Safety and immunogenicity of an intramuscular, inactivated, split-virion, pandemic influenza A/H5N1 vaccine in adults and the elderly.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

1) Aged over 18 years on the day of inclusion, and 18 to 60 years for the 50 additional subjects for A/Indonesia primary series.
2) Informed consent form signed.
3) Able to attend all scheduled visits and to comply with all trial procedures.
4) For a woman, inability to bear a child or negative urine pregnancy test.
5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.
6) Addendum 1 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04 for subjects who are to receive a booster at M6 or later).
7) Addendum 2 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04_Add for subjects who are to receive a A/Indonesia booster.
8) Addendum 3 of the Informed Consent Form signed and dated by the subject (this inclusion criterion has to be checked only at V05 for subjects who are to receive a A/Indonesia booster).
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) 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).
2) Febrile illness (oral temperature =37.5°C) on the day of inclusion.
3) Breast-feeding.
4) Previous vaccination with an avian flu vaccine.
5) Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
6) Planned participation in another clinical trial during the present trial period.
7) 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.
8) Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
9) Current alcohol or drug abuse that may interfere with the subject’s ability to comply with trial procedures.
10) Receipt of blood or blood-derived products within the past 3 months.
11) Any vaccination within 4 weeks prior to the first trial vaccination.
12) Vaccination planned within 4 weeks after any trial vaccination.
13) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
14) 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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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