A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.

Official Title
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A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2010/2011 Formulation of Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

Conditions
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Influenza

Intervention / Treatment
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* Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years and older at the time of the first study vaccination. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine. Clinical signs of an active infection Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry Females who are pregnant or lactating

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: CSL's 2010/2011 Formulation of Enzira® Vaccine<br>* 45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0<br>|
| Experimental: Older Adults<br>Healthy volunteers aged 60 years or older | Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine<br>* 45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0<br>|

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 |
| --- | --- | --- |
| Frequency of Any Solicited Adverse Events (AEs) | The number of participants reporting any solicited AEs. | During the 4 days after vaccination (Day 0 plus 3 days) | 
| Frequency and Intensity of Any Unsolicited Adverse Events | Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities. | After vaccination until the end of the study; approximately 21 days |