Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intramuscular Route) - Immunogenicity and Safety of a Vaccine against Influenza (2010-2011 NH season, intramuscular route)
- Conditions
- Vaccination of adults up to 60 years of age an elderly of 61 years of age and over with inactivated split-virion influenza vaccine administerd by intramuscular route.
- Registration Number
- EUCTR2009-017690-38-FR
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 129
An individual must fulfill all of the following criteria in order to be eligible for trial
enrollment:
1) Aged 18 years or over on the day of inclusion
2) Informed consent form has been signed and dated
3) Able to attend all scheduled visits and to comply with all trial procedures
4) For a woman of childbearing potential, use of an effective method of
contraception or abstinence from at least 4 weeks prior to vaccination until at least
4 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
An individual fulfilling any of the following criteria is to be excluded from trial
enrollment:
1) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection
(according to investigator judgment) on the day of vaccination
2) 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 vaccine used in the trial or to a vaccine
containing any of the same substances
3) Known pregnancy, or a positive urine pregnancy test
4) Currently breastfeeding a child
5) History of pandemic H1N1 influenza vaccination
6) History of clinically or laboratory confirmed pandemic H1N1 influenza infection
7) History of influenza vaccination within the previous 6 months (other than
pandemic H1N1 influenza vaccine)
8) Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous
12 months
9) Known or suspected congenital or acquired immunodeficiency, resulting for
example from:
- End-stage renal disease requiring dialysis
- Active neoplastic disease or active hematologic malignancy
- Receipt of immunosuppressive therapy or other immune-modifying drugs
such as, but not limited to: anti-cancer chemotherapy or radiation therapy
within the preceding 6 months, or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past
3 months)
10) History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B,
or Hepatitis C
11) Receipt of blood or blood-derived products in the past 3 months, which might
interfere with assessment of the immune response
12) Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion
13) History of thrombocytopenia, contraindicating IM vaccination
14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating IM vaccination
15) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
16) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
17) Participation in another clinical trial investigating a vaccine, drug, medical device,
or medical procedure in the 4 weeks preceding the trial vaccination
18) Planned participation in another clinical trial during the present trial period
19) Deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized involuntarily
20) Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures
21) Identified as 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 (i.e., immediate, husband,
wife and their children, adopted or natural) 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