Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

• Conditions: Vaccination of healthy subjects aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion with one dose of the new formulation of the influenza vaccine for the 2008-2009 Northern Hemisphere season

• Registration Number: EUCTR2008-000943-33-GB
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or older (from the day of the 61st 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 21 days after vaccination

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

1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
2) Febrile illness (temperature =37.5°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 egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 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 contraindicating intramuscular vaccination
15) Known Human Immunodeficiency Virus (HIV), Hepatitis B surface 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified