Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated H1N1 Vaccine
Intervention description: Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1, influenza A viruses, vaccine, elderly

Summary:

      The purpose of this study is to assess the safety and the body's immune response (body's
      defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and
      elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no
      history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old,
      and the other 200 will be greater than or equal to 65 years of age. Participants will be
      randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1
      vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine
      injections on days 0 and 21 in the arm muscle. Study procedures include: medical history,
      physical exam, maintaining a memory aid, and blood sample collection. Participants will be
      involved in study related procedures for approximately 7 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 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 this study (prior to the Day 201 follow-up call - 180 days
             after the second 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 second vaccination. This is inclusive of
             seasonal influenza vaccines.

          -  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
             42 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.