Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3 (IVACFLUS-0203)

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Vaccine Read More

Inclusion criteria:

• Aged 18 through 60 years on the day of screening/enrollment.
• Literate (by self-report) and willing to provide written informed consent.
• Able to attend all scheduled visits and to comply with all study procedures.
• Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable under controlled or unchanged for the past 3 months. If medication is used to treat the condition, the medication dose must have been stable for at least 1 month preceding vaccination.

For female subjects:

• Not breastfeeding or pregnant (based on negative urine pregnancy test) or plan to become pregnant up to Day 22. Women who are not surgically sterile (hysterectomy or tubal ligation) or post-menopausal for more than 1 year must have negative pregnancy test and, be willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condom or diaphragm with spermicide) through the Day 22 visit.

Exclusion criteria:

• Current or recent (within 2 weeks of enrollment) acute severe illness with or without fever.
• Participation in another clinical study involving any therapy within the previous 3 months or planned enrollment in such a study during the period of this study.
• Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit.
• Received seasonal influenza vaccine in last 6 months
• Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 22 visit.
• Known or suspected congenital or acquired immunodeficiency.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within 6 months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg/kg/day; topical steroids are allowed).
• Unstable illness by history or physical examination that in the opinion of the Investigator, might interfere with the conduct or results of the study or pose additional risk to the subject.
• Hypersensitivity after previous administration of any vaccine.
• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein, and rubber (from the vaccine vial stoppers).
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion.
• Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report).
• Current alcohol or drug addiction that in the opinion of the Investigator, might interfere with the ability to comply with study procedures.
• History of Guillain-Barré Syndrome
• Neoplastic disease or any hematologic malignancy.
• Any condition that, in the opinion of the Investigator, would increase the health risk to the subject if he/she participates in the study, or would interfere with the evaluation of the study objectives.