EFFECT OF A BOOSTER DOSE OF THE JAPANESE ENCEPHALITIS VACCINE IC51 ON LONG TERM IMMUNOGENICITY. AN UNCONTROLLED, OPEN-LABEL PHASE 3 STUDY.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

-At least 18 years of age
-Subjects correctly included in and having completed study IC51 309 (i.e. received both IC51 vaccinations within the accepted time windows and completed all visits including the 6-months follow-up) without having any major protocol violations
-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 (except IC51 administered in study IC51-309), Yellow fever, Dengue fever and West e virus
•Use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC51 vaccination at Visit 1 and during the study period
•Administration of any vaccine within 4 weeks prior to IC51 vaccination at Visit 1
•Administration of a vaccine (except the study vaccine) against a flaviviral infection, e.g. JE, tick-borne encephalitis (TBE), Yellow fever, Dengue fever or West e virus during the study
•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 4 weeks prior to IC51 vaccination at Visit 1 and during the study. (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 vaccination at Visit 1
•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 involuntarily to an institution, e.g. mental health facility or prison, 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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