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The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flulaval Group | Experimental | subjects received Flulavalâ„¢ vaccine according to their priming status and age:
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| Fluzone Group | Active Comparator | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK investigational vaccine GSK1557482A | Biological | One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). | At Day 0 and 28 after last vaccine dose. |
| Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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. | At Day 28 after last vaccine dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | At Day 0 and 28 after last vaccine dose. |
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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 | Birmingham | Alabama | 35205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29465480 | Derived | Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949. | |
| 22333695 | Derived | Domachowske JB, Blatter M, Chandrasekaran V, Liu A, Jain VK, Fries L. A randomized, controlled trial in children to assess the immunogenicity and safety of a thimerosal-free trivalent seasonal influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924. |
| 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 |
|---|---|---|---|
| 112999 | 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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Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flulaval Group | subjects received Flulavalâ„¢ vaccine according to their priming status and age:
|
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluzone® | Biological | One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects |
|
| Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | At Day 28 after last vaccine dose. |
| Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. | At Day 0 and 28 after last vaccine dose. |
| Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | At Day 0 and 28 after last vaccine dose. |
| Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. | At Day 0 and at Day 28 after last vaccine dose |
| Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | At Day 0 and at Day 28 after last vaccine dose |
| Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination. | During a 4-day follow-up period (Days 0-3) after vaccination. |
| Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination. | During a 4-day follow-up period (Days 0-3) after vaccination. |
| Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. | During a 4-day follow-up period (Days 0-3) after vaccination. |
| Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | During a 4-day follow-up period (Days 0-3) after vaccination. |
| Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | During a 28 day follow-up period (Days 0-27) after vaccination. |
| Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | During a 28 day follow-up period (Days 0-27) after vaccination. |
| Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. | During the entire study period (From Day 0 up to Day 180). |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | During the entire study period (From Day 0 up to Day 180). |
| Benton |
| Arkansas |
| 72015 |
| United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | West Covina | California | 91790 | United States |
| GSK Investigational Site | Marietta | Georgia | 30062 | United States |
| GSK Investigational Site | Woodstock | Georgia | 30189 | United States |
| GSK Investigational Site | DeKalb | Illinois | 60115 | United States |
| GSK Investigational Site | Newton | Kansas | 67114 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Woburn | Massachusetts | 01801 | United States |
| GSK Investigational Site | Stevensville | Michigan | 49127 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Henderson | Nevada | 89015 | United States |
| GSK Investigational Site | Cortland | New York | 13045 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Cary | North Carolina | 27518 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Austintown | Ohio | 44515 | United States |
| GSK Investigational Site | Albany | Oregon | 97322 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16505 | United States |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Houston | Texas | 77055 | United States |
| GSK Investigational Site | Orem | Utah | 84057 | United States |
| GSK Investigational Site | Provo | Utah | 84604 | United States |
| GSK Investigational Site | Burke | Virginia | 22015 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112999 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112999 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112999 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112999 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112999 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112999 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Fluzone Group |
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flulaval Group | subjects received Flulavalâ„¢ vaccine according to their priming status and age:
|
| BG001 | Fluzone Group | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 and 28 after last vaccine dose. |
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| Primary | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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 According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 28 after last vaccine dose. |
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| Secondary | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 and 28 after last vaccine dose. |
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| Secondary | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 28 after last vaccine dose. |
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| Secondary | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 0 and 28 after last vaccine dose. |
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| Secondary | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Count of Participants | Participants | At Day 0 and 28 after last vaccine dose. |
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| Secondary | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Mean | 95% Confidence Interval | Fold change | At Day 0 and at Day 28 after last vaccine dose |
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| Secondary | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Posted | Mean | 95% Confidence Interval | Fold change | At Day 0 and at Day 28 after last vaccine dose |
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| Secondary | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 4-day follow-up period (Days 0-3) after vaccination. |
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| Secondary | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 4-day follow-up period (Days 0-3) after vaccination. |
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| Secondary | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 4-day follow-up period (Days 0-3) after vaccination. |
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| Secondary | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 4-day follow-up period (Days 0-3) after vaccination. |
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| Secondary | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 28 day follow-up period (Days 0-27) after vaccination. |
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| Secondary | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 28 day follow-up period (Days 0-27) after vaccination. |
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| Secondary | Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (From Day 0 up to Day 180). |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (From Day 0 up to Day 180). |
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Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-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 | Flulaval Group | subjects received Flulavalâ„¢ vaccine according to their priming status and age:
| 10 | 1,055 | 742 | 1,055 | ||
| EG001 | Fluzone Group | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
| 6 | 1,061 | 710 | 1,061 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Herpangina | Infections and infestations | Non-systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
| ||
| Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Affective disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Attention deficit/hyperactivity disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Forearm fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| H1N1 influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oppositional defiant disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinus polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Type 1 diabetes mellitus | Immune system disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unsolicited AE |
| |
| Pyrexia | General disorders | Non-systematic Assessment | Unsolicited AE |
| |
| Arthralgia | General disorders | Systematic Assessment | Solicited general AE: Subjects of 5 years of age and above |
| |
| Fatigue | General disorders | Systematic Assessment | Solicited general AE: Subjects of 5 years of age and above |
| |
| Headache | General disorders | Systematic Assessment | Solicited general AE: Subjects of 5 years of age and above |
| |
| Muscle aches | General disorders | Systematic Assessment | Solicited general AE: Subjects of 5 years of age and above |
| |
| Shivering | General disorders | Systematic Assessment | Solicited general AE: Subjects of 5 years of age and above |
| |
| Drowsiness | General disorders | Systematic Assessment | Solicited general AE: Subjects below 5 years of age |
| |
| Irritability | General disorders | Systematic Assessment | Solicited general AE: Subjects below 5 years of age |
| |
| Loss of appetite | General disorders | Systematic Assessment | Solicited general AE: Subjects below 5 years of age |
| |
| Temperature | General disorders | Systematic Assessment | Solicited general AE: Subjects below 5 years of age. Temperature = axillary temperature equal to or above 38.0 degrees Celsius (°C). |
| |
| Pain | General disorders | Systematic Assessment | Solicited local AE |
| |
| Redness | General disorders | Systematic Assessment | Solicited local AE |
| |
| Swelling | General disorders | Systematic Assessment | Solicited local AE |
|
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.
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| A/Brisbane [at Day 28] |
|
|
| A/Uruguay [at Day 0] |
|
|
| A/Uruguay [at Day 28] |
|
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| B/Brisbane [at Day 0] |
|
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| B/Brisbane [at Day 28] |
|
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| OG002 | Flulaval Less Than 5 Years Old Group | Subjects below 5 years of age and who received 1 or 2 injections of Flulavalâ„¢ vaccine according to their priming status. |
| OG003 | Fluzone Les Than 5 Years Old Group | Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age |
|
|
| OG002 | Flulaval 5 Years of Age and Older Group | Subjects aged 5 years and above and who received 1 or 2 injections of Flulavalâ„¢ vaccine according to their priming status. |
| OG003 | Fluzone 5 Years of Age and Older Group | Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age |
|
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