Immunogenicity Study of the Influenza Vaccine in Adults
Orthomyxoviridae Infections, Influenza

About this trial
This is an interventional prevention trial for Orthomyxoviridae Infections focused on measuring Influenza, Orthomyxoviruses, Inactivated, Split-virion influenza vaccine, adults, Myxovirus Infection, Orthomyxovirus Infection
Eligibility Criteria
Inclusion Criteria: Aged 18 to 57 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 V01 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 four weeks after, the first vaccination. At Year 1 (Visit 05): -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05 At Year 2 (Visit 07): -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07 Exclusion Criteria: Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components; in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. Febrile illness (rectal equivalent temperature >= 38.0°C) on the day of inclusion Breast-feeding Participation in another clinical trial in the four weeks preceding the first 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 corticosteroid therapy. 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 first trial vaccination Vaccination planned in the four weeks following the first trial vaccination Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine Thrombocytopenia or bleeding disorder contraindicating IM vaccination Subject deprived of freedom by an administrative or court order; or in an emergency setting; or hospitalized without his/her consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2