A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Official Title
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A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years

Conditions
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Influenza

Intervention / Treatment
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* Biological: CSL Limited Influenza Virus Vaccine (Afluria®)
* Biological: US Licensed Influenza Virus Vaccine (Fluzone®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ; Written informed consent ; Willingness to provide a blood sample. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines; Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine; Known history of Guillain-Barré Syndrome; Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C). Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders; History of seizures; Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder; Clinically significant history of malignancy Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine; Current immunosuppressive or immunomodulative therapy; Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine; Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ; Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine. Current treatment with warfarin or other anticoagulants; Major congenital defects; Evidence, or history (within the previous 12 months) of drug or alcohol abuse; Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards; History of psychiatric disorders; Resident of long term care facility.

Ages Eligible for Study
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Minimum Age: 65 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: Afluria®<br> | Biological: CSL Limited Influenza Virus Vaccine (Afluria®)<br>* A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.<br>|
| Active Comparator: Fluzone®<br> | Biological: US Licensed Influenza Virus Vaccine (Fluzone®)<br>* A single 0.5 mL, intramuscular injection in 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 |
| --- | --- | --- |
| Geometric Mean Titer 21 Days After the Study Vaccination |  | 21 days after vaccination | 
| Percentage of Participants With Seroconversion 21 Days After the Study Vaccination | Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination. | 21 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Intensity of Local and Systemic Solicited Symptoms |  | 5 days after vaccination | 
| Duration of Local and Systemic Solicited Symptoms |  | 5 days after vaccination | 
| Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Abbreviation UAE stands for Unsolicited Adverse Event. | 21 days after vaccination | 
| Serious Adverse Events |  | 180 days after vaccination | 
| New Onsets of Chronic Illness | A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension). | 180 days after vaccination |