Influenza, Human
Conditions
Keywords
Safety, Post-marketing, Korea, Drug utilization study, Fluarix Tetra
Brief 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.
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.
Interventions
OTHERData 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.
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Expected Adverse Events (AEs) | 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) | 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) | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 687 |
| 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). | 701 |
| Total | 1,388 |
Baseline characteristics
| Characteristic | Fluarix Tetra Group 1 | Fluarix Tetra Group 2 | Total |
|---|---|---|---|
| Age, Customized 10 years - 19 years | 0 Participants | 89 Participants | 89 Participants |
| Age, Customized >1 year - <2 years | 233 Participants | 0 Participants | 233 Participants |
| Age, Customized 20 years - 29 years | 0 Participants | 56 Participants | 56 Participants |
| Age, Customized >2 years - < 3 years | 179 Participants | 0 Participants | 179 Participants |
| Age, Customized 30 years - 39 years | 0 Participants | 108 Participants | 108 Participants |
| Age, Customized 3 years - 9 years | 0 Participants | 167 Participants | 167 Participants |
| Age, Customized 40 years - 49 years | 0 Participants | 104 Participants | 104 Participants |
| Age, Customized 50 years or more | 0 Participants | 177 Participants | 177 Participants |
| Age, Customized 6 months - 11 months | 275 Participants | 0 Participants | 275 Participants |
| Race/Ethnicity, Customized Korean | 686 Participants | 701 Participants | 1387 Participants |
| Race/Ethnicity, Customized Non-Korean | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 323 Participants | 376 Participants | 699 Participants |
| Sex: Female, Male Male | 364 Participants | 325 Participants | 689 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 687 | 0 / 701 |
| other Total, other adverse events | 167 / 687 | 105 / 701 |
| serious Total, serious adverse events | 3 / 687 | 1 / 701 |
Outcome results
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.
Time frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Population: The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix Tetra Group 1 | Number of Participants With Expected Adverse Events (AEs) | 54 Participants |
| Fluarix Tetra Group 2 | Number of Participants With Expected Adverse Events (AEs) | 44 Participants |
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.
Time frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Population: The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix Tetra Group 1 | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Fluarix Tetra Group 2 | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
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.
Time frame: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Population: The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix Tetra Group 1 | Number of Participants With Unexpected Adverse Events (AEs) | 116 Participants |
| Fluarix Tetra Group 2 | Number of Participants With Unexpected Adverse Events (AEs) | 62 Participants |