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| ID | Type | Description | Link |
|---|---|---|---|
| 107214 | Other Identifier | GSK |
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The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarixâ„¢ administered intramuscularly in elderly aged 60 years old and above.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Experimental | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| GSK1247446A Lot 2 Group | Experimental | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| GSK1247446A Lot 3 Group | Experimental | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| GSK1247446A Pooled Group | Experimental | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candidate Influenza Vaccine GSK1247446A - 3 different formulations | Biological | Single dose, Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | At Days 0 and 21 |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | At Day 21 |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | At Days 0 and 21 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | At Day 21 |
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. |
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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 | Tartu | 50417 | Estonia | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107192 | 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 | GSK1247446A Lot 1 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| FG001 | GSK1247446A Lot 2 Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluarix Group | Active Comparator | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| Fluarix TM | Biological | Single dose, Intramuscular injection |
|
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination. |
| During the 7-day (Days 0-6) post vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination. | During the 7-day (Days 0-6) post vaccination period |
| Number of Subjects With New Onset of Chronic Diseases (NOCDs). | NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs. | From Day 0 to Day 180 |
| Number of Subjects With Medically Significant Conditions (MSCs). | MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs. | From Day 0 to Day 180 |
| 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 activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs. | During the 30-day (Days 0-29) post-vaccination period |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination. | During the entire study period (Days 0-180) |
| Caen |
| 14052 |
| France |
| GSK Investigational Site | Gières | 38610 | France |
| GSK Investigational Site | Lagord | 17140 | France |
| GSK Investigational Site | Lille | 59019 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Poitiers | 86000 | France |
| GSK Investigational Site | Rouen | 76100 | France |
| GSK Investigational Site | Toulouse | 31300 | France |
| GSK Investigational Site | Haag | Bavaria | 83527 | Germany |
| GSK Investigational Site | Höhenkirchen-Siegertsbrunn | Bavaria | 85635 | Germany |
| GSK Investigational Site | Marktl | Bavaria | 84533 | Germany |
| GSK Investigational Site | Oberaudorf | Bavaria | 83080 | Germany |
| GSK Investigational Site | Ketzin | Brandenburg | 14669 | Germany |
| GSK Investigational Site | Koenigslutter | Lower Saxony | 38154 | Germany |
| GSK Investigational Site | Tostedt | Lower Saxony | 21255 | Germany |
| GSK Investigational Site | Delitzsch | Saxony | 04509 | Germany |
| GSK Investigational Site | Freital | Saxony | 01705 | Germany |
| GSK Investigational Site | Kamenz | Saxony | 01917 | Germany |
| GSK Investigational Site | Pirna | Saxony | 01796 | Germany |
| GSK Investigational Site | Weißenberg | Saxony | 02627 | Germany |
| GSK Investigational Site | Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | 24576 | Germany |
| GSK Investigational Site | Athens | 11527 | Greece |
| GSK Investigational Site | Goudi / Athens | 115 27 | Greece |
| GSK Investigational Site | Haidari | 124 62 | Greece |
| GSK Investigational Site | Marousi | 151 26 | Greece |
| GSK Investigational Site | Nikaia Piraeus | 184 54 | Greece |
| GSK Investigational Site | Orestiáda | 682 00 | Greece |
| GSK Investigational Site | Papagos/Athens | 15669 | Greece |
| GSK Investigational Site | Thessaloniki | 54642 | Greece |
| GSK Investigational Site | Elverum | 2408 | Norway |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Paradis | 5231 | Norway |
| GSK Investigational Site | Stavanger | 4010 | Norway |
| GSK Investigational Site | Kazan' | 420015 | Russia |
| GSK Investigational Site | Saratov | 410018 | Russia |
| GSK Investigational Site | Yekaterinburg | 620078 | Russia |
| GSK Investigational Site | Reading | Berkshire | RG2 7AG | United Kingdom |
| GSK Investigational Site | Cardiff | Glamorgan | CF14 5GJ | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G81 4SA | United Kingdom |
| GSK Investigational Site | Buckshaw Village, Chorley | Lancashire | PR7 7NA | United Kingdom |
| GSK Investigational Site | Edgbaston, Birmingham | B15 2SQ | United Kingdom |
| GSK Investigational Site | Manchester | M15 6SX | United Kingdom |
| GSK Investigational Site | Waterloo, Liverpool | L22 0LG | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107192 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107192 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107192 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107192 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| FG002 | GSK1247446A Lot 3 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| FG003 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1247446A Lot 1 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG001 | GSK1247446A Lot 2 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG002 | GSK1247446A Lot 3 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG003 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Days 0 and 21 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Number | subjects | At Day 21 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Number | subjects | At Days 0 and 21 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | At Day 21 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed . | Posted | Number | subjects | During the 7-day (Days 0-6) post vaccination period |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed . | Posted | Number | subjects | During the 7-day (Days 0-6) post vaccination period |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | From Day 0 to Day 180 |
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| Primary | Number of Subjects With Medically Significant Conditions (MSCs). | MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | From Day 0 to Day 180 |
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| Primary | 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 activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the 30-day (Days 0-29) post-vaccination period |
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| Primary | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the entire study period (Days 0-180) |
|
SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after vaccination, Unsolicited AE(s): during the 30-day follow-up period (Days 0 to 29) after vaccination.
