IMMUNOGENICITY OF A COMMERCIAL BATCH OF THE JAPANESE ENCEPHALITIS VACCINE IC51 UP TO TWENTY-FOUR MONTHS POST FILLING, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY
- Conditions
- Japanese Encephalitis (JE)MedDRA version: 9.1Level: PTClassification code 10014596Term: Encephalitis Japanese B
- Registration Number
- EUCTR2008-004634-24-DE
- Lead Sponsor
- Intercell AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
-Male and female healthy adults
-Aged at least 18 years
-With written informed consent obtained prior to study entry (subjects could give their consent themselves)
-In female subjects, either no childbearing potential or negative serum pregnancy test and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception or childbearing potential terminated by surgery or 1 year post-menopausal
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
-Use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC51 vaccination and during the study period
-Vaccination against JE (including study participation in any previous or current IC51 clinical study), Yellow fever, Dengue fever or West e virus at any time prior or during the study
-Administration of a vaccine against tick-borne encephalitis (TBE) between IC51 vaccination at Visit (Day 0) and Visit 3 (Day 56)
-History of immunodeficiency or immunesuppressive therapy
-Infection with HIV (a negative test result within 30 days before screening is acceptable), HBV (Hepatitis B surface antigen [HBsAg]) or HCV
-Acute infections or exacerbation of chronic infection within 4 weeks prior to IC51 vaccination at Visit 1 requiring specific treatment
-Drug addiction within 6 months prior to Visit 0 (including alcohol dependence)
-Pregnancy (positive pregnancy test during screening or at Visit 1), lactation or unreliable contraception in female subjects with child-bearing potential
-History of severe hypersensitivity reactions, in particular to a component of the IC51 vaccine
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