Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Intervention description: Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 micrograms per dose. Both doses of the vaccine will be administered as a single 0.5 mL injection in the deltoid muscle of the preferred arm or into the anterolateral thigh muscle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 583.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1, influenza A viruses, vaccine, infants, children

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. Up to 650 healthy
      volunteers from three age groups (greater than or equal to 6 months to less than 36 months,
      greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of
      influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate.
      Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups.
      Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants
      will receive vaccine injections on Days 0 and 21 in the arm or thigh 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 aged 6 months to 17 years, inclusive.

          -  Subjects of child-bearing potential must agree to practice adequate contraception that
             may include, but is not limited to, abstinence, 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.

          -  The subject must be in good health as determined by axillary (<10 years of age) or
             oral temperature (axillary temperature <100 degrees Fahrenheit or oral temperature
             <101 degrees Fahrenheit), medical history, and targeted physical examination based on
             medical history.

          -  Subject and/or parent(s)/legal guardian(s) must be willing and able to comply with
             planned study procedures and be available for all study visits.

          -  Subject and/or parent(s) legal guardian(s) must provide written informed consent prior
             to initiation of any study procedures, and subject may provide written assent as
             appropriate.

        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 or
             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 including major depression.

          -  Have been hospitalized for psychiatric illness, history of suicide attempt, or
             confinement for danger to self or others.

          -  Are receiving any 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) or any drugs for treatment of
             depression.

          -  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 routine
             childhood immunizations provided outside the scope of this study, and seasonal
             influenza vaccines. The initiation of this protocol does not take precedence over
             routine immunizations.

          -  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 axillary temperature greater than 100 degrees
             Fahrenheit or an oral temperature greater than or equal to 101 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.

          -  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.