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

Influenza, Human Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663102
• Other study ID #: 204687
• Status: Completed
• Start date: October 20, 2016
• Est. completion date: February 5, 2021

Study information

• Verified date: October 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1388
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Daegu-si
Korea, Republic of	GSK Investigational Site	Donghae
Korea, Republic of	GSK Investigational Site	Gwangmyeong
Korea, Republic of	GSK Investigational Site	Gyeongsangbuk-do
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon-si, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Ulsan
Korea, Republic of	GSK Investigational Site	Yangju-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Primary	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.	During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Primary	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.	During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)