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Status:

COMPLETED

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Lead Sponsor:

Sanofi Pasteur, a Sanofi Company

Conditions:

Influenza

Swine-origin A/H1N1 Influenza

Eligibility:

All Genders

6-9 years

Phase:

PHASE2

Brief 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 vacci...

Detailed Description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2010

    Estimated Enrollment :

    474 Patients enrolled

    Trial Details

    Trial ID

    NCT00952419

    Start Date

    August 1 2009

    End Date

    June 1 2010

    Last Update

    April 14 2016

    Active Locations (20)

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    Page 1 of 5 (20 locations)

    1

    Miami Beach, Florida, United States, 33141

    2

    Marietta, Georgia, United States, 30062

    3

    Woodstock, Georgia, United States, 30189

    4

    Crestview Hills, Kentucky, United States, 41017