within 4 weeks prior to enrollment
- History of severe hypersensitivity reactions, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
- Infection with HIV (a negative test result within 30 days before enrollment is acceptable), Hepatitis B (HBsAg) or Hepatitis C
- History of urticaria after hymenoptera envenomation, drugs, physical or other provocations, or of idiopathic cause
- Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approx. 60 g alcohol per day, or conditions which might interfere with the study conduct)
- Known hypersensitivity to thimerosal
- Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, history of malignancy in the past 5 years
-Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects (for details please refer to protocol section 6.4)
- Inability or unwillingness to provide informed consent and to abide by the requirements of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method