Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

Study Overview
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Brief Summary
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Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination

Official Title
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A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years

Conditions
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Prophylaxis of Avian Influenza

Intervention / Treatment
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* Biological: H5N1 Influenza Vaccine
* Biological: H5N1 Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Exclusion Criteria: Receipt of Seasonal Influenza Vaccine for season 2007/2008 Receipt of another vaccine within 3 weeks before and after each vaccination Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant Children who are in the local recommendation for influenza vaccination due to underlying diseases

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>0.5mL of H5N1 vaccine 7.5ug | Biological: H5N1 Influenza Vaccine<br>* Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).<br>|
| Active Comparator: Arm 2<br>0.25 or 0.5mL of H5N1 vaccine | Biological: H5N1 Influenza Vaccine<br>* Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart |  | administered 3 weeks apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1 |  | 12 months after primary immunization | 
| safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies |  | 12 months after primary immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bird flu, seasonal influenza vaccine, influenza vaccine, prepandemic vaccine, virus strain with the potential to cause pandemic, toddlers, children, adolescents