No medical condition, healthy subjects.
Conditions
Interventions
Trade Name: Encepur, adults
Pharmaceutical Form: Suspension for injection
Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), STRAIN K23
Concentration unit: µg microgram(s)
Concentra
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. subjects who signed informed consent form (ICF) prior to study entry 2. subjects who have completed study V48P7E1 and who received in a parent V48P7 study one of the following schedules: rapid (R), conventional (C), or accelerated conventional (AC). 3. subjects who are in stable 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 201 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. who are unwilling or unable to give written informed consent to participate in the study. 2. who are perceived to be unreliable or unavailable for the duration of the study period. 3. who has NT titer below 10 before visit 17 (first study visit within this protocol). 4. who has received a TBE or other flavivirus vaccine after completion of the V48P7E1 and before starting V48P7E2 study. 5. who had a previous confirmed TBE infection or were exposed (documented infection) to other flaviviruses. 6. who received in the parent V48P7 study a primary immunization according to the modified conventional (MC) schedule. 7. who have received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. 8. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study. 9. who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 10. who have chronic immunosuppressive conditions 11. who have been treated with: - immunosuppressants or systemic corticosteroids within the past 4 weeks or during the study period, except short term use of topical corticosteroids - immunoglobulins, whole blood or plasma derivatives up to 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the persistence of antibody response to a booster vaccine starting 6 years after the booster administration and following subjects up to 10 years after first booster administration. ;Secondary Objective: not applicable;Primary end point(s): ? Percentages of Subjects with detectable TBE Neutralizing Antibody Titers = 2 and = 10 as measured by NVD NT assay ? Geometric Mean Antibody Titers and Geometric Mean Ratios (GMRs) as measured by NVD NT assay calculated for each of the different schedule groups;Timepoint(s) of evaluation of this end point: The immunogenicity endpoints will be evaluated at year 6, 7, 8, 9 and 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No | — |
Countries
Czech Republic
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals S.A.
Outcome results
None listed