FSME (human tick-borne encephalitis) - vaccination in children after thymectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002647-27-AT

Enrollment

100

Registered

2005-02-21

Start date

2005-03-10

Completion date

Unknown

Last updated

2022-01-04

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

Conditions

In children who undergo open heart surgery because of heart vitium, for surgical reasons the thymus has to be removed. If thymectomy in early childhood alters the function of the immunsystem has been discussed controversially.

Interventions

Trade Name: FSME-IMMUN 0,25 ml Junior Frühsommer-Meningoenzephalitis (FSME) Virus - Impfstoff Product Name: FSME-IMMUN 0,25 ml Junior Pharmaceutical Form: Suspension for injection Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients after thymectomy in the setting of heart-lung-machine-surgeries because of heart vitium will be recruited. Healthy sex- and age-matched control persons from local kindergartens and schools will be recruited. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: heart transplantation acute cyanotic vitium therapy with immunosuppressive or cytostatic drugs therapy with glucocorticoids therapy with drugs, influencing the immune system infection (acute or 2 weeks ago) allergy (minor forms of allergic rhinitis only acute manifestation) DiGeorge syndrome, other syndromes

Design outcomes

Primary

Measure	Time frame
Main Objective: In our study, after initial FSME-antibody titer determination (serum, from cubital vein, 3 ml), patients and controls will be immunized with 0,25 ml FSME-IMMUN „NEW“, Baxter (1,2µg TBE Antigen/0,25 ml) (intramuscular, left M. deltoideus or children younger than 18 months left M. vastus lateralis). 5 weeks later they will get the second immunization. The second blood sample (serum, from cubital vein, 3 ml) will be taken 5 weeks after the second immunization to evaluate the antibody titer increase. Main objective of the trial is the increase of the FSME-antibody levels in thymectomized children compared to healthy controls without thymectomy. ;Secondary Objective: reactions to vaccination;Primary end point(s): FSME-antibody titers > 60 I.U. in the first serum sample severe side effects after first vaccination	—

Measure

Time frame

Main Objective: In our study, after initial FSME-antibody titer determination (serum, from cubital vein, 3 ml), patients and controls will be immunized with 0,25 ml FSME-IMMUN „NEW“, Baxter (1,2µg TBE Antigen/0,25 ml) (intramuscular, left M. deltoideus or children younger than 18 months left M. vastus lateralis). 5 weeks later they will get the second immunization. The second blood sample (serum, from cubital vein, 3 ml) will be taken 5 weeks after the second immunization to evaluate the antibody titer increase. Main objective of the trial is the increase of the FSME-antibody levels in thymectomized children compared to healthy controls without thymectomy. ;Secondary Objective: reactions to vaccination;Primary end point(s): FSME-antibody titers > 60 I.U. in the first serum sample severe side effects after first vaccination

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Countries

Austria

Outcome results

None listed

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