The Study of the Immunogenity and Reactogenity of Trivalent, Purified, Inactivated Influenza Vaccine for Parenteral Administration in Adults, for the 2010-2011 Season, Produced by Cantacuzino National Institute of Research and Development for Microbiology and Immunology
- Conditions
- 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 Hemispherethe immunogenity and reactogenity of the vaccine are assessed
- Registration Number
- EUCTR2010-023105-35-RO
- Lead Sponsor
- Cantacuzino National Institute of Research and Development for Microbiology and Immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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
- Secondary Outcome Measures
Name Time Method