Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

Study Overview
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Brief Summary
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Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.

Official Title
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A Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1when Administered to Adult and Elderly Subjects With and Without Immunosuppressive Conditions

Conditions
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Influenza, Human, Flu, Human, Flu, Avian, Influenza, Influenza A Virus, H5N1 Subtype

Intervention / Treatment
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* Biological: Novartis Investigational H5N1 vaccine
* Biological: Novartis Investigational H5N1 vaccine
* Biological: Novartis Seasonal Influenza Vaccine
* Biological: Novartis Seasonal Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; Individuals who are able to comply with all study procedures and requirements; Healthy volunteers and volunteers specifically HIV positive, transplant recipients, cancer patients may be eligible; Please contact the site for additional eligibility criteria. Exclusion Criteria: Individuals who are not able to follow all the required study procedures for the whole period of the study; Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study; Please contact the site for additional eligibility criteria.

Ages Eligible for Study
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Minimum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: aH5N1 adult<br>aH5N1 healthy and non-healthy adults | Biological: Novartis Investigational H5N1 vaccine<br>* 2 doses of 0.5 ml, 3 weeks apart<br>|
| Experimental: Arm 2: aH5N1 elderly<br>aH5N1 healthy and non-healthy elderly | Biological: Novartis Investigational H5N1 vaccine<br>* 2 doses of 0.5 ml, 3 weeks apart<br>|
| Active Comparator: Arm 4: aTIV elderly<br>aTIV healthy and non-healthy elderly | Biological: Novartis Seasonal Influenza Vaccine<br>* 2 doses of 0.5 ml, 3 weeks apart<br>|
| Active Comparator: Arm 3: aTIV adult<br>aTIV healthy and non-healthy adults | Biological: Novartis Seasonal Influenza Vaccine<br>* 2 doses of 0.5 ml, 3 weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving seroconversion* | *seroconversion: (defined as HI ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10]) on day 43. | day 43 | 
| Geometric mean ratios (GMRs) as determined by HI assay |  | day 43 | 
| Percentage of subjects with an HI titer ≥1:40 |  | day 43 | 
| Solicited and unsolicited adverse events | In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine. | day 202 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titers as determined by Hemagglutination Inhibition |  | Day 1 | 
| Geometric mean titers as determined by Hemagglutination Inhibition |  | Day 22 | 
| Geometric mean titers as determined by Hemagglutination Inhibition |  | Day 43 | 
| Geometric mean titers as determined by Single Radial Hemolysis |  | Day 1 | 
| Geometric mean titers as determined by Single Radial Hemolysis |  | Day 22 | 
| Geometric mean titers as determined by Single Radial Hemolysis |  | Day 43 | 
| Geometric Mean Ratio as determined by Hemagglutination Inhibition |  | Day 22 | 
| Geometric Mean Ratio as determined by Hemagglutination Inhibition |  | Day 43 | 
| Geometric Mean Ratio as determined by Single Radial Hemolysis |  | Day 22 | 
| Geometric Mean Ratio as determined by Single Radial Hemolysis |  | Day 43 | 
| Percentage of subjects achieving seroconversion determined by HI | seroconversion is defined as HI ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10]) on days 22 | Day 22 | 
| Percentage of subjects achieving seroconversion determined by SRH | seroconversion (defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) on days 22, 43 | Day 22 | 
| Percentage of subjects achieving seroconversion determined by SRH | seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) on days 22, 43 | Day 43 | 
| Percentage of subjects with an HI titer ≥1:40 |  | Day 1 | 
| Percentage of subjects with an HI titer ≥1:40 |  | Day 22 | 
| Percentage of subjects with geometric mean area ≥25 mm2 |  | Day 1 | 
| Percentage of subjects with geometric mean area ≥25 mm2 |  | Day 22 | 
| Percentage of subjects with geometric mean area ≥25 mm2 |  | Day 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza,, H5N1, aH5N1, H5N1 vaccine, Pandemic Influenza vaccine, MF59, Adjuvant, Avian flu, Underlying Immunosuppressive, immunosuppressive conditions, Pandemic vaccine, Adjuvanted vaccine