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The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-Pandemrix-Fluarix Group | Experimental | Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. |
|
| Fluarix-Pandemrix-Placebo Group | Experimental | Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandemrix (GSK investigational influenza GSK2340272A vaccine) | Biological | 2 doses intramuscular injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain | Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09. | At Day 42 |
| Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain | The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity. | At Day 42 |
| Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain | The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. | At Day 42 |
| Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain | Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09. | At Day 42 |
| Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain | The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. | At Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. | Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere influenza vaccine.
Previous administration of a pandemic influenza vaccine.
Administration of any vaccine within 30 days before first vaccination.
Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with the GSK2340272A candidate vaccine.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Presence of an axillary temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
Diagnosed with cancer, or treatment for cancer, within 3 years.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination and during the entire study period.
Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
An acute evolving neurological disorder or history of Guillain-Barré syndrome.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases).
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
History of chronic alcohol consumption and/or drug abuse.
Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Rednitzhembach | Bavaria | 91126 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22885014 | Derived | Peeters M, Regner S, Vaman T, Devaster JM, Rombo L. Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials. Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9. |
| 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 |
|---|---|---|---|
| 113572 | 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 | Placebo-Pandemrix-Fluarix Group | Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. |
| FG001 | Fluarix-Pandemrix-Placebo Group | Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-Pandemrix-Fluarix Group | Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain | Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 42 |
|
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Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
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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 | Placebo-Pandemrix-Fluarix Group | Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment | after Pandemrix administration |
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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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| ID | Term |
|---|---|
| C556153 | pandemrix |
| C510903 | fluarix |
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| Fluarix™ | Biological | 1 dose intramuscular injection |
|
| Placebo | Biological | 1 dose intramuscular injection |
|
| Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | The cut-off was a titer of 1:10 and this titer was considered as seropositivity. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. | At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 |
| Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63). | At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. |
| Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | For the definition of seroconversion factor, please refer to the primary outcome measure. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63). | At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. |
| Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. | Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 |
| Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). | During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix |
| Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius) | During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination | During 21 days (Day 0-20) after each vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period (Day 0-364) |
| Number of Subjects With AEs of Specific Interest | Adverse events of specific interest included auto-immune diseases and other immune mediated disorders. | During the entire study period (Day 0-364) |
| Mainz |
| Rhineland-Palatinate |
| 55116 |
| Germany |
| GSK Investigational Site | Freital | Saxony | 01705 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Hamburg | 22335 | Germany |
| GSK Investigational Site | Hamburg | 22415 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113572 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113572 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113572 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113572 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113572 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113572 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 |
| Fluarix-Pandemrix-Placebo Group |
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Fluarix-Pandemrix-Placebo Group |
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. |
|
|
| Primary | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain | The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Number | subjects | At Day 42 |
|
|
|
| Primary | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain | The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Number | subjects | At Day 42 |
|
|
|
| Primary | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain | Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Mean | 95% Confidence Interval | fold increase | At Day 42 |
|
|
|
| Primary | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain | The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Number | subjects | At Day 42 |
|
|
|
| Secondary | Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 |
|
|
|
| Secondary | Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | The cut-off was a titer of 1:10 and this titer was considered as seropositivity. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Number | subjects | At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 |
|
|
|
| Secondary | Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Number | subjects | At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. |
|
|
|
| Secondary | Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | For the definition of seroconversion factor, please refer to the primary outcome measure. Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Mean | 95% Confidence Interval | fold increase | At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. |
|
|
|
| Secondary | Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40. Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure. Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available. | Posted | Number | subjects | Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 |
