Active (prophylactic) immunization against tick-borne encephalitis MedDRA version: 20.1 Level: PT Classification code 10043847 Term: Tick-borne viral encephalitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: TicoVac 0.5 mL
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: J07 BA01
CAS Number: 8000029723
Current Sponsor code: PF-06830414
Other descriptive
Sponsors
Riga Stradinš University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects age 1 year and older 2. Subject/ parent (s)/ legal guardian(s) provide(s) written informed consent according to national law 3. Subject provides written assent to the study according to local law, age, and capacity of understanding if applicable 4. Subject/ parent (s)/ legal guardian(s) understand(s) the nature of the study and is/are willing to comply with the requirements of the protocol (e.g., return for all visits) Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. History of infection with or vaccination against a flavivirus (e.g., TBE, Dengue, Yellow Fever, Japanese B Encephalitis, West Nile) 2. Contraindication to TBE vaccination per the SmPC 3. Pregnant or lactating females and all breastfed young children (at any time prior to completion of the primary vaccination series [first 3 doses]} 4. Females of childbearing potential who do not agree to using at least an acceptable birth control method (See Section 9.4) from 28 days before the first vaccination until 28 days after the last vaccination in the study 5. Not clinically healthy (i.e., physician would have reservations in vaccinating with a TBE vaccine outside the scope of this study) 6. Suffering from a disease or have undergone any treatment such as corticosteroids or immunosuppressants that could influence immunological functions within 28 days prior to study start or during the study 7. Surgery requiring hospitalization within 28 days of study start or planned surgery during the study that would require an immunomodulating treatment 8. Severe medical condition requiring hospitalization within 3 months of study start or during the study 9. Malignancy within 5 years of study start 10. Known or suspected substance abuse disorder or mental disability 11. Received any other vaccine within 28 days of study start through 28 days after the second vaccination or 28 days before through 28 days after the third vaccination 12. Received blood, blood fractions, plasma, or immunoglobulins within 3 months of study start and during the study 13. Participation in another clinical trial involving receipt of an investigational product within 1 month of study start or during study 14. Investigator, site staff members directly involved in the conduct of the study, or site staff members otherwise supervised by an Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the immune response induced by FSME-IMMUN/TicoVac or Encepur against two virus strains Neudorfl (Nd) used to manufacture FSME/IMMUN/TicoVac and mutated Karsruhe (mK23) (one homologous strain and one heterologous strain to each vaccine), as measured by NT using an established hybrid virus assay platform.;Secondary Objective: To describe the immune response induced by FSME-IMMUN/TicoVac or Encepur against the vaccine virus strains (Neudorfl (Nd) used to manufacture FSME/IMMUN/TicoVac and the mutated Karsruhe strain (mK23) used to manufacture Encepur), as measured by ELISA (IMMUNOZYM and ENZYGNOST).;Primary end point(s): The primary endpoint for the primary objective is the %composite response of neutralizing titers against both homologous and heterologous antigens to the vaccines at each visit. The composite response is defined as a subject with NT==10 for both Nd and mK23.;Timepoint(s) of evaluation of this end point: End of Trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint for the primary objective will include: • % of subjects with NT =10 for Nd; • % of subjects with NT >10 for mK23; • % of subjects with NT >20 for Nd, mK23, and for both Nd and mK23; • GMT for Nd; • GMT for mK23. The secondary endpoint for the primary objective will include: • %of subjects with ELISA >126 for Nd • %of subjects with ELISA >126 for mK23 • GMC for Nd • GMC for mK23 ;Timepoint(s) of evaluation of this end point: End of Trial | — |
Countries
Latvia
Contacts
Public ContactClinical Trial Information Desk
Riga Stradinš University
Outcome results
None listed