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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 | GSK1247446A Lot 1 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 30 | 850 | 653 | 850 | ||
| EG001 | GSK1247446A Lot 2 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 24 | 850 | 636 | 850 | ||
| EG002 | GSK1247446A Lot 3 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 23 | 854 | 634 | 854 | ||
| EG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. | 77 | 2,554 | 1,923 | 2,554 | ||
| EG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. | 21 | 570 | 321 | 570 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Abdominal pain | General disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Cardiac valve disease | Cardiac disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Oesophageal stenosis | Gastrointestinal disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Retinal artery embolism | Eye disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Retinal detachment | Eye disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Angina pectoris | Cardiac disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Hand fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Ileus | Gastrointestinal disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | During the 30-day (Days 0 to 29) post vaccination period. |
| |
| Syncope | Nervous system disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Angina pectoris | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Chest pain | General disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Circulatory collapse | Vascular disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Colonic polyp | Gastrointestinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Aortic stenosis | Vascular disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Cardiovascular disorder | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Cholecystitis infective | Infections and infestations | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Completed suicide | Psychiatric disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Diverticulitis | Infections and infestations | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Forearm fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| General physical health deterioration | General disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Iliac artery stenosis | Vascular disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Mixed connective tissue disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Nephrotic syndrome | Renal and urinary disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Peripheral vascular disorder | Vascular disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Stress | Psychiatric disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Tachyarrhythmia | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Tachycardia paroxysmal | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Trigeminal neuralgia | Nervous system disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Acute coronary syndrome | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Aortic aneurysm | Vascular disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Arrhythmia | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Gallstone ileus | Gastrointestinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Hypertension | Vascular disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Pyrexia | General disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Small intestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Uterine polyp | Reproductive system and breast disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Cardiac failure | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Oedema | General disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Hepatorenal failure | Hepatobiliary disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Diabetic gangrene | Infections and infestations | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
| |
| Thrombotic stroke | Nervous system disorders | Non-systematic Assessment | During the post vaccination period between Days 30 and 180. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Muscle aches | General disorders | Systematic Assessment |
| ||
| Shivering | General disorders | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| A/New Caledonia, Day 21 [N=492;488;492;1472;106] |
|
| A/New York, Day 0 [N=494;494;499;1487;106] |
|
| A/New York, Day 21 [N=492;488;492;1472;106] |
|
| B/Malaysia, Day 0 [N=494;494;499;1487;106] |
|
| B/Malaysia, Day 21 [N=492;488;492;1472;106] |
|
| OG002 |
| GSK1247446A Lot 3 Group |
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG002 | GSK1247446A Lot 3 Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK1247446A Lot 3 Group |
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK1247446A Lot 3 Group |
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK1247446A Lot 3 Group |
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
| OG003 | GSK1247446A Pooled Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | Fluarix Group | Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|