Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: IVACFLU; Placebo
Intervention description: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.; Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent
      A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from
      A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult 18 (age of legal consent in Vietnam) through 40 years of age at
             the enrollment visit.

          -  Literate and willing to provide written informed consent.

          -  Free of obvious health problems, as established by the medical history and screening
             evaluations, including physical examination.

          -  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 (intrauterine device,
             birth control pills, condoms) through the Day 42 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 four weeks prior to enrollment or refusal to
             postpone receipt of such vaccines until after the Day 42 visit.

          -  Current or recent (within two weeks of enrollment) acute illness with or without
             fever.

          -  Receipt of immune globulin or other blood products within three months prior to study
             enrollment or planned receipt of such products prior to the Day 42 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.

          -  Other AE following immunization, at least possibly related to previous receipt of any
             vaccine.

          -  Suspected or known hypersensitivity to any of the study vaccine components, including
             chicken or egg protein.

          -  Known hypersensitivities (allergies) to food or the natural environment.

          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, 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 leukemia or any other 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,
             including HIV infection.

          -  Known chronic HBV or HCV infection.

          -  Known active tuberculosis or symptoms of active tuberculosis, regardless of cause.

          -  History of chronic alcohol abuse and/or illegal drug use.

          -  Pregnancy or lactation. (A negative pregnancy test will be required before
             administration of study vaccine or placebo for all women of childbearing potential.)

          -  History of Guillain-Barre' 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.