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The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unprimed, > 6 to < 72 Months | Experimental | Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed). |
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| Unprimed, ≥ 72 to < 108 Months | Experimental | Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed). |
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| Primed, > 6 to < 72 Months | Experimental | Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). |
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| Primed, ≥ 72 to < 108 Months | Experimental | Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). |
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| Primed, ≥ 108 to < 216 Months | Experimental | Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). |
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| Primed, ≥ 216 Months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluarixTM | Biological | All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Severe Unsolicited Adverse Events | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities | During the 21-day follow-up period (Day 0 to Day 20) after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis. | During the 4-day follow up (Day 0 to 3) after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 218352/054 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unprimed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed). |
| FG001 | Unprimed, ≥ 72 to < 108 Months | Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed). |
| FG002 | Primed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). |
| FG003 | Primed, ≥ 72 to < 108 Months | Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). |
| FG004 | Primed, ≥ 108 to < 216 Months | Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). |
| FG005 | Primed, ≥ 216 Months | Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Unprimed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed). |
| BG001 | Unprimed, ≥ 72 to < 108 Months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Severe Unsolicited Adverse Events | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities | Posted | Number | participants | During the 21-day follow-up period (Day 0 to Day 20) after vaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unprimed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kawasaki's disease | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Experimental |
Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). |
|
| Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis. | During the 4-day follow up (Day 0 to 3) after vaccination. |
| Number of Participant Reporting Unsolicited Adverse Events. | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | During the 21-day follow-up period (Day 0 to Day 20) after vaccination |
| Number of Participants Reporting Serious Adverse Events (SAE). | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Within 1 month following vaccination |
For additional information about this study please refer to the GSK Clinical Study Register |
| 218352/054 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 218352/054 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 218352/054 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 218352/054 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 218352/054 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
| BG002 | Primed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). |
| BG003 | Primed, ≥ 72 to < 108 Months | Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). |
| BG004 | Primed, ≥ 108 to < 216 Months | Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). |
| BG005 | Primed, ≥ 216 Months | Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). |
| BG006 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Primed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). |
| OG003 | Primed, ≥ 72 to < 108 Months | Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). |
| OG004 | Primed, ≥ 108 to < 216 Months | Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). |
| OG005 | Primed, ≥ 216 Months | Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). |
|
|
| Secondary | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis. | Posted | Number | participants | During the 4-day follow up (Day 0 to 3) after vaccination. |
|
|
|
| Secondary | Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. | Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis. | Posted | Number | participants | During the 4-day follow up (Day 0 to 3) after vaccination. |
|
|
|
| Secondary | Number of Participant Reporting Unsolicited Adverse Events. | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Posted | Number | participants | During the 21-day follow-up period (Day 0 to Day 20) after vaccination |
|
|
|
| Secondary | Number of Participants Reporting Serious Adverse Events (SAE). | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Posted | Number | participants | Within 1 month following vaccination |
|
|
|
| 1 |
| 294 |
| 9 |
| 294 |
| EG001 | Unprimed, ≥ 72 to < 108 Months | Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed). | 0 | 1 | 0 | 1 |
| EG002 | Primed, > 6 to < 72 Months | Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). | 0 | 384 | 90 | 384 |
| EG003 | Primed, ≥ 72 to < 108 Months | Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). | 0 | 79 | 27 | 79 |
| EG004 | Primed, ≥ 108 to < 216 Months | Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). | 0 | 46 | 10 | 46 |
| EG005 | Primed, ≥ 216 Months | Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). | 0 | 71 | 11 | 71 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
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| Induration | General disorders | Systematic Assessment |
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| Fatigue | General disorders |
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| Headache | Nervous system disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Redness |
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| Swelling |
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| Fever |
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| Shivering |
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| Sweating/diaphoresis |
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| Redness |
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| Swelling |
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| Induration |
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| Fatigue |
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| Fever |
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| Headache |
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| Malaise |
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| Myalgia |
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| Shivering |
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| Sweating/diaphoresis |
|