Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

Study Overview
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Brief Summary
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This is an open, randomized, multicenter clinical trial. Objectives: To describe the safety profiles during the 21 days following each primary and booster injection. To describe the immune response 21 days after each primary and booster injection of each formulation. To describe the antibody persistence after the first vaccination

Conditions
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Influenza, Orthomyxoviridae Infections, Influenza A Virus Infection

Intervention / Treatment
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* Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine
* Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
* 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: Able to attend all scheduled visits and to comply with all trial procedures. Children/Adolescents aged ≥ 2 years to < 18 years: Aged ≥ 2 years to < 18 years on the day of inclusion. Informed Consent Form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate. For a female, inability to bear a child or negative urine pregnancy test (as applicable). For a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable). Infants/toddlers 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 kg. Informed Consent Form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate. Subject who completed vaccination according to the national immunization schedule. Exclusion Criteria : All subjects: Participation in another clinical trial in the 4 weeks preceding the first trial vaccination. Planned participation in another clinical trial during the present trial period. 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. Systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9). Chronic illness at a stage that could interfere with trial conduct or completion. Blood or blood-derived products received in the past 3 months. Any vaccination in the 4 weeks preceding the first trial vaccination. Vaccination planned in the 4 weeks following any trial vaccination. History of the H5N1 infection (confirmed either clinically, serologically or virologically). Known HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity. Previous vaccination with an avian flu vaccine. Subject at high risk of the H5N1 infection during the trial. Thrombocytopenia or bleeding disorder contraindicating IM vaccination. Febrile illness (rectal equivalent temperature ≥ 38.0°C) on the day of inclusion. Children/Adolescents aged ≥ 2 years to < 18 years: Breast-feeding mothers. Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures (if applicable, depending on the subject's age). Infants/toddlers aged ≥ 6 months to < 2 years: History of seizures.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 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: Study Group 1<br>Subjects aged 9 to 17 years | Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Study Group 2<br>Subjects aged 3 to 8 years | Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine<br>* 0.5 mL, Intramuscular<br>|
| Experimental: Study Group 3<br>Subjects aged 6 to 35 months | Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine<br>* 0.25 mL, Intramuscular<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe safety following administration of A/H5N1 inactivated 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 A/H5N1 Virus, Influenza Pandemic, Orthomyxoviridae Infections