Sanofi H1N1 + TIV - Adults and Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent inactivated influenza vaccine; Inactivated H1N1 Vaccine; Placebo
Intervention description: Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.; Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle.; Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 805.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1, influenza A viruses, vaccine, elderly, TIV

Summary:

      The purpose of this study is to assess the safety and immune response (body's defense against
      disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study
      will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make
      it most effective. Participants will include up to 850 healthy adults, ages 18 and older.
      Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the
      seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical
      history, physical exam, maintaining a memory aid, and blood sample collection. Participants
      will be involved in the study for about 8 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are males or non-pregnant females age 18 and older, inclusive.

          -  Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral
             oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal
             to 1 year) must agree to practice adequate contraception that may include, but is not
             limited to, abstinence, monogamous relationship with vasectomized partner, barrier
             methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed
             hormonal methods during the study for at least 30 days following the last vaccination.

          -  Are in good health, as determined by vital signs, medical history to ensure any
             existing medical diagnoses or conditions are stable and not considered clinically
             significant, and targeted physical examination based on medical history. A stable
             chronic medical condition is defined as no change in prescription medication, dose, or
             frequency of medication in the last 3 months and health outcomes of the specific
             disease are considered to be within acceptable limits in the last 6 months. Any change
             that is due to change of health care provider, insurance company etc, or that is done
             for financial reasons, as long as in the same class of medication will not be
             considered a violation of this inclusion criterion. Any change in prescription
             medication due to improvement of a disease outcome will not be considered a violation
             of this inclusion criterion.

          -  Are able to understand and comply with planned study procedures.

          -  Provide written informed consent prior to initiation of any study procedures.

        Exclusion Criteria:

          -  Have a known allergy to eggs or other components of the vaccine (including gelatin,
             formaldehyde, octoxinol, thimerosal and chicken protein).

          -  Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if
             female of childbearing potential), or women who are breastfeeding.

          -  Have immunosuppression as a result of an underlying illness or treatment, or use of
             anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36
             months.

          -  Have an active neoplastic disease or a history of any hematologic malignancy.

          -  Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled
             steroids (>800 micrograms (mcg)/day of beclomethasone dipropionate or equivalent)
             within the preceding 6 months. (Nasal and topical steroids are allowed.)

          -  Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric
             diagnosis.

          -  Have been hospitalized for psychiatric illness, history of suicide attempt, or
             confinement for danger to self or others, within the past 10 years.

          -  Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol,
             molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone,
             mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine,
             perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium
             carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug
             and are stable for at least 3 months prior to enrollment, without de-compensating
             symptoms will be allowed to be enrolled in the study.

          -  Have a history of receiving immunoglobulin or other blood product within the 3 months
             prior to vaccination in this study.

          -  Received an experimental agent (vaccine, drug, biologic, device, blood product, or
             medication) within 1 month prior to vaccination in this study or expect to receive an
             experimental agent during the study period (prior to Day 180 after the third
             vaccination).

          -  Have received any live licensed vaccines within 4 weeks or inactivated licensed
             vaccines within 2 weeks prior to vaccination in this study or plan receipt of such
             vaccines within 21 days following the last vaccination.

          -  Has received a licensed 2009-2010 seasonal influenza vaccine.

          -  Have an acute or chronic medical condition that, in the opinion of the investigator,
             would render vaccination unsafe, or would interfere with the evaluation of responses.

          -  Have a history of severe reactions following previous immunization with influenza
             virus vaccines.

          -  Have an acute illness, including an oral temperature greater than 100.4 degrees
             Fahrenheit, within 3 days prior to vaccination.

          -  Have any condition that would, in the opinion of the site investigator, place them at
             an unacceptable risk of injury or render them unable to meet the requirements of the
             protocol.

          -  Participated in a novel influenza H1N1 2009 vaccine study in the past two years or
             have a history of novel influenza H1N1 2009 infection prior to enrollment.

          -  Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
             infection.

          -  Have a history of alcohol or drug abuse in the last 5 years.

          -  Plan to travel outside of North America in the time between the first vaccination and
             63 days following the first vaccination.

          -  Have a history of Guillain-Barré Syndrome.

          -  Have any condition that the investigator believes may interfere with successful
             completion of the study.