Safety and tolerability of the Japanese encephalitis vaccine IC51 (JE-PIV). Double blind, randomized, placebo controlled phase 3 study - IC51- 302

Phase 1

• 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: EUCTR2005-000100-14-GB
• Lead Sponsor: Intercell AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-31
• Study Completion: 2006-11-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3475

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 study period and 30 days after the last vaccination 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. 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

Exclusion Criteria

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

Administration of yellow fever vaccine 30 days before or up to 30 days after study treatment

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, more than or equal to 0.5 mg/kg/day. Topical and inhaled steroids, are allowed.)

Any acute infections within 2 weeks prior to enrollment

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

Known or suspected HIV Infection

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)

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