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

Baxter Innovations GmbH0 sites240 target enrollmentJune 17, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Evaluation of Immunogenicity of a TBE (Tick Borne Encephalitis) Vaccine in previously unvaccinated children aged 1 to below 15 years
Sponsor: Baxter Innovations GmbH
Enrollment: 240
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

June 17, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.