Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3200

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 18 years or over on the day of inclusion
2) Informed Consent Form has been signed and dated
3) Able to attend all scheduled visits and to comply with all trial procedures
4) For a woman, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination, or having undergone a surgical sterilization or being post-menopausal
5) Covered by health insurance or entitled to national social security depending on local regulations
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

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Known pregnancy, or a positive urine pregnancy test
2) Currently breastfeeding a child
3) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
6) Planned receipt of any vaccine prior to the blood sample performed 21 days after the second trial vaccination
7) Previous vaccination with an H5N1 vaccine
8) History of H5N1 infection or exposure to presumed/confirmed (either clinically, serologically, or microbiologically) cases of H5N1-infected humans or animals
9) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
10) Known or suspected 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
11) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
12) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
13) Self-reported thrombocytopenia, contraindicating IM vaccination
14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the opinion of the investigator
15) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
16) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
18) Identified as 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 (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
19) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
20) Receipt of any vaccine with an adjuvant (except for aluminum) in a context of a clinical trial in the past 2 years
21) Receipt of an A/H1N1 pandemic influenza vaccine in the context of the national pandemic vaccination campaign 2009-2010
22) Known or suspected autoimmune disease or systemic disease (e.g. Sjögren syndrome, lupus erythematosus, rhumatoïde arthritis, sarcoïdosis, vasculitis, etc…)

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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