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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015011-41 | EudraCT Number |
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The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects receiving alternative dose of GSK23440272A vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK investigational vaccine GSK2340272A | Biological | Three intramuscular injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). | At Day 0, Day 21 and Day 42 |
| Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | At Day 42 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years. | At Day 42 |
| HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years | At Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as geometric mean titers (GMTs) | At Month 6 |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21504774 | Background | Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17. | |
| 26176592 | Background |
| 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 |
|---|---|---|---|
| 113638 | Informed Consent Form | View IPD |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
One subject was enrolled but not vaccinated and therefore, was not included in the number of subjects under "STARTED"
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| ID | Title | Description |
|---|---|---|
| FG000 | Flu BS1_3-5 Years Group | Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). |
| FG001 | Flu BS1_6-9 Years Group | Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). |
| FG002 | Flu BS1_10-17 Years Group | Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). |
| FG003 | Flu BS2_3-5 Years Group | Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). |
| FG004 | Flu BS2_6-9 Years Group | Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). |
| FG005 | Flu BS2_10-17 Years Group | Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Subjects receiving alternative dose of GSK23440272A vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). | The ATP cohort for immunogenicity included all subjects for whom 2 doses were administrated and assay results were available for the blood samples taken before the first vaccination (Day 0), before the second vaccination (Day 21) and after the second vaccine dose (Day 42). No blood samples were planned at Day 0 and Day 21 for Flu BS2 Groups. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0, Day 21 and Day 42 |
|
SAEs:During the entire study period (Day 0 to Month 6), Solicited local and general symptoms:During the 7-day (Days 0-6) post-vaccination period;Unsolicited symptoms:Within the 84-day or from 63-day follow-up period after the 1st and 2nd dose,respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flu BS1_3-5 Years Group | Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Antibody titers were expressed as geometric mean titers (GMTs) |
| At Month 12 |
| Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | At Month 6 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years. | At Month 6 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years. | At Month 12 |
| HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years | At Month 6 |
| Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). | At Day 0, Day 21, Day 42 and Month 6 |
| Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). | At Month 12 |
| Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | At Day 21 and Day 42 |
| Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | At Month 6 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm. | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C. | During the 7-day (Days 0-6) post-vaccination period |
| 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. | During the entire study period (Day 0 to Month 12) |
| Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (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 etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject. | During the entire study period (Day 0 to Month 12) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE was defined as any AE (i.e. any 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) 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. | Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was 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. | During the entire study period (Day 0 to Month 12) |
| Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN) | Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards. | At Day 0, Day 21, Day 42 and Month 6 (M6) |
| Schwäbisch Hall |
| Baden-Wurttemberg |
| 74523 |
| Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | Germany |
| GSK Investigational Site | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113638 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113638 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113638 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113638 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113638 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113638 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Flu BS1_6-9 Years Group | Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). |
| OG002 | Flu BS1_10-17 Years Group | Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). |
| OG003 | Flu BS2_3-5 Years Group | Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). |
| OG004 | Flu BS2_6-9 Years Group | Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). |
| OG005 | Flu BS2_10-17 Years Group | Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). |
|
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| Primary | Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion at Day 42 could not be computed for those groups. | Posted | Count of Participants | Participants | At Day 42 |
|
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| Primary | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years. | The ATP cohort for immunogenicity included all evaluable subjects for whom 2 doses were administrated and assay results were available for antibodies against H1N1 antigen for the blood sample taken after the second vaccine dose (Day 42). | Posted | Count of Participants | Participants | At Day 42 |
|
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|
| Primary | HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years | This measure was assessed on the ATP cohort for immunogenicity on subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, GMFR at Day 42 could not be computed for those groups. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Day 42 |
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| Secondary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as geometric mean titers (GMTs) | The ATP cohort for antibody persistence at Month 6 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available for antibodies against the study vaccine antigen component at Month 6. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 6 |
|
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| Secondary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as geometric mean titers (GMTs) | The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, GMTs could not be computed for those groups. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 12 |
|
|
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| Secondary | Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available at pre-vaccination time points (Day 0 and Day 21) and post-vaccination time point (Month 6). No pre-vaccination blood samples were taken from Flu BS2 Groups and hence seroconversion could not be assessed for these groups. | Posted | Count of Participants | Participants | At Month 6 |
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| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years. | The ATP cohort for antibody persistence at Month 6 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6. | Posted | Count of Participants | Participants | At Month 6 |
