Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

Study Overview
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Brief Summary
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The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults

Official Title
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A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults

Conditions
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Influenza

Intervention / Treatment
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* Biological: MF59 adjuvanted H5N1 influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female volunteers 18-60 years of age Exclusion Criteria: Any auto-immune disease or other serious acute, chronic or progressive disease Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms<br> | Biological: MF59 adjuvanted H5N1 influenza vaccine<br>* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 non-adjuvanted influenza vaccine containing 15 ug of H5N1<br>|
| Experimental: MF59 adjuvant H5N1 influenza vaccine 15 micrograms<br> | Biological: MF59 adjuvanted H5N1 influenza vaccine<br>* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 non-adjuvanted influenza vaccine containing 15 ug of H5N1<br>|
| Experimental: non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen<br> | Biological: MF59 adjuvanted H5N1 influenza vaccine<br>* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 non-adjuvanted influenza vaccine containing 15 ug of H5N1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination. |  | day 1 to day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study. |  | Day 1 to Day 382 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen, MF59, Pandemic influenza disease