Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Trivalent Seasonal Influenza Vaccine; Placebo
Intervention description: 0.5 mL of phosphate buffered saline
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Seasonal Influenza; Trivalent Vaccine; Inactivated Vaccine

Summary:

      This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of
      subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1;
      A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and
      female adults 18 through 45 years of age will be randomized to receive vaccine (30) or
      placebo (30).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult 18 through 45 years of age at the enrollment visit.

          -  Literate (by self-report) and willing to provide written informed consent.

          -  Healthy, as established by the medical history, physical examination, and screening
             laboratory evaluations.

          -  Capable and willing to complete Diary Cards and willing to return for all follow-up
             visits.

          -  For females, willing to utilize reliable birth control measures (e.g., intrauterine
             device, hormonal contraception, condoms) through the Day 22 visit.

        Exclusion Criteria:

          -  Participation in another clinical trial involving any therapy within the previous
             three months or planned enrollment in such a trial 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.

          -  Current or recent (within 2 weeks of enrollment) acute illness with or without fever.

          -  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.

          -  Chronic administration (defined as more than 14 consecutively-prescribed days) of
             immunosuppressants or other immune-modulating therapy within six months prior to study
             enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg
             per day; topical steroids are allowed.)

          -  History of asthma.

          -  Hypersensitivity after previous administration of any vaccine.

          -  Suspected or known hypersensitivity to any of the study vaccine components, including
             chicken or egg protein, antibiotics, and rubber (from the vaccine vial stoppers).

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary,
             metabolic, neurologic, psychiatric or renal functional abnormality, as determined by
             medical history, physical examination or clinical laboratory screening tests, which in
             the opinion of the investigator, might interfere with the study objectives.

          -  History of any blood or solid organ cancer.

          -  History of thrombocytopenic purpura or known bleeding disorder.

          -  History of seizures.

          -  Known or suspected immunosuppressed or immunodeficient condition of any kind.

          -  Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

          -  Known human immunodeficiency virus (HIV) infection (self-report).

          -  Known active tuberculosis or symptoms of active tuberculosis, regardless of cause
             (self-report).

          -  History of chronic alcohol abuse and/or illegal drug use.

          -  Pregnancy or lactation. (A negative pregnancy test will be required before
             administration of study product for all women of childbearing potential.)

          -  History of Guillain-Barré Syndrome

          -  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.

        Note: Minor out-of-range laboratory values no greater than Grade 1 will not be considered
        to be exclusionary at screening.