Immune response to intradermally administered Ixiaro in healthy adults

• Conditions: 18-64 years old volunteers with general good health

• Registration Number: EUCTR2013-001954-88-FI
• Lead Sponsor: Helsinki University Centrel Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-21
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Male or female subjects aged 18-64
2. General good health as established by medical history and physical examination
3. Written informed consent
4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
5. Available for all visits scheduled in this study.
6. No previous Japanese encephalitis vaccination

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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous Japanese encephalitis vaccination
2. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
4. Pregnancy or lactation
5. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C).
6. Alcohol or drug abuse
7. Suspected non-compliance
8. Use of any investigational drug or any investigational vaccine within 30 days preceding the study vaccine, or planned use during the study period
9. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
10. Employee at the investigational site, relative or spouse of the investigator
11. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified