Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluarix Adult Group | Experimental | Subjects aged 18 to 60 years received one dose of Fluarixâ„¢. |
|
| Fluarix Elderly Group | Experimental | Subjects aged > 60 years received one dose of Fluarixâ„¢. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix™/Influsplit SSW® | Biological | Single intramuscular dose on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination Inhibition (HI) Antibody Titer | Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains | Day 0 and Day 21 |
| Number of Seroprotected Subjects | A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40 | Day 0 and Day 21 |
| Number of Seroconverted Subjects | A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4 | Day 21 |
| Seroconversion Factor | Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains | Day 21 |
| Seroprotection Power | Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40 | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. | During the 4-day (Day 0-3) post-vaccination period |
| Number of Subjects Reporting Solicited General Symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dresden | Saxony | 01067 | Germany | ||
| GSK Investigational Site |
Not provided
| 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 |
|---|---|---|---|
| 114292 | Individual Participant Data Set | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fluarix Adult Group | Subjects aged 18 to 60 years received one dose of Fluarixâ„¢. |
| FG001 | Fluarix Elderly Group | Subjects aged > 60 years received one dose of Fluarixâ„¢. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix Adult Group | Subjects aged 18 to 60 years received one dose of Fluarixâ„¢. |
| BG001 | Fluarix Elderly Group | Subjects aged > 60 years received one dose of Fluarixâ„¢. |
| 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 | Hemagglutination Inhibition (HI) Antibody Titer | Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains | Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0 and Day 21 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluarix Adult Group | Subjects aged 18 to 60 years received one dose of Fluarixâ„¢. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever. |
| During the 4-day (Day 0-3) post-vaccination period |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE 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 (Day 0-20) post-vaccination period |
| Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is lifethreatening, 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. | During the entire study period (From Day 0 up to Day 21) |
| Dresden |
| Saxony |
| 01069 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01099 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Freital | Saxony | 01705 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114292 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114292 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114292 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114292 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114292 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114292 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Seroprotected Subjects | A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40 | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data | Posted | Count of Participants | Participants | Day 0 and Day 21 |
|
|
|
| Primary | Number of Seroconverted Subjects | A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4 | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data | Posted | Count of Participants | Participants | Day 21 |
|
|
|
| Primary | Seroconversion Factor | Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data | Posted | Mean | 95% Confidence Interval | fold change | Day 21 |
|
|
|
| Primary | Seroprotection Power | Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40 | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data | Posted | Count of Participants | Participants | Day 21 |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. | Analysis was performed on the Total Vaccinated Cohort, on subjects with available data | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever. | Analysis was performed on the Total Vaccinated Cohort, on subjects with available data | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE 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 | Count of Participants | Participants | During the 21-day (Day 0-20) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is lifethreatening, 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 | Count of Participants | Participants | During the entire study period (From Day 0 up to Day 21) |
|
|
|
| 0 |
| 60 |
| 50 |
| 60 |
| EG001 | Fluarix Elderly Group | Subjects aged > 60 years received one dose of Fluarixâ„¢. | 0 | 54 | 30 | 54 |
| Induration | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Arthralgia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Myalgia | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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 |
| A/Victoria (Day 0) |
|
| A/Victoria (Day 21) |
|
| B/Brisbane (Day 0) |
|
| B/Brisbane (Day 21) |
|
| B/Brisbane |
|
| B/Brisbane |
|
| A/Victoria |
|
|
| B/Brisbane |
|
|
| Pain |
|
| Redness |
|
| Swelling |
|
| Headache |
|
| Myalgia |
|
| Shivering |
|
| Fever (Axillary) |
|
| Sweating |
|