Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
Launched by GLAXOSMITHKLINE · Jan 21, 2016
Trial Information
Current as of June 18, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility criteria
- 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.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Donghae, , Korea, Republic Of
Gwangmyeong, , Korea, Republic Of
Incheon, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Busan, , Korea, Republic Of
Daegu Si, , Korea, Republic Of
Daegu, , Korea, Republic Of
Gyeongsangbuk Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon Si, Gyeonggi Do, , Korea, Republic Of
Yangju Si, Gyeonggi Do, , Korea, Republic Of
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials