A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

Official Title
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A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).

Conditions
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Influenza

Intervention / Treatment
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* Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged ≥ 18 years at the time of providing informed consent Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent Willing and able to adhere to all protocol requirements Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study Exclusion Criteria: Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry A clinically significant medical or psychiatric condition A confirmed or suspected immunosuppressive condition History of seizures History of Guillain-Barré Syndrome Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine Currently receiving treatment with warfarin or other anticoagulants Evidence or history of substance or alcohol abuse within the 12 months before study entry Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period Females who are pregnant or lactating Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults<br>Healthy volunteers aged 18 to 59 years | Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)<br>* A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.<br>* Other names: Enzira® vaccine (2009 / 2010 formulation);|
| Experimental: Older Adults<br>Healthy volunteers aged 60 years or older | Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)<br>* A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.<br>* Other names: Enzira® vaccine (2009 / 2010 formulation);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. | As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10. | Approximately 21 days after vaccination | 
| The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. | GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre. | Approximately 21 days after vaccination | 
| The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. |  | Approximately 21 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Frequency of Any Solicited Local Reactions. | The number of participants reporting any solicited local reactions. | During the 4 days after vaccination (Day 0 plus 3 days) | 
| The Frequency of Any Solicited Systemic Symptoms. | The number of participants reporting any solicited systemic symptoms. | During the 4 days after vaccination (Day 0 plus 3 days) | 
| The Incidence of Any Unsolicited Adverse Events (AEs). | The number of participants reporting any unsolicited adverse events. Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities. | After vaccination until the end of the study; approximately 21 days |