Sanofi Pasteur, TIV + H1N1, Pediatric Population
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated H1N1 Vaccine; Trivalent Inactivated Influenza Vaccine
Intervention description: Inactivated influenza H1N1 vaccine, 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm or in the anterolateral thigh muscle (1 injection in each arm or each thigh if receiving 2 doses).; Licensed seasonal trivalent influenza vaccine (TIV) (2009-2010 season). For subjects greater than or equal to 6 - <36 months, licensed TIV will be administered as a single 0.25 mL intramuscular (IM) injection in the deltoid muscle of the arm or in the anterolateral thigh muscle. For subjects greater than or equal to 36 months - 17 years, licensed TIV will be administered as a single 0.5 mL IM injection in the deltoid muscle of the arm or in the anterolateral thigh muscle.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 531.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1, influenza A viruses, TIV, vaccine, infants, children

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 and when the H1N1 flu shot should be given with the seasonal flu shot
      to make it most effective. The 650 participants will be divided into the following age
      groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents
      10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each
      age level. Study procedures include: medical history, targeted physical exam based on
      history, 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 aged 6 months to 17 years, inclusive.

          -  All subjects 6 months to 9 years must be "primed".

          -  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 or 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 the study period (prior to Day 180 after the last
             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. This is inclusive of routine
             childhood immunizations provided outside the scope of this study. The initiation of
             this protocol does not take precedence over routine immunizations.

          -  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 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
             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.