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The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK 1388442A Group | Experimental | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Fluarix Group | Active Comparator | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent influenza vaccine GSK 138842A | Biological | IM injection on Day 0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Solicited Local Symptoms. | Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. | During the 7-day (Days 0-6) post vaccination period |
| Number of Subjects With Solicited General Symptoms. | Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. | During the 7-day (Days 0-6) post vaccination period |
| Number of Subjects With Medically Attended Adverse Events (MAEs). | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination. | During the entire study period (Days 0-182) |
| Number of Subjects With New Onset of Chronic Diseases (NOCDs). | NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies. | During the entire study period (Days 0-182) |
| Number of Subjects With Unsolicited Adverse Events (AEs). | Unsolicited AEs cover 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. | During the 90-day (Days 0-89) 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 | Miami | Florida | 33143 | United States | ||
| 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 |
|---|---|---|---|
| 110127 | Study Protocol | 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 | GSK 1388442A Group | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | Fluarix Group | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK 1388442A Group | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | Fluarix Group |
| 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 Subjects With Solicited Local Symptoms. | Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed). | Posted | Number | subjects | During the 7-day (Days 0-6) post vaccination period |
|
SAE(s): during the entire study period (Days 0-182); Unsolicited AE(s): during the 90-day (Days 0-89) post-vaccination period; Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period.
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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 | GSK 1388442A Group | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions |
| 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 |
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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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| Fluarix |
| Biological |
IM injection on Day 0 |
|
| Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. | During the entire study period (Days 0-182) |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 |
| Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. | GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 0 and Day 21 |
| Lenexa |
| Kansas |
| 66219 |
| United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110127 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110127 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110127 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110127 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110127 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110127 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Fluarix Group |
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Primary | Number of Subjects With Solicited General Symptoms. | Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed). | Posted | Number | subjects | During the 7-day (Days 0-6) post vaccination period |
|
|
|
| Primary | Number of Subjects With Medically Attended Adverse Events (MAEs). | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the entire study period (Days 0-182) |
|
|
|
| Primary | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the entire study period (Days 0-182) |
|
|
|
| Primary | Number of Subjects With Unsolicited Adverse Events (AEs). | Unsolicited AEs cover 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. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the 90-day (Days 0-89) post-vaccination period |
|
|
|
| Primary | Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the entire study period (Days 0-182) |
|
|
|
| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Day 21 |
|
|
|
| Primary | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Number | subjects | At Day 21 |
|
|
|
| Primary | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Number | subjects | At Day 21 |
|
|
|
| Primary | Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. | GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | At Day 0 and Day 21 |
|
|
|
| 1 |
| 101 |
| 64 |
| 101 |
| EG001 | Fluarix Group | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 0 | 99 | 63 | 99 |
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Muscle aches | 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 |
| Headache |
|
| Muscle aches |
|
| Shivering |
|
| Temperature ≥ 38.0°C |
|
| MALAY. |
|
| MALAY. |
|
| MALAY. |
|
| MALAY. |
|