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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Fluarix Elderly Group	Fluarix™/Influsplit SSW®	Subjects who are \> 60 years of age received one dose of Fluarix™
Fluarix Adult Group	Fluarix™/Influsplit SSW®	Subjects who are 18-60 years of age received one dose of Fluarix™

Primary Outcome Measures

Name	Time	Method
Number of Seroconverted Subjects	Day 21	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
Seroconversion Factor	Day 21	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
Seroprotection Power	Day 21	Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40
Hemagglutination Inhibition (HI) Antibody Titer	Day 0 and Day 21	Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Number of Subjects With HI Antibody Titer Above the Cut-off Value	Day 0 and Day 21	The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Number of Seroprotected Subjects	Day 0 and Day 21	A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Solicited Local Symptoms	During the 4-day (Day 0-3) post-vaccination period	Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
Number of Subjects Reporting Solicited General Symptoms	During the 4-day (Day 0-3) post-vaccination period	Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
Number of Subjects Reporting Unsolicited Adverse Events (AE)	During the 21-day (Day 0-20) post-vaccination period	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.
Number of Subjects Reporting Serious Adverse Events (SAE)	During the entire study period	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.