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| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years. | The ATP cohort for antibody persistence at Month 12 including all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12. As no blood samples were planned at Month 12 for the Flu BS1 Groups, no data were computed for these groups. | Posted | Count of Participants | Participants | At Month 12 |
|
|
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| Secondary | HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years | The ATP cohort for antibody persistence at Month 6 including all subjects for whom assay results were available for antibodies against the study vaccine antigen component pre-vaccination (Day 0 and Day 21) and at Month 6. As no pre-vaccination blood samples were planned for the Flu BS2 Groups, GMFR at Month 6 could not be computed for those groups. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Month 6 |
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| Secondary | Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). | The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at the considered time points. No blood samples were taken at Day 0 and Day 21 and hence no GMTs computed for the Flu BS2 Groups. This analysis was conducted on a randomly selected subset of one third of the subjects. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0, Day 21, Day 42 and Month 6 |
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| Secondary | Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain | Antibody titers were expressed as Geometric mean titers (GMTs). | The ATP cohort for immunogenicity including all evaluable subjects for whom assay results were available at Month 12. No blood samples were planned at Month 12 the Flu BS1 Groups and hence no GMTs computed for these Groups. This analysis was conducted on a randomly selected subset of one third of the subjects. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 12 |
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| Secondary | Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | The ATP cohort for immunogenicity including subjects with assay results available for Day 0, Day 21 and Day 42. As no pre-vaccination (Day 0 and Day 21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was conducted on a randomly selected subset of one third of the subjects. | Posted | Count of Participants | Participants | At Day 21 and Day 42 |
|
|
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| Secondary | Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years. | The ATP cohort for antibody persistence at Month 6 including subjects with assay results available for Day 0, Day 21 and Month 6. As no pre-vaccination (Day 0/21) blood samples were planned for the Flu BS2 Groups, seroconversion could not be computed for those groups. This analysis was done on a randomly selected subset of a third of the subjects. | Posted | Count of Participants | Participants | At Month 6 |
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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 any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm. | The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C. | The Total Vaccinated cohort including all vaccinated subjects who returned their symptom sheet. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
|
|
|
| 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. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (Day 0 to Month 12) |
|
|
|
| Secondary | Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (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 etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (Day 0 to Month 12) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE was defined as any AE (i.e. any 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) 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. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination |
|
|
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| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was 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. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (Day 0 to Month 12) |
|
|
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| Secondary | Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN) | Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards. | The Total Vaccinated cohort including all vaccinated subjects with data available for the respective assays at the considered timepoints. Note that for Flu BS2 Groups, no blood samples were taken at Day 0 and Day 21 and hence no data for these timepoints are reported for the Flu BS2 Groups. | Posted | Count of Participants | Participants | At Day 0, Day 21, Day 42 and Month 6 (M6) |
|
|
|
| 1 |
| 31 |
| 30 |
| 31 |
| EG001 | Flu BS1_6-9 Years Group | Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). | 1 | 31 | 25 | 31 |
| EG002 | Flu BS1_10-17 Years Group | Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 0 (before the first vaccination); On Day 21 (before the second vaccination); On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination). | 1 | 60 | 56 | 60 |
| EG003 | Flu BS2_3-5 Years Group | Subjects 3 to 5 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). | 1 | 30 | 26 | 30 |
| EG004 | Flu BS2_6-9 Years Group | Subjects 6 to 9 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). | 0 | 34 | 26 | 34 |
| EG005 | Flu BS2_10-17 Years Group | Subjects 10 to 17 years of age, received 2 doses of the GSK2340272A vaccine (Flu) at Day 0 and Day 21 with blood sampling schedule as follows: On Day 42 (21 days after the second vaccination); At Month 6 (6 months after the first vaccination); At Month 12 (one year after the first vaccination). | 3 | 58 | 50 | 58 |
| Facial bones fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Ranula | Gastrointestinal disorders | Systematic Assessment |
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| Febrile infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Lice infestation | Infections and infestations | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Otitis externa | Infections and infestations | Systematic Assessment |
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| Otitis media | Infections and infestations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Viral infection | Infections and infestations | 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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| H1N1, Day 21 |
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| H1N1, Day 42 |
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| H1N1, Month 6 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Title | Measurements |
|---|---|
|
| Related Arthralgia |
|
| Any Diarrhoea |
|
| Grade 3 Diarrhoea |
|
| Related Diarrhoea |
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| Any Drowsiness |
|
| Grade 3 Drowsiness |
|
| Related Drowsiness |
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| Any Fatigue |
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| Grade 3 Fatigue |
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| Related Fatigue |
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| Any Gastro-intestinal symptoms |
|
| Grade 3 Gastro-intestinal symptoms |
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| Related Gastro-intestinal symptoms |
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| Any Headache |
|
| Grade 3 Headache |
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| Related Headache |
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| Any Irritability |
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| Grade 3 Irritability |
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| Related Irritability |
|
| Any Loss of appetite |
|
| Grade 3 Loss of appetite |
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| Related Loss of appetite |
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| Any Myalgia |
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| Grade 3 Myalgia |
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| Related Myalgia |
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| Any Shivering |
