Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 720
Summary
- Conditions
- Influenza, Human
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 36 years and 125 years
- Gender
- Both males and females
Description
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. Fl...
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.
Tracking Information
- NCT #
- NCT02663102
- Collaborators
- Not Provided
- Investigators
- Study Director: GSK Clinical Trials GlaxoSmithKline
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