Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

Study Overview
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Brief Summary
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The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Conditions
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Influenza, Swine-origin A/H1N1 Influenza

Intervention / Treatment
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* Biological: 7.5ug H1N1 Influenza vaccine
* Biological: 15ug H1N1 vaccine
* Biological: seasonal influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures 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 first 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) 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 Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion Family members of the employees or the Investigator Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain Confirmed infection with the novel influenza A/H1N1 strain Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7.5ug H1N1 vaccine<br>360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21. | Biological: 7.5ug H1N1 Influenza vaccine<br>* 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21<br>|
| Experimental: 15ug H1N1 vaccine<br>360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21. | Biological: 15ug H1N1 vaccine<br>* 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21<br>|
| Placebo Comparator: seasonal influenza vaccine<br>180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21. | Biological: seasonal influenza vaccine<br>* 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |