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

Sanofi Pasteur, a Sanofi Company0 sites131 target enrollmentMay 2009

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 131
Primary Endpoint: To provide information concerning the immunogenicity of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.
Status: Completed
Last Updated: 12 years ago

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

July 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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