A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

Study Overview
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Brief Summary
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This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

Official Title
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A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluarix™/Influsplit SSW®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. A male or female aged 18 years or above at the time of the vaccination. Written informed consent obtained from the subject. Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study. 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 2 months after completion of the vaccination series. Exclusion Criteria: Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. Administration of an influenza vaccine within 6 months preceding the study start. Administration of an influenza vaccine other than the study vaccine during the entire study Clinically or virologically confirmed influenza infection within 6 months preceding the study start History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Not stabilized or clinically serious chronic underlying disease. Lactating female. History of chronic alcohol consumption and/or drug abuse. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 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: Fluarix Adult Group<br>Subjects who are 18-60 years of age received one dose of Fluarix™ | Biological: Fluarix™/Influsplit SSW®<br>* single intramuscular dose on Day 0<br>|
| Experimental: Fluarix Elderly Group<br>Subjects who are > 60 years of age received one dose of Fluarix™ | Biological: Fluarix™/Influsplit SSW®<br>* single intramuscular dose on Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination Inhibition (HI) Antibody Titer | Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains | Day 0 and Day 21 | 
| Number of Subjects With HI Antibody Titer Above the Cut-off Value | The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains | Day 0 and Day 21 | 
| Number of Seroprotected Subjects | A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40 | Day 0 and Day 21 | 
| Number of Seroconverted Subjects | A seroconverted subject is a subject with 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 a fold increase (Day 21/Day 0) ≥ 4 | Day 21 | 
| Seroconversion Factor | Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains | Day 21 | 
| Seroprotection Power | Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40 | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. | During the 4-day (Day 0-3) post-vaccination period | 
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, 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 lifethreatening, 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 entire study period | 

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