Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.

Study Overview
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Brief Summary
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The purpose of this study is collect safety information on the use of Fluarix Tetra according to the approved PI, over a period of 6 years from children (over 3 years of age) and adults in Korea.

Detailed Description
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Adults and previously vaccinated children aged ≥36 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 36 months to <9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local PI in Korea. Fluarix Tetra may be administered to pregnant women/lactating women as per PI, if there is a clear need. Pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.

Official Title
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Assessment of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information in Korea.

Conditions
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Influenza, Human

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI. Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject's parent(s)/Legally acceptable Representative(s) [LAR(s)]. Exclusion Criteria: Those who are not eligible for vaccination with Fluarix Tetra according to the local PI. Hypersensitivity reaction to Fluarix Tetra. History of hypersensitivity reaction to Influenza vaccine. History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination. Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.

Ages Eligible for Study
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Minimum Age: 36 Months

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluarix Tetra Group<br>Subjects aged 3 years and above who will receive Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation). | Other: Data collection<br>* Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of expected and unexpected adverse events (AEs) |  | During the 21 days (Day 0 to Day 20) follow-up period after vaccination | 
| Occurrence of serious adverse events (SAEs) |  | From the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Post-marketing, Korea, Drug utilization study, Fluarix Tetra