A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
Condition: Influenza; Swine-origin A/H1N1 Influenza
MeSH terms: Influenza, Human
Intervention: Monovalent Subvirion A/H1N1 Influenza vaccine; Monovalent Subvirion A/H1N1 Influenza vaccine; Normal saline solution (placebo)
Intervention description: 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months); 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months); 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 474.0
Sex: All
Minimum age: 6 Months
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Children

Summary:

      The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic
      vaccine in toddlers and children.

      Primary Objectives:

        -  To describe the immunogenicity of the candidate vaccines after each injection.

        -  To describe the safety of the candidate vaccines after each injection.
    

Eligibility criteria:

        Inclusion Criteria :

        All subjects:

          -  Provision of Informed Consent Form signed by the subject's parent(s)/legal
             representative (and by an independent witness if required by local regulations). In
             addition, provision of Assent Form signed by subjects aged 7 to 9 years

          -  Subject and parent/guardian are able to attend all scheduled visits and to comply with
             all trial procedures

        Subjects aged 3 to 9 years:

          -  Healthy children aged 3 to 9 years on the day of inclusion

        Subjects aged 6 to 35 months:

          -  Healthy infants and toddlers aged 6 to 35 months on the day of inclusion

          -  Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

        Exclusion Criteria :

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the first trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination

          -  Planned receipt of any vaccine prior to the Day 42 blood sample

          -  Receipt of blood or blood-derived products in the past 3 months which might interfere
             with the assessment of immune response

          -  Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
             such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
             or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2
             consecutive weeks within the past 3 months)

          -  Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B
             surface antigen, or Hepatitis C

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
             containing any of the same substances

          -  Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination

          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion
             contraindicating IM vaccination

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Chronic illness that in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Employees of the investigator or study center, with direct involvement in the proposed
             study or other studies under the direction of that investigator or study center, as
             well as family members of the employees or the investigator.

          -  Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March
             2009

          -  Personal or family history of Guillain-Barré syndrome

          -  Active neoplastic disease or a history of any hematologic malignancy

          -  Known seizure/epilepsy history and/or taking anti-seizure medication

          -  Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and
             stable for at least 3 months prior to enrollment, without decompensating symptoms will
             be allowed to enroll in the study

          -  Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute
             illness/infection (according to investigator judgment) on the day of vaccination