Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule with FSME-IMMUN 0.25 ml JUNIOR in Healthy Children aged 3 - 15 Years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000810-35-CZ

Enrollment

300

Registered

2007-03-27

Start date

2007-04-19

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Prevention of Tick-born encephalitis (TBE). The rapid immunization schedule recommended in the current SPC for FSME-IMMUN 0.5 ml (Day 0, Day 14) has been used in Austria for 20 years. FSME-IMMUN 0.25 ml was first administered in clinical trials in the year 2001 and the rapid immunization schedule is recommended for children ranging 1 to 16 years of age. However, limited data on immunogenicity when using the rapid immunization schedule in children exist. MedDRA version: 9.1 Level: LLT Classifica

Interventions

Trade Name: FSME-IMMUN 0,25 ml Baxter Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - the written informed consent of their parents / legal guardians - with their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) - aged > 3 years (from the 3rd birthday) to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - history of any previous TBE vaccination; - history of TBE infection or other flaviviruses; - history of vaccination against yellow fever and/or Japanese B-encephalitis; - history of allergic reactions, in particular to one of the components of the vaccine; - suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions; - blood transfusion or immunoglobulins within one month of study entry; - known HIV positivity (an HIV test is not required) - simultaneously participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate immunogenicity after vaccination with FSME-IMMUN 0.25 ml JUNIOR using a rapid immunization schedule by means of ELISA and NT.;Secondary Objective: To evaluate safety after vaccination with FSME-IMMUN 0.25 ml JUNIOR using a rapid immunization schedule.;Primary end point(s): - Seropositivity rate as determined by ELISA and NT separately at day 21 after the second vaccination	—

Measure

Time frame

Main Objective: To evaluate immunogenicity after vaccination with FSME-IMMUN 0.25 ml JUNIOR using a rapid immunization schedule by means of ELISA and NT.;Secondary Objective: To evaluate safety after vaccination with FSME-IMMUN 0.25 ml JUNIOR using a rapid immunization schedule.;Primary end point(s): - Seropositivity rate as determined by ELISA and NT separately at day 21 after the second vaccination

—

Countries

Czech Republic

Outcome results

None listed

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