H5N1 Vaccine Study in Japanese Adults

Study Overview
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Brief Summary
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The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.

Official Title
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A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Japanese Adult Population Aged 18 to 59 Years

Conditions
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H5N1 Influenza

Intervention / Treatment
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* Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 to 59 years old at the time of screening Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary If female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study Exclusion Criteria: Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers) Subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder Subject has any inherited or acquired immunodeficiency Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs Subject has a history of severe allergic reactions or anaphylaxis Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry Subject has donated blood or plasma within 30 days prior to study entry Subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study Subject has a functional or surgical asplenia Subject has a known or suspected problem with alcohol or drug abuse Subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study If female, subject is pregnant or lactating at the time of enrollment Subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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: Treatment group I / Intramuscular<br>85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22 | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)<br>* Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm<br>|
| Experimental: Treatment group II / Intramuscular<br>85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22 | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)<br>* Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm<br>|
| Experimental: Treatment group III / Subcutaneous<br>85 subjects to receive 2 subcutaneous vaccinations at Dose A on Days 1 and 22 | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)<br>* Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm<br>|
| Experimental: Treatment group IV / Subcutaneous<br>85 subjects to receive 2 subcutaneous vaccinations at Dose B on Days 1 and 22 | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)<br>* Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with antibody response to the vaccine strain | Measurement by single radial hemolysis (SRH) assay | 21 days after 2nd vaccination | 
| Number of subjects demonstrating seroconversion | Measurement by SRH assay | 21 days after 2nd vaccination | 
| Fold increase of antibody response | Measurement by SRH assay | 21 days after 2nd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with antibody response to the vaccine strain | Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay | 21 days after 1st and 21+180 days after 2nd vaccination | 
| Number of subjects demonstrating seroconversion | Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay | 21 days after 1st and 21+180 days after 2nd vaccination | 
| Antibody response | Measurement by SRH, MN and HI assay | 21 days after 1st and 21 + 180 days after 2nd vaccination | 
| Fold increase of antibody response | Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay | 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)