NCT02663102

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,388 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
OTHER	Data collection	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.

Timeline

• Start date: 2016-10-20
• Primary completion: 2021-02-05
• Completion: 2021-02-05
• First posted: 2016-01-26
• Last updated: 2024-04-05
• Results posted: 2024-04-05

Locations

21 sites across 1 country: South Korea