Influenza, HumanNCT02663102
Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
An observational study of Influenza, Human, run by GlaxoSmithKline at 21 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Data collection
- How many people
- 1,388 participants
- Where
- 21 sitesSouth Korea
- Study dates
- 20 Oct 2016to 5 Feb 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)].
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
South Korea21 sites
GSK Investigational Site
Busan, 47545
GSK Investigational Site
Daegu, 42274
GSK Investigational Site
Daegu, 42601
GSK Investigational Site
Daegu, 700 712
GSK Investigational Site
Donghae, 25768
GSK Investigational Site
Gwangmyeong, 484 5
GSK Investigational Site
Gyeongsangbuk-do, 39230
GSK Investigational Site
Incheon, 22214
GSK Investigational Site
Seoul, 03181
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 03966
GSK Investigational Site
Seoul, 04143
GSK Investigational Site
Seoul, 04168
GSK Investigational Site
Seoul, 06568
GSK Investigational Site
Seoul, 08737
GSK Investigational Site
Seoul, 135-720
GSK Investigational Site
Seoul, 138201
GSK Investigational Site
Seoul, 7499
GSK Investigational Site
Suwon-si, Gyeonggi-do, 16388
GSK Investigational Site
Ulsan, 683380
GSK Investigational Site
Yangju-si, Gyeonggi-do, 11456
About this study
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.
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.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- Data collection
- Keywords
- Safety, Post-marketing, Korea, Drug utilization study, Fluarix Tetra
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Data collection | |
| 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). Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start20 Oct 2016
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663102
- Sponsor's protocol ID
- 204687
- Status last verified
- Oct 2023
- First submitted
- 21 Jan 2016
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02663102
- Acronym / sponsor ID
- 204687
- Conditions
- Influenza, Human
- Keywords
- Safety, Post-marketing, Korea, Drug utilization study, Fluarix Tetra
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,388 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluarix Tetra Group 1 | – | Other: Data collectionSubjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation). |
| Fluarix Tetra Group 2 | – | Other: Data collectionSubjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation). |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)].
Key exclusion criteria (5 listed)
- Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.
- Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionSafety 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. | Other | Fluarix Tetra Group 1, Fluarix Tetra Group 2 |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human, run by GlaxoSmithKline at 21 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.