TBE vaccin in patients using immunosuppressive drugs MedDRA version: 12.1 Level: LLT Classification code 10046859 Term: Vaccination MedDRA version: 12.1 Level: LLT Classification code 10037153 Term: Psoriasis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10054980 Term: Immunosuppressant drug therapy
Conditions
Interventions
Trade Name: FSME-IMMUN
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED)
Concentration unit: µg microgram(s)
Concentration
Sponsors
Mälarsjukhuset Eskilstuna
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed