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| ID | Type | Description | Link |
|---|---|---|---|
| 107191 | Other Identifier | GSK |
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The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events.
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-AS03 Group | Experimental | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK1247446A Group | Experimental | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Fluarix Group | Active Comparator | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candidate Influenza Vaccine GSK1247446A - 2 different formulations | Biological | Single dose, Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10. | At Days 0 and 21 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10. | At Day 180 post-vaccination. |
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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 | Helsinki | 00100 | Finland | |||
| 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 |
|---|---|---|---|
| 107022 | Clinical Study Report | 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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A total of 1220 subjects were enrolled in the study. Study duration was of approximately 6 months (180 days) for all subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1247446A-AS03 Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | GSK1247446A Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG002 | Fluarix Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1247446A-AS03 Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | GSK1247446A Group |
| 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 | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10. | The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Days 0 and 21 post-vaccination |
|
SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period.
Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
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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-AS03 Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| FluarixTM | Biological | Single dose, Intramuscular injection |
|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| During the 7-day (Days 0-6) follow-up period after vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 7-day (Days 0-6) follow up period after vaccination |
| Number of Subjects With Unsolicited Adverse Events (AEs). | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | During the 30-day (Days 0-29) follow-up period after vaccination |
| 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 or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination. | During the entire study period (Day 0 to Day 180) |
| Helsinki |
| 00930 |
| Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Kotka | 48100 | Finland |
| GSK Investigational Site | Lahti | 15140 | Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Pori | 28120 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Vantaa | 01300 | Finland |
| GSK Investigational Site | Vantaa | 01600 | Finland |
| 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 | Thessaloniki | 54642 | Greece |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107022 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107022 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107022 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107022 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
| Other |
|
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Fluarix Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | GSK1247446A Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG002 | Fluarix Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10. | The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 180 post-vaccination. |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed. | Posted | Number | Subjects | During the 7-day (Days 0-6) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed. | Posted | Number | Subjects | During the 7-day (Days 0-6) follow up period after vaccination |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs). | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects. | Posted | Number | Subjects | During the 30-day (Days 0-29) follow-up period after vaccination |
|
|
|
| Secondary | 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 or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination. | The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During the entire study period (Day 0 to Day 180) |
|
|
|
| 8 |
| 407 |
| 302 |
| 407 |
| EG001 | GSK1247446A Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 13 | 406 | 143 | 406 |
| EG002 | Fluarix Group | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 13 | 407 | 181 | 407 |
|
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Grand mal convulsion | Nervous system disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Injection site erythema | General disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Pyrexia | General disorders | Non-systematic Assessment | SAE reported from Day 0 to Day 30. |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Brain stem thrombosis | Nervous system disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Diverticulitis | Infections and infestations | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Drowning | General disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Extrasystoles | Cardiac disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Irritable bowel syndrome | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Peptic ulcer | Gastrointestinal disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Pyelonephritis | Infections and infestations | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Skull fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Subarachnoid haemorrhage | Nervous system disorders | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Uterine neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported from Day 30 to Day 180. |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Muscle aches | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
| Ecchymosis | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | 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 |
|
| B/Malaysia at Day180 |
|
| Title | Measurements |
|---|---|
|
| Any Ecchymosis |
|
| Ecchymosis > 50mm |
|
| Any Redness |
|
| Redness > 50mm |
|
| Any Swelling |
|
| Swelling > 50mm |
|
| Title | Measurements |
|---|---|
|
| Related Arthralgia |
|
| Any Fatigue |
|
| Grade 3 Fatigue |
|
| Related Fatigue |
|
| Fever (oral) ≥37.5°C |
|
| Fever (oral) ≥39.0°C |
|
| Related Fever |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Muscle aches |
|
| Grade 3 Muscle aches |
|
| Related Muscle aches |
|
| Any Shivering |
|
| Grade 3 Shivering |
|
| Related Shivering |
|
|
| Subjects with related AEs |
|
|