Can the dosage of vaccine against TBE is optimized by means of changes in dosing interval for those over 50 years

Conditions: Tick-borne Encephalitis
MedDRA version: 14.1Level: LLTClassification code 10043848Term: Tick-borne viral encephalitis, unspecifiedSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-001348-31-SE

Lead Sponsor: Mälarsjukhuset

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 250

Inclusion Criteria

• Patients who want protection against TBE
• Patients who have submitted 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Previously had TBE
• Previous vaccination with TBE vaccine
• Hypersensitivity or allergy to eggs.
• Ongoing disease that affects the immune system
• 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).
• Known hypersensitivity to the active substance or any of the excipients.

TBE vaccination should be postponed if the person has an acute ongoing infection with fever.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if three doses of TBE vaccine is needed first season, when individuals aged 50 years or older are immunized?<br>;Secondary Objective: Are the same individuals protected against TBE after a booster dose of TBE vaccine next season after initial vaccination<br>;Primary end point(s): Level of neutralizing antibodies against TBE one month after dose 2 = day 60 (group 1 + younger control group) and one month after dose 3 = day 60 and day 120 (group 2 +3).<br>;Timepoint(s) of evaluation of this end point: day 60 and day 120

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Level of neutralizing antibodies prior to dose 3 = day 360 day (group 1 + younger control group) or 4 doses (group 2 and 3)<br>;Timepoint(s) of evaluation of this end point: day 360