A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

Sanofi

Status and phase

Completed

Phase 2

Conditions

Influenza

Orthomyxoviridae Infections

Treatments

Biological: Inactivated influenza vaccine (split virion)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00343681

GRT63

Details and patient eligibility

About

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged at least 18 years on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures
For a woman, inability to bear a child or negative urine pregnancy test at Visit 1
For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.

Exclusion criteria

Febrile illness (oral temperature >=37.5°C) on the day of vaccination
Breast-feeding
Participation in another clinical trial in the four weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy
Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
Chronic illness at a stage that could interfere with trial conduct or completion
Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
Blood or blood-derived products received in the past three months
Any vaccination in the four weeks preceding the trial vaccination
Vaccination planned in the three weeks following the trial vaccination
Vaccination against influenza in the previous six months
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent