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This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2282512A 1 Group | Experimental | Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Victoria strain Fluarix Group | Active Comparator | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Yamagata strain Fluarix Group | Active Comparator | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK2282512A 2 Group | Experimental | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent seasonal influenza vaccine GSK2282512A | Biological | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Number of Subjects Seroconverted Against 4 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 vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. |
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Inclusion Criteria:
Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
Written informed assent obtained from the subject if/as required by local regulations.
Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject
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 | Chandler | Arizona | 85224 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23847058 | Derived | Langley JM, Carmona Martinez A, Chatterjee A, Halperin SA, McNeil S, Reisinger KS, Aggarwal N, Huang LM, Peng CT, Garcia-Sicilia J, Salamanca de la Cueva I, Cabanas F, Trevino-Garza C, Rodriguez-Weber MA, de la O M, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. J Infect Dis. 2013 Aug 15;208(4):544-53. doi: 10.1093/infdis/jit263. Epub 2013 Jul 11. |
| 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 |
|---|---|---|---|
| 113314 | Dataset Specification | 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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Unprimed Subjects - subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season - received a 2-dose vaccination course. Primed Subjects - all other subjects - received a 1-dose vaccination course.
A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2282512A 1 Group | Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | Victoria Strain Fluarix Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluarixâ„¢ VB | Biological | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose. |
|
| Fluarixâ„¢ YB | Biological | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose |
|
| Quadrivalent seasonal influenza vaccine GSK2282512A | Biological | Single intramuscular dose for primed subjects, two doses for unprimed subjects. |
|
| At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | 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 vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm). | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Days With Solicited Local Symptoms After Vaccination | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling. | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination. | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination. | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite. | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering. | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively. | During the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination. | During the 28-day follow-up period (Day 0-27) after vaccination |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination. | During the entire study period (from Day 0 to Day 180) |
| Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs. | During the entire study period (from Day 0 to Day 180) |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | 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(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. | During the entire study period (from Day 0 to Day 180) |
| Scottsdale |
| Arizona |
| 85288 |
| United States |
| GSK Investigational Site | Harrisburg | Arkansas | 72432 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Centennial | Colorado | 80112 | United States |
| GSK Investigational Site | Longmont | Colorado | 80501 | United States |
| GSK Investigational Site | Thornton | Colorado | 80233 | United States |
| GSK Investigational Site | Niles | Michigan | 49120 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | United States |
| GSK Investigational Site | Barnwell | South Carolina | 29812 | United States |
| GSK Investigational Site | Clarksville | Tennessee | 37043 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76135 | United States |
| GSK Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| GSK Investigational Site | Surrey | British Columbia | V3R 8P8 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| GSK Investigational Site | Mount Pearl | Newfoundland and Labrador | A1N 5B6 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8L 5G8 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| GSK Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| GSK Investigational Site | Mexico City | 04530 | Mexico |
| GSK Investigational Site | Alcalá de Guadaira | 41500 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Pozuelo de Alarcón/Madrid | 28223 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| GSK Investigational Site | Taichung | 404 | Taiwan |
| GSK Investigational Site | Taipei | 100 | Taiwan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113314 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113314 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113314 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113314 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113314 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113314 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2282512A 1 Group | Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | Victoria Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
| BG004 | 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 | ||||||||||
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| 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 | ||||||||||||||||||||||||
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| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible 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 | titer | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Primary | Number of Subjects Seroconverted Against 4 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 vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available. | Posted | Count of Participants | Participants | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible 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 | titer | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible 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 | Count of Participants | Participants | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains | The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible 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 | titer | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata | 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 vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available. | Posted | Count of Participants | Participants | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible 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 | Count of Participants | Participants | At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months. | The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Days With Solicited Local Symptoms After Vaccination | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. | Posted | Median | Inter-Quartile Range | Days | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite. | The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom. | Posted | Median | Inter-Quartile Range | Days | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above | Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering. | The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom. | Posted | Median | Inter-Quartile Range | Days | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination | Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively. | The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom. | Posted | Median | Inter-Quartile Range | Days | During the 7-day follow-up period (Days 0-6) after vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | During the 28-day follow-up period (Day 0-27) after vaccination |
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| Secondary | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Day 180) |
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| Secondary | Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination | Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Day 180) |
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| Secondary | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | 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(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. | The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Day 180) |
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Serious adverse events were assessed from Day 0 to Day 180. Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during a 7-day and 28-day post-vaccination period, respectively.
For the systematically-assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
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 | GSK2282512A 1 Group | Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 3 | 932 | 731 | 932 | ||
| EG001 | Victoria Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 6 | 929 | 666 | 929 | ||
| EG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 5 | 932 | 659 | 932 | ||
| EG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. | 7 | 301 | 233 | 301 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Accidental overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Biliary dyskinesia | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
| ||
| Facial bones fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Foreign body | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | Non-systematic Assessment |
| ||
| Grand mal convulsion | Nervous system disorders | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Lobar pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia viral | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Traumatic brain injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Vitello-intestinal duct remnant | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
| ||
| Drowsiness | General disorders | Systematic Assessment | Assessed in subjects less than 5 years of age in all study Groups. |
| |
| Irritability | General disorders | Systematic Assessment | Assessed in subjects less than 5 years of age in all study Groups. |
| |
| Loss of appetite | General disorders | Systematic Assessment | Assessed in subjects less than 5 years of age in all study Groups. |
| |
| Temperature | General disorders | Systematic Assessment | Assessed in subjects less than 5 years of age in all study Groups. |
| |
| Fatigue | General disorders | Systematic Assessment | Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group. |
| |
| Gastrointestinal | General disorders | Systematic Assessment | Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group. |
| |
| Headache | General disorders | Systematic Assessment | Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group. |
| |
| Joint pain at other location | General disorders | Systematic Assessment | Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group. |
| |
| Muscle aches | General disorders | Systematic Assessment | Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group. |
| |
| Shivering | General disorders | Systematic Assessment | Assessed in subjects 5 years of age and above in GSK2282512A 1 Group, Victoria strain Fluarix Group and Yamagata strain Fluarix Group. |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal 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.
| 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
| Male |
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| H3N2, POST |
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| Victoria, POST |
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| Yamagata, POST |
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| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Victoria Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | Victoria Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | Yamagata Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG005 | Yamagata Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG006 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Victoria Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | Victoria Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | Yamagata Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG005 | Yamagata Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG006 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Victoria Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | Victoria Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | Yamagata Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG005 | Yamagata Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG006 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG002 | Victoria Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | Victoria Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ VB vaccine at Day 0 and Day 28. The Fluarixâ„¢ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | Yamagata Strain Fluarix (3-8 Years) Group | Subjects, 3 to 8 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG005 | Yamagata Strain Fluarix (9-17 Years) Group | Subjects, 9 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG006 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
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|
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Yamagata Strain Fluarix Group |
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 |
| Yamagata Strain Fluarix Group |
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 |
| Yamagata Strain Fluarix Group |
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 | Yamagata Strain Fluarix Group | Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
|
|
| OG002 |
| Yamagata Strain Fluarix Group |
Subjects, 3 to 17 years old, received 1 dose of Fluarixâ„¢ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarixâ„¢ YB vaccine at Day 0 and Day 28. The Fluarixâ„¢ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | GSK2282512A 2 Group | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. |
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