No 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.)
Conditions
Interventions
Trade Name: In this trial no IMP will be administered. This trial consists of 3 blood drawals only
Pharmaceutical Form:
Sponsors
Novartis Vaccines and Diagnostics GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate whether the first booster interval after primary vaccination with Encepur agains Tick borne encephalitis can be prolonged from 3 years (current SPC recommendation) to 5 years. Primary objectives: 1. To determine the proportion of study subjects with a TBE neutralizing titer = 10 at 3, 4 and 5 years after completion of the primary immunization. 2. The kinetics of the response over time (at years 3, then 4, then 5) will also be assessed. ;Secondary Objective: 1. To determine the proportion of study subjects with detectable TBE neutralizing antibody response (i.e. NT = 2, the detection limit of the neutralizing assay) at 3, 4 and 5 years after completion of the primary immunization within each group. 2. Descriptive evaluation of levels of TBE-specific binding antibodies as measured by a commercial, validated ELISA (Enzygnost®, Dade Behring) at 3, 4 and 5 years after completion of the primary immunization within each group. 3. Comparative evaluation of antibody responses (NT and ELISA) in subjects having received the first 2 injection with FSME-Immun® Junior vs those having received first 2 injections with Encepur® Children at 3, 4 and 5 years after completion of the primary immunization. ;Primary end point(s): = 85% of study subjects achieve NT titers = 10 (within each group, according to the diffent groups of parent trial) | — |
Countries
Germany
Outcome results
None listed