Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children

Study Overview
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Brief Summary
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This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. Study objectives: To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule. To describe the immune response after each vaccination in subjects receiving study vaccine.

Detailed Description
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Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.

Official Title
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Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children

Conditions
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Influenza, Orthomyxoviridae Infections, Orthomyxovirus Infections

Intervention / Treatment
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* Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : All Subjects Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures. Completion of vaccination according to the national immunization schedule Subjects Aged ≥ 2 Years to < 18 Years: Aged ≥ 2 years to < 18 years on the day of inclusion. Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects ≥ 12 years. For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination. Subjects Aged ≥ 6 Months to < 2 Years: Aged ≥ 6 months to < 2 years on the day of inclusion. Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations). Exclusion Criteria : All subjects Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination Planned participation in another clinical trial during the present trial period 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 corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response Receipt of any vaccine in the 4 weeks preceding trial vaccination Planned receipt of any vaccine in the 4 weeks following any trial vaccination (Known) Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity Previous vaccination against avian influenza with either the trial vaccine or another vaccine Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw Subjects Aged ≥2 Years to <18 Years: For a female of child-bearing potential, known pregnancy or positive urine pregnancy test Breast-feeding female Febrile illness (temperature ≥ 37.5 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment Subjects Aged ≥ 6 Months to < 2 Years: History of seizures Febrile illness (temperature ≥ 38 °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: 17 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants on vaccination schedule 1 (Day 0 and Day 21) | Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Group 2<br>Participants on vaccination schedule 2 (Day 0 and Day 14) | Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Group 3<br>Participants on vaccination schedule 3 (Day 0 and Day 42) | Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine<br>* 0.5 mL, Intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. |  | 21 days post-vaccination and entire study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. |  | 21 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Orthomyxoviruses, Split Virion Pandemic Influenza Vaccine, A/H5N1