Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza virus vaccine 2009-2010 formulation

• Registration Number: NCT00945438
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation.

Objectives:

* To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.

* To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• 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
• Provision of a signed informed consent
• Able to attend all scheduled visits and comply with all trial procedures
• 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
• Entitled to national social security

Exclusion Criteria

• For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
• Febrile illness (temperature ≥ 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
• Breast-feeding woman
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• 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
• 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
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination
• Planned receipt of any vaccine in the 3 weeks following the trial vaccination
• Previous vaccination against influenza in the previous 6 months
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion
• Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
• 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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Influenza virus vaccine 2009-2010 formulation	Participants aged 18 to 59 years at enrollment.
Group 2	Influenza virus vaccine 2009-2010 formulation	Participants aged 60 years or older at enrollment.

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.	21 days post-vaccination
To provide information concerning the safety of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.	21 days post-vaccination and entire study duration