A phase IV, open-label, multi-center follow-up study to determine the persistence of tick-borne encephalitis (TBE)-specific antibody responses among children and adolescents previously immunized against TBE. - M48P3E1
- Conditions
- o medical condition, healthy volunteers will be recruited.(In this study the status of antibody titers against tick borne encephalitis will be investigated in healthy subjects who have received their primary vaccination in a parent trial in 2006.)
- Registration Number
- EUCTR2009-010145-31-DE
- Lead Sponsor
- ovartis Vaccines and Diagnostics GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Healthy M48P3 study subjects with parental or legal guardian informed consent (health status as determined by review of medical history and physical examination and in the clinical judgment of the investigator)
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
•Subjects who did not receive complete schedule of primary vaccination in M48P3.
•Subjects enrolled in other investigational studies at the same time and within the last three months
•Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method