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

GlaxoSmithKline1,388 enrolled

Overview

The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.

Adults and previously vaccinated children aged ≥6 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 6 months to less than (\<) 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.

Study Type

OBSERVATIONAL

Enrollment

1,388

Conditions

Influenza, Human

Interventions

Data collectionOTHER

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.

Eligibility

Sex: ALLMin age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (21)

GSK Investigational Site

Busan, South Korea

GSK Investigational Site

Daegu, South Korea

Outcomes

Primary Outcomes

Number of Participants With Expected Adverse Events (AEs)

An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.

Time frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Number of Participants With Unexpected Adverse Events (AEs)

Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.

Time frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Number of Participants With Serious Adverse Events (SAEs)

SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.

Time frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Data from ClinicalTrials.gov

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