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The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's FluzoneĀ® (TIV) in children 6 to 35 months of age.
The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluLaval Quadrivalent Group | Experimental | Subjects received 1 or 2 doses of FluLavalĀ® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status. |
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| Fluzone Group | Active Comparator | Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluLavalĀ® Quadrivalent | Biological | 1 or 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm (for subjects ā„12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLavalĀ® Quadrivalent Vaccine. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (ā„) 1:40, or a pre-vaccination titer ā„ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (ā„) 1:40, or a pre-vaccination titer ā„ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. |
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Inclusion Criteria:
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
Child in care.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ā„ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
History of Guillain-BarrƩ syndrome within six weeks of receipt of prior influenza vaccine.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Acute disease and/or fever at the time of enrollment.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sacramento | California | 95822 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 200806 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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2 subjects were allocated subject numbers but study vaccine was not administered, thus were excluded from the study prior to group assignment.
Not all subjects who withdrew from the study were willing to provide a reason for withdrawal. Thus, the reasons for withdrawal for these subjects are unknown.
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| ID | Title | Description |
|---|---|---|
| FG000 | FluLaval Quadrivalent Group | Subjects received 1 or 2 doses of FluLavalĀ® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status. |
| FG001 | Fluzone Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| FluzoneĀ® | Biological | 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ā„12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively. |
|
| 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects) |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively) |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (ā„) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects) |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains. | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects) |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0Ā°C. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Fever | Any fever was defined as any fever ā„38.0 degrees Celsius (Ā°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ā„39.0 Ā°C. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination |
| Duration of Solicited Local and General Symptoms | Duration was defined as number of days with any grade of local and general symptoms. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination |
| Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During the entire study period (Day 0 to Day 180) |
| Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During the entire study period (Day 0 to Day 180) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010 | During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | During the entire study period (Day 0 - Day 180) |
| West Covina |
| California |
| 91790 |
| United States |
| GSK Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| GSK Investigational Site | Fall River | Massachusetts | 02721 | United States |
| GSK Investigational Site | Woburn | Massachusetts | 01801 | United States |
| GSK Investigational Site | Stevensville | Michigan | 49127 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44121 | United States |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | United States |
| GSK Investigational Site | Barnwell | South Carolina | 29812 | United States |
| GSK Investigational Site | Cheraw | South Carolina | 29520 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76135 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 200806 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200806 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200806 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200806 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200806 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200806 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FluLaval Quadrivalent Group | Subjects received 1 or 2 doses of FluLavalĀ® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status. |
| BG001 | Fluzone Group | Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Months |
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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 | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLavalĀ® Quadrivalent Vaccine. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (ā„) 1:40, or a pre-vaccination titer ā„ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects) |
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| Secondary | Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (ā„) 1:40, or a pre-vaccination titer ā„ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects) |
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| Secondary | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively) |
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| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (ā„) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects) |
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| Secondary | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains. | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects) |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0Ā°C. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any fever was defined as any fever ā„38.0 degrees Celsius (Ā°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ā„39.0 Ā°C. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination |
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| Secondary | Duration of Solicited Local and General Symptoms | Duration was defined as number of days with any grade of local and general symptoms. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Median | Full Range | Days | During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination |
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| Secondary | Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During the entire study period (Day 0 to Day 180) |
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| Secondary | Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) | pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During the entire study period (Day 0 to Day 180) |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010 | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination |
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| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available. | Posted | Number | Subjects | During the entire study period (Day 0 - Day 180) |
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Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet 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 | FluLaval Quadrivalent Group | Subjects received 1 or 2 doses of FluLavalĀ® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status. | 5 | 158 | 115 | 158 | ||
| EG001 | Fluzone Group | Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. | 4 | 156 | 103 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment |
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| Abscess neck | Infections and infestations | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Viral infection | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Irritability/fussiness | General disorders | Systematic Assessment |
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| Loss of appetite | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment | Assessed during the 7-day (Days 0-6) post-vaccination period |
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| Fever | General disorders | Systematic Assessment | Assessed duringthe 4-day (Days 0-3) post-vaccination period |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Otitis media | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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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 |
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| Yamagata [Day 28 = primed and Day 56 = unprimed] |
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| Victoria [Day 28 = primed and Day 56 = unprimed] |
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Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. |
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| Units | Counts |
|---|---|
| Participants |
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Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Fluzone Group |
Subjects received 1 or 2 doses of FluzoneĀ® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. |
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