COMPARISON OF THREE COMMERCIAL BATCHES OF THE JAPANESE ENCEPHALITIS VACCINE IC51. DOUBLE BLIND, RANDOMIZED, CONTROLLED PHASE 3 STUDY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 384

Inclusion Criteria

- At least 18 years of age
- In female subjects, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception, as specified in protocol Section 6.4
- Written informed consent obtained prior to study entry (subjects should give their consent themselves)

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

Exclusion Criteria

- History of clinical manifestation of any flavivirus infection
- History of vaccination against JE (including study participation in any previous or current IC51 clinical study), Yellow fever and Dengue fever
- 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 preceding the first dose of study vaccine
- Administration of any other vaccine within 4 weeks before randomization and 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 6 months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, >/= 0.05 mg/kg/day. Topical and inhaled steroids are allowed.)
- Any acute infections within 4 weeks prior to randomization
- History of severe hypersensitivity reactions, in particular to a component of the IC51 vaccine (e.g. protamine sulfate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
- Infection with HIV (a negative test result within 30 days before screening is acceptable), HBV (Hepatitis B surface antigen [HBsAg]) or HCV
- 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 approximately 60 g alcohol per day, or conditions which might interfere with the study conduct)
- Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination
- Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, or history of malignancy in the past 5 years
- Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects with child-bearing potential (for details, please refer to Section 6.4)
- Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- Inability or unwillingness to provide informed consent and to abide by the requirements of the study
- Persons who have been committed to an institution (by a court or by an authority) will not participate in 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

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