COMPARISON OF THREE BATCHES OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (JE-PIV). DOUBLE BLIND, RANDOMIZED, CONTROLLED PHASE 3 STUDY.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 624

Inclusion Criteria

-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 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 Japanese encephalitis (incl. study participation in any
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 another 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 six 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 sulphate), 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), 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)
-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, 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate equivalence of three IC51 (JE-PIV) batches in terms of Geometric<br>Mean Titers (GMT) for anti-JEV neutralizing antibody.;Secondary Objective: -To assess the seroconversion rates of three IC51 (JE-PIV) batches<br>-To investigate the safety of three IC51 (JE-PIV) batches during a vaccination period of 28 days until 6 months after the first vaccination<br>-To investigate tolerability of three IC51 (JE-PIV) batches during a vaccination period<br>of 28 days until 4 weeks after the last vaccination<br>-To analyze the rates of serious adverse events and medically attended adverse eventsin individuals after immunization with IC51 (JE-PIV)<br>-To assess possible changes in laboratory parameters.;Primary end point(s): Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody at day 56

Secondary Outcome Measures

Name	Time	Method

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