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

October 16, 2023 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 47545
        • GSK Investigational Site
      • Daegu, Korea, Republic of, 42274
        • GSK Investigational Site
      • Daegu, Korea, Republic of, 700 712
        • GSK Investigational Site
      • Daegu-si, Korea, Republic of, 42601
        • GSK Investigational Site
      • Donghae, Korea, Republic of, 25768
        • GSK Investigational Site
      • Gwangmyeong, Korea, Republic of, 484 5
        • GSK Investigational Site
      • Gyeongsangbuk-do, Korea, Republic of, 39230
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 22214
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03966
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 04143
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 04168
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 138201
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03722
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 03181
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 06568
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 08737
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 7499
        • GSK Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16388
        • GSK Investigational Site
      • Ulsan, Korea, Republic of, 683380
        • GSK Investigational Site
      • Yangju-si, Gyeonggi-do, Korea, Republic of, 11456
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects aged 6 months and above who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra in Korea according to the locally approved PI.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fluarix Tetra Group 1
Subjects aged between 6-35 months old who received 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.
Fluarix Tetra Group 2
Subjects aged 3 years and above who received 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Expected Adverse Events (AEs)
Time Frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
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)
Number of Participants With Unexpected Adverse Events (AEs)
Time Frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
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)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2016

Primary Completion (Actual)

February 5, 2021

Study Completion (Actual)

February 5, 2021

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimated)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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