Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
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|ClinicalTrials.gov Identifier: NCT02663102|
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment|
|Influenza||Other: Data collection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||720 participants|
|Official Title:||Assessment of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information in Korea.|
|Actual Study Start Date :||October 21, 2016|
|Estimated Primary Completion Date :||June 10, 2020|
|Estimated Study Completion Date :||June 10, 2020|
Fluarix Tetra Group
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
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.
- Occurrence of expected and unexpected adverse events (AEs) [ Time Frame: During the 21 days (Day 0 to Day 20) follow-up period after vaccination ]
- Occurrence of serious adverse events (SAEs) [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663102
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Korea, Republic of|
|GSK Investigational Site||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|