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

Can the dosage of vaccine against TBE is optimized by means of changes in dosing interval for those over 50 years - 2011-001348-31

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001348-31-SE

Enrollment

250

Registered

2011-04-05

Start date

2011-05-31

Completion date

Unknown

Last updated

2013-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tick-borne Encephalitis MedDRA version: 14.1 Level: LLT Classification code 10043848 Term: Tick-borne viral encephalitis, unspecified System Organ Class: 100000004862

Interventions

Trade Name: FSME-IMMUN Pharmaceutical Form: Suspension for injection Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), STRAIN K23 Concentration unit: µg/ml microgram(s)/millilitre C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if three doses of TBE vaccine is needed first season, when individuals aged 50 years or older are immunized? ;Secondary Objective: Are the same individuals protected against TBE after a booster dose of TBE vaccine next season after initial vaccination ;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). ;Timepoint(s) of evaluation of this end point: day 60 and day 120	—

Measure

Time frame

Main Objective: To evaluate if three doses of TBE vaccine is needed first season, when individuals aged 50 years or older are immunized? ;Secondary Objective: Are the same individuals protected against TBE after a booster dose of TBE vaccine next season after initial vaccination ;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). ;Timepoint(s) of evaluation of this end point: day 60 and day 120

—

Secondary

Measure	Time frame
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) ;Timepoint(s) of evaluation of this end point: day 360	—

Countries

Sweden

Contacts

Public ContactLars Rombo

Mälarsjukhuset

lars.rombo@dll.se+46706404937

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026