Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route) - Immunogenicity and Safety of a Vaccine Against Influenza (2009-2010 Northern Hemisphere Season)
- Conditions
- Vaccination of adults up to 59 years of age and elderly of 60 years of age and over with inactivated split-virion influenza vaccine administered by the intradermal route
- Registration Number
- EUCTR2009-009977-85-FR
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 131
1) Aged 18 to 59 years (i.e. to the day before the 60th birthday) or 60 years or older (from the day of the 60th birthday) on the day of inclusion
2) Provision of a signed informed consent
3) Able to attend all scheduled visits and comply with all trial procedures
4) For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 3 weeks after vaccination
5) Entitled to national social security
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
1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
2) Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
3) Breast-feeding woman
4) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
5) Planned participation in another clinical trial during the present trial period
6) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
7) Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
9) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
10) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
11) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
12) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
13) Previous vaccination against influenza in the previous 6 months
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion
15) Known Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity
16) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
17) Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
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