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| Grade 3 Shivering |
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| Related Shivering |
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| Any Sweating |
|
| Grade 3 Sweating |
|
| Related Sweating |
|
| Any Fever (≥37.5°C) |
|
| Grade 3 Fever (>39°C) |
|
| Related Fever |
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| Title | Measurements |
|---|---|
|
| Related AE(s) |
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| Related SAE(s) |
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| ALAT, Day 0 Below |
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| ALAT, Day 0 Within |
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| ALAT, Day 0 Above |
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| ALAT, Day 21 Unknown |
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| ALAT, Day 21 Below |
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| ALAT, Day 21 Within |
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| ALAT, Day 21 Above |
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| ALAT, Day 42 Unknown |
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| ALAT, Day 42 Below |
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| ALAT, Day 42 Within |
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| ALAT, Day 42 Above |
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| ALAT, M6 Unknown |
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| ALAT, M6 Below |
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| ALAT, M6 Within |
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| ALAT, M6 Above |
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| ASAT, Day 0 Unknown |
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| ASAT, Day 0 Below |
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| ASAT, Day 0 Within |
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| ASAT, Day 0 Above |
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| ASAT, Day 21 Unknown |
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| ASAT, Day 21 Below |
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| ASAT, Day 21 Within |
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| ASAT, Day 21 Above |
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| ASAT, Day 42 Unknown |
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| ASAT, Day 42 Below |
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| ASAT, Day 42 Within |
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| ASAT, Day 42 Above |
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| ASAT, M6 Unknown |
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| ASAT, M6 Below |
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| ASAT, M6 Within |
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| ASAT, M6 Above |
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| Total Bilirubin, Day 0 Unknown |
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| Total Bilirubin, Day 0 Below |
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| Total Bilirubin, Day 0 Within |
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| Total Bilirubin, Day 0 Above |
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| Total Bilirubin, Day 21 Unknown |
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| Total Bilirubin, Day 21 Below |
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| Total Bilirubin, Day 21 Within |
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| Total Bilirubin, Day 21 Above |
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| Total Bilirubin, Day 42 Unknown |
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| Total Bilirubin, Day 42 Below |
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| Total Bilirubin, Day 42 Within |
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| Total Bilirubin, Day 42 Above |
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| Total Bilirubin, M6 Unknown |
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| Total Bilirubin, M6 Below |
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| Total Bilirubin, M6 Within |
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| Total Bilirubin, M6 Above |
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| Bilirubin Conjugated / Direct, Day 0 Unknown |
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| Bilirubin Conjugated / Direct, Day 0 Below |
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| Bilirubin Conjugated / Direct, Day 0 Within |
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| Bilirubin Conjugated / Direct, Day 0 Above |
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| Bilirubin Conjugated / Direct, Day 21 Unknown |
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| Bilirubin Conjugated / Direct, Day 21 Below |
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| Bilirubin Conjugated / Direct, Day 21 Within |
|
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| Bilirubin Conjugated / Direct, Day 21 Above |
|
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| Bilirubin Conjugated / Direct, Day 42 Unknown |
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| Bilirubin Conjugated / Direct, Day 42 Below |
|
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| Bilirubin Conjugated / Direct, Day 42 Within |
|
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| Bilirubin Conjugated / Direct, Day 42 Above |
|
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| Bilirubin Conjugated / Direct, M6 Unknown |
|
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| Bilirubin Conjugated / Direct, M6 Below |
|
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| Bilirubin Conjugated / Direct, M6 Within |
|
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| Bilirubin Conjugated / Direct, M6 Above |
|
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| Creatine, Day 0 Unknown |
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| Creatine, Day 0 Below |
|
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| Creatine, Day 0 Within |
|
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| Creatine, Day 0 Above |
|
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| Creatine, Day 21 Unknown |
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| Creatine, Day 21 Below |
|
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| Creatine, Day 21 Within |
|
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| Creatine, Day 21 Above |
|
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| Creatine, Day 42 Unknown |
|
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| Creatine, Day 42 Below |
|
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| Creatine, Day 42 Within |
|
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| Creatine, Day 42 Above |
|
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| Creatine, M6 Unknown |
|
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| Creatine, M6 Below |
|
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| Creatine, M6 Within |
|
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| Creatine, M6 Above |
|
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| BUN, Day 0 Unknown |
|
|
| BUN, Day 0 Below |
|
|
| BUN, Day 0 Within |
|
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| BUN, Day 0 Above |
|
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| BUN, Day 21 Unknown |
|
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| BUN, Day 21 Below |
|
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| BUN, Day 21 Within |
|
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| BUN, Day 21 Above |
|
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| BUN, Day 42 Unknown |
|
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| BUN, Day 42 Below |
|
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| BUN, Day 42 Within |
|
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| BUN, Day 42 Above |
|
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| BUN, M6 Unknown |
|
|
| BUN, M6 Below |
|
|
| BUN, M6 Within |
|
|
| BUN, M6 Above |
|
|