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This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2008-2009 season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluarix Adult Group | Experimental | Subjects who are 18-40 years of age received one dose of Fluarixâ„¢. |
|
| Fluarix Elderly Group | Experimental | Subjects who are ≥ 60 years of age received one dose of Fluarix™. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarixâ„¢ | 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 | At Day 0 and 21 |
| Number of Subjects With HI Antibody Titer Above the Cut-off Value | The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains | At Day 0 and 21 |
| Number of Seroprotected Subjects | A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40 | At Day 0 and 21 |
| Number of Serconverted 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 | At Day 21 |
| Serconversion 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 | At 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 | At Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever | During the 4-day (Day 0-3) post-vaccination period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany | ||
| GSK Investigational Site |
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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 |
|---|---|---|---|
| 111631 | Annotated Case Report Form | 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 | Fluarix Adult Group | Subjects who are 18-40 years of age received one dose of Fluarixâ„¢ |
| FG001 | Fluarix Elderly Group | Subjects who are ≥ 60 years of age received one dose of Fluarix™ |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix Adult Group | Subjects who are 18-40 years of age received one dose of Fluarixâ„¢ |
| BG001 | Fluarix Elderly Group | Subjects who are ≥ 60 years of age received one dose of Fluarix™ |
| 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 | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 0 and 21 |
|
|
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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 | Fluarix Adult Group | Subjects who are 18-40 years of age received one dose of Fluarixâ„¢ |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Induration | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C510903 | fluarix |
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| 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 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. | During the 21-day (Day 0-20) post-vaccination period |
| Dresden |
| Saxony |
| 01099 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01277 | Germany |
| GSK Investigational Site | Freital | Saxony | 01705 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111631 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111631 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111631 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111631 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111631 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111631 | Individual Participant Data Set | 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 |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Subjects With HI Antibody Titer Above the Cut-off Value | The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains | Posted | Number | subjects | At Day 0 and 21 |
|
|
|
| Primary | Number of Seroprotected Subjects | A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40 | Posted | Number | subjects | At Day 0 and 21 |
|
|
|
| Primary | Number of Serconverted 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 | Posted | Number | subjects | At Day 21 |
|
|
|
| Primary | Serconversion 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 | Posted | Number | factor | At 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 According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results | Posted | Number | subjects | At Day 21 |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever | Posted | Number | subjects | 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 | Number | subjects | 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 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 | subjects | During the 21-day (Day 0-20) post-vaccination period |
|
|
|
| 1 |
| 61 |
| 44 |
| 61 |
| EG001 | Fluarix Elderly Group | Subjects who are ≥ 60 years of age received one dose of Fluarix™ | 0 | 59 | 30 | 59 |
| 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 |
|
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/Uruguay (Day 0) |
|
| A/Uruguay (Day 21) |
|
| B/Brisbane (Day 0) |
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| B/Brisbane (Day 21) |
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| A/Uruguay (Day 0) |
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| A/Uruguay (Day 21) |
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| B/Brisbane (Day 0) |
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| B/Brisbane (Day 21) |
|
| B/Brisbane |
|
| B/Brisbane |
|
| B/Brisbane (N=13; 9) |
|
| Pain |
|
| Redness |
|
| Swelling |
|
| Arthralgia |
|
| Fatigue |
|
| Headache |
|
| Myalgia |
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| Shivering |
|
| Sweating |
|
| Fever |
|