Vaccination against TBE in patients who use immunosuppressive drugs

• Conditions: TBE vaccin in patients using immunosuppressive drugs; MedDRA version: 12.1Level: LLTClassification code 10046859Term: Vaccination; MedDRA version: 12.1Level: LLTClassification code 10037153Term: Psoriasis; MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis; MedDRA version: 12.1Level: LLTClassification code 10054980Term: Immunosuppressant drug therapy

• Registration Number: EUCTR2010-019438-28-SE
• Lead Sponsor: Mälarsjukhuset Eskilstuna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients treated with immunosuppressive medication for treatment of rheumatoid arthritis (RA) or Psoriasis and desiring protection against TBE
• Men and women 18 years or older.
• Signed informed consent
• Women of childbearing age must use a safe method of contraception such as oral contraceptives or abstinence during the study period.
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

• Previous TBE infection
• Previous vaccination with TBE vaccine
• Hypersensitivity or allergy to eggs.
• Treatment with rituximab within the last 9 months before inclusion
• Pregnant or lactating
• If the investigator for any other reason considers the patient unsuitable for inclusion. For example, in the presence of some other serious disease (eg AIDS / HIV positive, ongoing cancer chemotherapy).
• Hypersensitivity to the active substance or any of the excipients.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Are patients using immunosuppressive drugs protected against TBE after two doses of TBE vaccine (three doses for patients over 60 years)?;Secondary Objective: Are patients using immunosuppressive drugs protected against TBE after booster dose the following season (After the third TBE vaccine dose for patients < 60 years old and after the forth TBE vaccine dose for patients =60 yeras old).;Primary end point(s): Serum Concentration of TBE antibodies.