Healthy adult volunteers (2 age-groups: 18-60 years and >60 years old) are vaccinated in order to achieve protection against influenza virus infection with the vaccine containing the influenza virus strains recommended by WHO for the 2010-2011 season in the Northern Hemisphere
Conditions
Interventions
Trade Name: Vaccin gripal trivalent purificat si inactivat
Product Name: Vaccin gripal trivalent purificat si inactivat
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hemagglutinin
Sponsors
Cantacuzino National Institute of Research and Development for Microbiology and Immunology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Able to give the written informed consent Able to understand and to follow all the phases and the procedures of this study Age 18-60 or >60 years and haven't been vaccinated against influenza in the previous year Availability for all the visits of this study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy to eggs Allergy to thyomersal Guillain-Barre syndrome in personal records Less than 30 days from the participation or present inclusion in another clinical trial Receiving parenteral Immunoglobulins in the 30 days previous to assessment for the inclusion in the study Pregnant or nursing Non-compensated diseases Fever or other symptoms that may cause confusion with postvaccinal reactions Autoimmune disease, immunodeficiency Immunosupressant treatment: corticoids, chemotherapy, radiotherapy Drugs or alcohol abuse HIV, Treponema pallidum, TBC, HBV, HCV infection Contagious disease contact in personal records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the immunogenity and reactogenity of the influenza vaccine produced by Cantacuzino National Institute of Research and Development for Microbiology and Immunology for the 2010-2011 season according to WHO recommendations in a population of adult healthy volunteers;Secondary Objective: Assessment of the safety profile of the vaccine in the 18-60 and in the >60 years old groups Assessment of compliance with CPMP/EWP/1045/01 regulations operating for the influenza vaccine;Primary end point(s): Assessment of the immunogenity and reactogenity of the Influenza trivalent purified inactivated vaccine for parenteral use produced by Cantacuzino National Institute of Research and Development for Microbiology and Immunology according to WHO recommendations for the 2010-2011 season, in a population of adult healthy volunteers | — |
Countries
Romania
Outcome results
None listed