Primary TBE vaccination for the elderly

Phase 1

• Conditions: Immune response to TBE vaccination; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-002541-37-SE
• Lead Sponsor: Region Örebro län

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

? Adults = 50 år or between 18-40 years
? Women and men
? Good health
? Written consent to participate in the study
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

? Previous vaccination against TBE
? Previous TBE infection
? Allergy or hypersensitivity to any substance in the vaccine
?Previously known or suspected infection with Japanese encephalitis, Dengue virus, West e fever or Yellow fever
? Information on previous vaccination against Yellow fever or Japanese encephalitis
? Acute illness, eg fever with malaise
? Immunosuppression, due to medication or disease
? Previous treatment with Rituximab or equivalent
? Autoimmune diseas, including diabetes (diet or tablet-treated diabetes with good metabolic control is accepted, HbA1c < 6 %)
? Obesity, BMI > 40
? Moderate to severe renal failure including hemodialysis, estimated GFR < 30.
? Blood transfusion or immunoglobulins <3 months ago
? Pregnancy
? Any other illness where the investigator consider the subject unsuitable for the study
? The study subject does not want to participate

Study & Design

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