Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

Study Overview
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Brief Summary
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This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.

Official Title
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Immunogenicity and Safety Study of a Single Injection of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2008 - 2009 Season) in Adults Aged 18 to 60 Years and Over 60 Years.

Conditions
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Influenza Vaccines

Intervention / Treatment
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* Biological: Fluviral®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol. Male and female adults, 18 to 60 years of age and over 60 years of age. Written informed consent obtained from the subject. Satisfactory baseline medical assessment by history and physical examination. Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits. Exclusion Criteria: Acute disease at the time of enrollment. Significant acute or chronic, uncontrolled medical or psychiatric illness. Any confirmed or suspected immunosuppressive condition including: History of human immunodeficiency virus (HIV) infection, Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. History of renal impairment. History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol. Complicated insulin-dependent diabetes mellitus. Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment. Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder. Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed. A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome. Presence of an active neurological disorder. History of chronic alcohol consumption and/or drug abuse. Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible. Receipt of an influenza vaccine within 6 months prior to study enrollment. Administration of any vaccines within 30 days prior to study enrollment or during the study period. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. Any known or suspected allergy to any constituent of the vaccine. A history of severe adverse reaction to a previous influenza vaccination. If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study. Lactating/nursing female. Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

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: Fluviral Adult Group<br>Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine. | Biological: Fluviral®<br>* One intramuscular injection into the deltoid region of the non-dominant arm<br>|
| Experimental: Fluviral Elderly Group<br>Subjects aged more than 60 years received a single dose of Fluviral® vaccine. | Biological: Fluviral®<br>* One intramuscular injection into the deltoid region of the non-dominant arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination Inhibition (HI) Antibody Titers | Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains. | At Day 0 and 21 | 
| Number of Seroconverted Subjects | Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains. | At Day 21 | 
| Number of Seroprotected Subjects | Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains. | At Day 0 and 21 | 
| Fold Increase From Baseline in Serum HI Antibody Titer | The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains. | At Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever. | During the 4-day (Day 0-3) post-vaccination period | 
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | During the 21-day (Day 0-20) post-vaccination period | 
| Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | During the 21-day (Day 0-20) post-vaccination period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluviral, Influenza