A Study of a Seasonal Trivalent Split, Inactivated Influenza Vaccine
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Influenza vaccine, split inactivated; Placebo
Intervention description: Seasonal trivalent inactivated influenza vaccine (TIV), inactivated split virion, purified by sucrose gradient ultracentrifugation. The vaccine is produced in hen's eggs, and inactivated with beta-propiolactone.; 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: Grippe; Human Flu; Human influenza

Summary:

      This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of
      participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;
      A/H3N2 and B) 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:

          -  Healthy 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 Memory Aids 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) from Day 0 through the Day 21 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 21 visit.

          -  Current or recent (within 2 weeks of vaccination) 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 21 visit.

          -  Chronic administration (defined as more than 14 consecutively-prescribed days) of
             immunosuppressants or other immune-modulating therapy within six months prior to study
             vaccination. (For corticosteroids, this means prednisone or equivalent, equal or more
             than 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.

          -  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 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.