healthy subjects eligible for tetanus booster vaccination
Conditions
Interventions
Trade Name: Tetanol pur vakcina fecskendoben
Product Name: TETANOL PUR
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
Plazmaferezis Állomás Közhasznú Nonprofit Kft
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 21-65 years old eligible for plasmadonation at least 2 times given plasma eligible for Tetnus revacination accepted ICF 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 480 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: not eligible for regular plasmadonation suffer a serius medical condition such as CND, coagulatopathy, chronic diseases, diabetes, HCV, HB HIV, and others)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of plasmapheresis on tetanus titer by booster tetanus vaccination;Secondary Objective: changes of tetanus titer during the repeated plasmadonation by course of the study;Primary end point(s): changes in tetanus antibody titer after regular palsma donation;Timepoint(s) of evaluation of this end point: repeated in 1-3-6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): side effects adverse events during teh course of the study;Timepoint(s) of evaluation of this end point: 30-90 -120days | — |
Countries
Hungary
Contacts
Public Contactreguulatory dept
Human Biplazma Kft
Outcome results
None listed