Healthy volunteers (Active immunization in individuals from 12 years of age against tick-borne encephalitis (TBE) virus. The vaccination is intended for residents or travellers in TBE-endemic areas, according to national recommendations).
Conditions
Interventions
Trade Name: ENCEPUR ADULTS (Encepur Erwachene)
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: -
Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIV
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for all subjects: -Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. -Written informed consent obtained from the subject prior to performance of any study specific procedure. -Subjects who have participated in study V48P7E2 (NCT01562444) and who received in the parent V48P7 study one of the following schedules: rapid, conventional, or accelerated conventional and a booster vaccination in study V48P7E1 (NCT00387634) or before study V48P7E1 (NCT00387634) (only rapid schedule) Additional inclusion criteria for subjects who will need a second booster dose: -Healthy subjects as established by medical history and clinical examination before entering into the study. -Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. - Female subjects of childbearing potential can receive the booster vaccine in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after booster administration. 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 163 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: Each subject must not be: - Unwilling or unable to give written informed consent to participate in the study. - Perceived to be unreliable or unavailable to complete the study. Each subject must not have: -Clinical conditions representing a contraindication to blood draws. -Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. -Received an investigational or non-registered medicinal product within 30 days prior to informed consent. -Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product). -Levels of NT<10 in V48P7E2 (NCT01562444) study. -Previous vaccination against TBE or other Flavivirus diseases with other TBE and Flavivirus vaccines (e.g. Yellow fever vaccine, Dengue fever vaccine, Japanese encephalitis vaccine) before, during and after completion of the V48P7E2 (NCT01562444) and before starting TBEV POLYGELINE FREE-025 EXT 21 study. -Primary immunization with TBE vaccine in the parent study V48P7 according to the modified conventional (MC) schedule. -History of confirmed TBE infection. -Known exposure to other Flaviviruses. Each subject who will receive the second booster vaccination in this study additionally to the exclusion criteria above must not have: -Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. -Clinical conditions representing a contraindication to intramuscular vaccination. -Progressive, unstable or uncontrolled clinical conditions. -Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent. This will mean prednisone =20 mg/day (for adult subjects) or equivalent. Inhaled and topical steroids are allowed. Administration of antineoplastic and immuno-modulating agents or radiotherapy within 90 days prior to vaccination. -Received immunoglobulins or any blood products within 180 days prior to vaccination. -Administration of long-acting immune-modifying drugs at any time during the study period. -Acute disease and/or fever at the day of booster vaccination. -Expected general decrease in immune response. -Organic brain disturbances, including seizure disorders. -Progressive neurological disorders. -Suffered febrile or afebrile convulsions. -Serious chronic illness. -History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or chemically related substances. -Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccines. -Pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the persistence of antibody response to a booster dose of Encepur Adults vaccine starting = 11 years after the first booster administration and to continue following subjects up to 15 years after first booster administration.;Secondary Objective: To evaluate the immune response at 21 days after booster dose (boostability) in subjects with an NT titre below 10. To evaluate the safety of a booster dose with regard to SAEs collected after vaccination until study end. ;Primary end point(s): Percentages of subjects with detectable TBE Neutralizing Antibody Titres = 2 and = 10 as measured by GSK Bio-logicals’ NT. Geometric Mean Antibody Titres as measured by GSK Biologicals’ NT calculated for each of the different schedule groups. This endpoint will be summarized according to the immunization schedule received in the V48P7E1 (NCT00387634) study and further detailed by the following age subgroups: 25 to 49 years, = 50 years and = 60 years.;Timepoint(s) of evaluation of this end point: Year 11, Year 12, Year 13, Year 14, Year 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 21 days after the booster vaccination. For SAEs: At 1 month after vaccination. Based on the timing of the booster dose, at Years 11.5 (Visit 23.1), 12.5 (Visit 24.1), 13.5 (Visit 25.1), or 14.5 (Visit 26.1) or from year 15.5 (Visit 27.1) until 21 days after year 15.5 (Visit 27.2);Secondary end point(s): Percentages of subjects with detectable TBE Neutralizing Antibody Titres = 2 and = 10 as measured by GSK Bio-logicals’ NT, overall and by study group. Geometric Mean Antibody Titres and Geometric Mean Ratios (GMRs) blood draw after/before booster as meas-ured by GSK Biologicals’ NT, overall and by study group. Thorough description of NT waning in order to complement the analysis of persistence. To complement the analysis of persistence, a thorough description of NT waning from year 1 after the first booster dose up to 15 years will be presented for the set of subjects completing the entire 15-year follow-up with no protocol deviations, including those receiving a second booster dose; for whom, a constant value of NT = 1 from the post booster visit will be used in the analysis This endpoint will be summarized according to the primary immunization schedule received in the parent study (V48P7). Incidence of serious adverse events (SAEs). The safety endpoint for subjects who will need a second booster vaccination will be based on SAEs collection after the second booster dose. SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disabil-ity/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | — |
Countries
Czech Republic
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed