Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

Study Overview
=================
Brief Summary
-----------------
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).

Official Title
-----------------
Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: FluarixTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female > 6 months of age at the time of the first vaccination. Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study. If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination. Exclusion Criteria: Clinical signs of acute febrile illness at the time of entry into the study. Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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: Unprimed, > 6 to < 72 Months<br>Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed). | Biological: FluarixTM<br>* All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).<br>|
| Experimental: Unprimed, ≥ 72 to < 108 Months<br>Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed). | Biological: FluarixTM<br>* All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).<br>|
| Experimental: Primed, > 6 to < 72 Months<br>Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). | Biological: FluarixTM<br>* All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).<br>|
| Experimental: Primed, ≥ 72 to < 108 Months<br>Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). | Biological: FluarixTM<br>* All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).<br>|
| Experimental: Primed, ≥ 108 to < 216 Months<br>Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). | Biological: FluarixTM<br>* All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).<br>|
| Experimental: Primed, ≥ 216 Months<br>Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). | Biological: FluarixTM<br>* All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Severe Unsolicited Adverse Events | An Adverse Event 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. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities | During the 21-day follow-up period (Day 0 to Day 20) after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis. | During the 4-day follow up (Day 0 to 3) after vaccination. | 
| Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis. | During the 4-day follow up (Day 0 to 3) after vaccination. | 
| Number of Participant Reporting Unsolicited Adverse Events. | An Adverse Event 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 follow-up period (Day 0 to Day 20) after vaccination | 
| Number of Participants 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. | Within 1 month following vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Korea, FluarixTM