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This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluarix Group | Experimental | Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. |
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| Havrix Group | Active Comparator | Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluarixTM | Biological | One Intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Day 28 data were presented only for the Fluarix Group. Titres were expressed as geometric mean antibody titre. | At Day 0 and Day 28 |
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data was presented only for the Fluarix Group. | At Day 0 and Day 28 |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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. Day 28 data were presented for the Fluarix Group only. | At Day 28 |
| Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only. | At Day 0 and Day 28 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. Titres were expressed as geometric mean antibody titres (GMTs). | At Day 0 and Day 28 |
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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 | Tampere | 33100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26069949 | Derived | Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709. |
| 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 |
|---|---|---|---|
| 114452 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluarix Group | Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. |
| FG001 | Havrix Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Up to Day 28 |
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| HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old) |
| Biological |
Two Intramuscular injections |
|
| At Day 28 |
| Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. Titres were expressed as geometric mean antibody titres (GMTs). | At Day 0 and at Month 6 |
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data were presented for the Fluarix Group only. | At Day 0 and Day 28 |
| Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | At Day 0 and at Month 6 |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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. Day 28 data were presented for the Fluarix Group only. | At Day 28 |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | At Month 6 |
| Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only. | At Day 0 and Day 28 |
| Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | At Day 0 and Month 6 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only. | At Day 28 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | At Month 6 |
| Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. Titres were expressed as geometric mean antibody titres (GMTs). | At Day 0 and at Day 28 |
| Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. Titres were expressed as geometric mean antibody titres (GMTs). | At Day 0 and at Month 6 |
| Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains. | A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination. Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. | At Day 28 |
| Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains. | A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination. Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | At Month 6 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres. | Within 7 days (Day 0 - Day 6) after vaccination |
| Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius). Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius. | Within 7 days (Day 0 - Day 6) after vaccination |
| Number of Days With Any Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Inter-quartile range assessed was the 25th percentile and the 75th percentile. | Within 7 days (Day 0 - Day 6) after vaccination |
| Number of Days With Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain and swelling. Grade 3 redness/swelling = redness/swelling above 50 millimetres. Inter-quartile range assessed was the 25th percentile and the 75th percentile. | Within 7 days (Day 0 - Day 6) after vaccination |
| Number of Days With Any Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius). Inter-quartile range assessed was the 25th percentile and the 75th percentile. | Within 7 days (Day 0 - Day 6) after vaccination |
| Number of Days With Grade 3 Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia. Grade 3 symptom = general symptom that prevented normal activity. Inter-quartile range assessed was the 25th percentile and the 75th percentile. | Within 7 days (Day 0 - Day 6) after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited adverse event is any adverse event (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. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. | Within 28 days (Day 0 - Day 27) after vaccination |
| Number of Subjects Reporting Medically-attended Events (MAEs). | For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason. | Within the 28-day (Days 0-27) post-vaccination period |
| Number of Subjects Reporting Medically-attended Events (MAEs). | For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason. | During the entire study period (Up to Month 6) |
| Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs). | Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. | During the entire study period (Up to Month 6) |
| Number of Subjects Reporting Adverse Events of Special Interest. | Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis. | During the entire study period (Up to Month 6) |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | Within the 28-day (Days 0-27) post-vaccination period |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | During the entire study period (Up to Month 6) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114452 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114452 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114452 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114452 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114452 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
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| NOT COMPLETED |
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| Up to Month 6 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluarix Group | Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. |
| BG001 | Havrix Group | Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. |
| 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 | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Day 28 data were presented only for the Fluarix Group. Titres were expressed as geometric mean antibody titre. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Titres | At Day 0 and Day 28 |
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| Primary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data was presented only for the Fluarix Group. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 0 and Day 28 |
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| Primary | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 28 |
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| Primary | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 0 and Day 28 |
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| Primary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. | Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 28 |
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| Secondary | Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. Titres were expressed as geometric mean antibody titres (GMTs). | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Titres | At Day 0 and Day 28 |
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| Secondary | Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. Titres were expressed as geometric mean antibody titres (GMTs). | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Geometric Mean | 95% Confidence Interval | Titres | At Day 0 and at Month 6 |
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| Secondary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 0 and Day 28 |
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| Secondary | Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Number | Subjects | At Day 0 and at Month 6 |
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| Secondary | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 28 |
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| Secondary | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Number | Subjects | At Month 6 |
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| Secondary | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 0 and Day 28 |
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| Secondary | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Number | Subjects | At Day 0 and Month 6 |
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| Secondary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 28 |
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| Secondary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Month 6 |
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| Secondary | Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. Titres were expressed as geometric mean antibody titres (GMTs). | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Geometric Mean | 95% Confidence Interval | titre | At Day 0 and at Day 28 |
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| Secondary | Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains. | Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. Titres were expressed as geometric mean antibody titres (GMTs). | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Geometric Mean | 95% Confidence Interval | titre | At Day 0 and at Month 6 |
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| Secondary | Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains. | A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination. Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. | The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose. | Posted | Number | Subjects | At Day 28 |
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| Secondary | Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains. | A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination. Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. | Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6. | Posted | Number | Subjects | 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 = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | Within 7 days (Day 0 - Day 6) after vaccination |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius). Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | Within 7 days (Day 0 - Day 6) after vaccination |
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| Secondary | Number of Days With Any Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Inter-quartile range assessed was the 25th percentile and the 75th percentile. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | Within 7 days (Day 0 - Day 6) after vaccination |
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| Secondary | Number of Days With Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain and swelling. Grade 3 redness/swelling = redness/swelling above 50 millimetres. Inter-quartile range assessed was the 25th percentile and the 75th percentile. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | Within 7 days (Day 0 - Day 6) after vaccination |
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| Secondary | Number of Days With Any Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius). Inter-quartile range assessed was the 25th percentile and the 75th percentile. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | Within 7 days (Day 0 - Day 6) after vaccination |
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| Secondary | Number of Days With Grade 3 Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia. Grade 3 symptom = general symptom that prevented normal activity. Inter-quartile range assessed was the 25th percentile and the 75th percentile. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Median | Inter-Quartile Range | Days | Within 7 days (Day 0 - Day 6) after vaccination |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited adverse event is any adverse event (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. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | Within 28 days (Day 0 - Day 27) after vaccination |
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| Secondary | Number of Subjects Reporting Medically-attended Events (MAEs). | For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | Within the 28-day (Days 0-27) post-vaccination period |
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| Secondary | Number of Subjects Reporting Medically-attended Events (MAEs). | For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Up to Month 6) |
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| Secondary | Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs). | Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Up to Month 6) |
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| Secondary | Number of Subjects Reporting Adverse Events of Special Interest. | Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Up to Month 6) |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | Within the 28-day (Days 0-27) post-vaccination period |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The Total Vaccinated cohort included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Up to Month 6) |
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Serious adverse events were assessed up to Day 28 and during the entire study period, up to Month 6. Systematically and non-systematically assessed frequent adverse events were assessed during the 7 day and 28 day post-vaccination period 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 | Fluarix Group | Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. | 1 | 38 | 37 | 38 | ||
| EG001 | Havrix Group | Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. | 0 | 39 | 34 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tonsillitis | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Arthralgia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Gastrointestinal symptoms | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Myalgia | General disorders | Systematic Assessment |
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| Shivering | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Temperature | General disorders | 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 |
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