Open Immunization Study to Determine the Reactogenicity and Immunogenicity of Fluarix/ Influsplit SSW 2005/2006 in Persons as of 18 Years of Age - Flu-061
- Conditions
- Immunization against Influenza in healthy male and female subjects aged over 18 years
- Registration Number
- EUCTR2005-001555-38-DE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.A male or female aged 18 years of age at the time of the vaccination, not vaccinated against influenza in the previous season.
2.Written informed consent obtained from the subject.
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
3.Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
4.Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral/axillary temperature < 37.5°C.
5.Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
6.Pregnant female.
7.Female who is willing to become pregnant during the period starting the day of vaccination and ending one month after vaccination.
8.History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method