Trial · NCT02663102
Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
NCT02663102, Completed, GlaxoSmithKline; results first posted 2024-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea. Trials, record NCT02663102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02663102
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
- NCT number
- NCT02663102
- Status
- Completed
- Enrollment
- 1,388 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza, Human
- Interventions
- Data collection
- First posted
- 2016-01-26
- Last updated
- 2024-04-05
- Results first posted
- 2024-04-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Expected Adverse Events (AEs) | Fluarix Tetra Group 1 | 54 | Participants | ||
| Number of Participants With Expected Adverse Events (AEs) | Fluarix Tetra Group 2 | 44 | Participants | ||
| Number of Participants With Unexpected Adverse Events (AEs) | Fluarix Tetra Group 1 | 116 | Participants | ||
| Number of Participants With Unexpected Adverse Events (AEs) | Fluarix Tetra Group 2 | 62 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Fluarix Tetra Group 1 | 3 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Fluarix Tetra Group 2 | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluarix Tetra Group 1 | 687 | |
| Overall Study | STARTED | Fluarix Tetra Group 2 | 701 | |
| Overall Study | COMPLETED | Fluarix Tetra Group 1 | 687 | |
| Overall Study | COMPLETED | Fluarix Tetra Group 2 | 701 | |
| Overall Study | NOT COMPLETED | Fluarix Tetra Group 1 | 0 | |
| Overall Study | NOT COMPLETED | Fluarix Tetra Group 2 | 0 |
Source ClinicalTrials.gov
Adverse events158
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Fluarix Tetra Group 1 | 49 | 687 | 53 |
| other | Nasopharyngitis | Infections and infestations | Fluarix Tetra Group 2 | 17 | 701 | 17 |
| other | Rhinitis | Infections and infestations | Fluarix Tetra Group 1 | 23 | 687 | 23 |
| other | Rhinitis | Infections and infestations | Fluarix Tetra Group 2 | 4 | 701 | 4 |
| other | Bronchitis | Infections and infestations | Fluarix Tetra Group 1 | 19 | 687 | 19 |
| other | Bronchitis | Infections and infestations | Fluarix Tetra Group 2 | 9 | 701 | 9 |
| other | Acute sinusitis | Infections and infestations | Fluarix Tetra Group 1 | 5 | 687 | 5 |
| other | Acute sinusitis | Infections and infestations | Fluarix Tetra Group 2 | 0 | 701 | 0 |
| other | Otitis media acute | Infections and infestations | Fluarix Tetra Group 1 | 4 | 687 | 4 |
| other | Otitis media acute | Infections and infestations | Fluarix Tetra Group 2 | 0 | 701 | 0 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluarix Tetra Group 1 | 0 | 687 |
| Total, all-cause mortality | Fluarix Tetra Group 2 | 0 | 701 |
| Total, other adverse events | Fluarix Tetra Group 1 | 167 | 687 |
| Total, other adverse events | Fluarix Tetra Group 2 | 105 | 701 |
| Total, serious adverse events | Fluarix Tetra Group 1 | 3 | 687 |
| Total, serious adverse events | Fluarix Tetra Group 2 | 1 | 701 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: Number of Participants With Expected Adverse Events (AEs) | Trial comparisons |
| Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: Number of Participants With Unexpected Adverse Events (AEs) | Trial comparisons |
| Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: deaths from any cause | Trial comparisons |
| Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02663102
GET https://conductscience.org/api/trials/v1/NCT02663102/events?page=2