|
|
|
| Secondary | Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix | Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). | The analysis was performed on the Total Vaccinated cohort on subjects with available results | Posted | Number | subjects | During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix |
|
|
|
| Secondary | Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix | Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius) | The analysis was performed on the Total Vaccinated cohort on subjects with available results. | Posted | Number | subjects | During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | During 21 days (Day 0-20) after each vaccination |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | During the entire study period (Day 0-364) |
|
|
|
| Secondary | Number of Subjects With AEs of Specific Interest | Adverse events of specific interest included auto-immune diseases and other immune mediated disorders. | The analysis was performed on the Total Vaccinated cohort. | Posted | Number | subjects | During the entire study period (Day 0-364) |
|
|
|
| 11 |
| 72 |
| 59 |
| 72 |
| EG001 | Fluarix-Pandemrix-Placebo Group | Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. | 14 | 73 | 57 | 73 |
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | Non-systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Tachycardia paroxysmal | Cardiac disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Redness | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Swelling | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Pain | General disorders | Systematic Assessment | after Fluarix administration |
|
| Fatigue | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Headache | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Joint pain at other location | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Muscle aches | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Shivering | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Sweating | General disorders | Systematic Assessment | after Pandemrix administration |
|
| Fatigue | General disorders | Systematic Assessment | after Fluarix administration |
|
| Headache | General disorders | Systematic Assessment | after Fluarix administration |
|
| Joint pain at other location | General disorders | Systematic Assessment | after Fluarix administration |
|
| Muscle aches | General disorders | Systematic Assessment | after Fluarix administration |
|
| Shivering | General disorders | Systematic Assessment | after Fluarix administration |
|
| Sweating | General disorders | Systematic Assessment | after Fluarix administration |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 21 A/Cal/7/09 (N=64;67) |
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| Day 63 A/Cal/7/09 (N=63;66) |
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| Month 6 A/Cal/7/09 (N=60;63) |
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| Month 12 A/Cal/7/09 (N=60;64) |
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| Day -21 A/Bri/59/07 (N=64;67) |
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| Day 0 A/Bri/59/07 (N=64;67) |
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| Day 42 A/Bri/59/07 (N=64;67) |
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| Day 63 A/Bri/59/07 (N=63;66) |
|
| Day -21 B/Bri/60/08 (N=64;67) |
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| Day 0 B/Bri/60/08 (N=64;67) |
|
| Day 42 B/Bri/60/08 (N=64;67) |
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| Day 63 B/Bri/60/08 (N=63;66) |
|
| Day -21 A/Uru/716/07 (N=64;67) |
|
| Day 0 A/Uru/716/07 (N=64;67) |
|
| Day 42 A/Uru/716/07 (N=64;67) |
|
| Day 63 A/Uru/716/07 (N=63;66) |
|
| Day 21 A/Cal/7/09 (N=64;67) |
|
| Day 63 A/Cal/7/09 (N=63;66) |
|
| Month 6 A/Cal/7/09 (N=60;63) |
|
| Month 12 A/Cal/7/09 (N=60;64) |
|
| Day -21 A/Bri/59/07 (N=64;67) |
|
| Day 0 A/Bri/59/07 (N=64;67) |
|
| Day 42 A/Bri/59/07 (N=64;67) |
|
| Day 63 A/Bri/59/07 (N=63;66) |
|
| Day -21 B/Bri/60/08 (N=64;67) |
|
| Day 0 B/Bri/60/08 (N=64;67) |
|
| Day 42 B/Bri/60/08 (N=64;67) |
|
| Day 63 B/Bri/60/08 (N=63;66) |
|
| Day -21 A/Uru/716/07 (N=64;67) |
|
| Day 0 A/Uru/716/07 (N=64;67) |
|
| Day 42 A/Uru/716/07 (N=64;67) |
|
| Day 63 A/Uru/716/07 (N=63;66) |
|
| Month 12 A/Cal/7/09 (N=60;64) |
|
| Day 63/Day 0 A/Bri/56/07 (N=63;67) |
|
| Day 63/Day 0 B/Bri/60/08 (N=63;67) |
|
| Day 63/Day 0 A/Uru/716/07 (N=63;67) |
|
| Month 12 A/Cal/7/09 (N=60;64) |
|
| Day 63/Day 0 A/Bri/56/07 (N=63;67) |
|
| Day 63/Day 0 B/Bri/60/08 (N=63;67) |
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| Day 63/Day 0 A/Uru/716/07 (N=63;67) |
|
| Day 21 A/Cal/7/09 (N=64;67) |
|
| Day 63 A/Cal/7/09 (N=63;66) |
|
| Month 6 A/Cal/7/09 (N=60;63) |
|
| Month 12 A/Cal/7/09 (N=60;64) |
|
| Day -21 A/Bri/59/07 (N=64;67) |
|
| Day 0 A/Bri/59/07 (N=64;67) |
|
| Day 42 A/Bri/59/07 (N=64;67) |
|
| Day 63 A/Bri/59/07 (N=63;66) |
|
| Day -21 B/Bri/60/08 (N=64;67) |
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| Day 0 B/Bri/60/08 (N=64;67) |
|
| Day 42 B/Bri/60/08 (N=64;67) |
|
| Day 63 B/Bri/60/08 (N=63;66) |
|
| Day -21 A/Uru/716/07 (N=64;67) |
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| Day 0 A/Uru/716/07 (N=64;67) |
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| Day 42 A/Uru/716/07 (N=64;67) |
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| Day 63 A/Uru/716/07 (N=63;66) |
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| Swelling |
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| Fatigue |
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| Headache |
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| Joint pain at other location |
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| Muscle aches |
|
| Shivering |
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| Sweating |
|
| Temperature |
|
| swelling Day -21 (N=72;72) |
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| pain Day 42 (N=69;71) |
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| redness Day 42 (N=69;71) |
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| swelling Day 42 (N=69;71) |
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| fatigue Day -21 (N=72;72) |
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| headache Day -21 (N=72;72) |
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| joint pain at other location Day -21 (N=72;72) |
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| muscle aches Day -21 (N=72;72) |
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| shivering Day -21 (N=72;72) |
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| sweating Day -21 (N=72;72) |
|
| temperature Day -21 (N=72;72) |
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| fatigue Day 42 (N=69;71) |
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| headache Day 42 (N=69;71) |
|
| joint pain at other location Day 42 (N=69;71) |
|
| muscle aches Day 42 (N=69;71) |
|
| shivering Day 42 (N=69;71) |
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| sweating Day -21 (N=69;71) |
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| temperature Day 42 (N=69;71) |
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| Related |
|