A phase IV, randomized, open-label, multi-center study in adults: Evaluation of long-term immunogenicity in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer) in study V48P2E1, 5 years after first booster immunization and Evaluation of booster kinetics in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer), 5 years after first booster immunization. - not available

Chiron Behring GmbH & Co KG0 sites190 target enrollmentNovember 7, 2005

Overview

No summary available.

Registry

who.int

Start Date

November 7, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Chiron Behring GmbH & Co KG

•·Healthy volunteers of both sexes aged \>18 who participated in study V48P2E2 and are willing to give informed consent will be included.
•·Subjects who are available for the duration of the trial (approximately 3 weeks)
•·Subjects who are in good health as determined by medical history, physical examination, and clinical judgment of the investigator
•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
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•·Subjects not willing to sign the informed consent form
•·Subjects with documented evidence of TBE
•·Subjects who receive another vaccine within the 4 weeks before the administration of investigational product and 3 weeks after
•·Subjects with acute disease at the day of enrollment (acute disease means moderate or severe illness with or without fever; vaccine can be administered to subjects with minor illness such as mild diarrhea or mild upper respiratory tract infection with body temperature \< 38\.0°C)
•·Subjects with organic brain disturbances, including seizure disorders
•·Subjects with progressive neurological disorders
•·Subjects who have suffered febrile or afebrile convulsions
•·Subjects in whom a general decrease in resistance might be expected, e.g. those who have recently sustained severe injury or undergone recent surgical operations or in whom surgical operations are planned during the study period, are undernourished, or have disorders involving a decreased immune response
•·Subjects being treated with immunosuppressants, systemic corticosteroids for longer than 2 months within the past 4 weeks or during the study period, except for topical or inhaled therapy of mild bronchial asthma
•·Subjects being treated with immunoglobulins, whole blood or plasma derivates within the last 3 months and during study participation