Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

Sanofi

Status and phase

Completed

Phase 2

Conditions

Influenza

Orthomyxoviridae Infections

Treatments

Biological: A/H5N1 inactivated, split-virion influenza virus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00545701

GPA11

Details and patient eligibility

About

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.

Objectives:

To describe the immune response 21 days after each vaccination.
To describe the safety profiles following each vaccination.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 18 to 60 years on 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.
For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.

Exclusion criteria

Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
Breast-feeding.
Previous vaccination with an avian flu vaccine.
Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
Current alcohol or drug abuse 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 first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
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.