Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule with FSME-IMMUN 0.25ml JUNIOR in Healthy Children aged 1 to below 15 Years - Pediatric Rapid TBE Immunization Study

• Conditions: Evaluation of Immunogenicity of a TBE (Tick Borne Encephalitis) Vaccine in previously unvaccinated children aged 1 to below 15 years; MedDRA version: 12.1Level: LLTClassification code 10043847Term: Tick-borne viral encephalitis

• Registration Number: EUCTR2010-020097-42-AT
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

•Subject is = 1 year (from the 1st birthday) to below 15 years (to the last day before the 15h birthday) old at the time of screening;
• Subject’s parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
• Subject provides written assent to the study according to age and capacity of understanding;
• Subject / parent(s) / guardian(s) understand(s) the nature of the clinical study and is / are willing to comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
• Subject is generally healthy (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
• If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to the first vaccination and agrees to employ adequate birth control measures for the duration of the study;
• Subject is physically and mentally capable of participating in the study.
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

• Subject has a history of any previous TBE vaccination or infection;
• Subject has a history of infection with other flaviviruses;
• Subject has a history of vaccination against Yellow fever and/or Japanese B encephalitis;
• Subject has a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;
• Subject has a disease (e.g. autoimmune disease) or is undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
• Subject has received any blood product or immunoglobulins within 90 days prior to study entry;
• Subject has a history of testing positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study;
• Subject has a functional or surgical asplenia;
• Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating;
• Subject or one of subject’s parent(s) / legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site personnel conducting the study.
• If female, subject is pregnant or lactating at the time of study enrollment.
• Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the immunogenicity of FSME-IMMUN 0.25ml Junior administered according to a rapid immunization schedule in children aged 1 to below 15 years.;Secondary Objective: Evaluate the safety of FSME-IMMUN 0.25ml Junior administered according to a rapid immunization schedule in children aged 1 to below 15 years.;Primary end point(s): • Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination.