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The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1247446A Formulation 1 Group | Experimental | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK1247446A Formulation 2 Group | Experimental | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Fluarix Group | Active Comparator | Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix™ | Biological | GlaxoSmithKline Biologicals' licensed influenza vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU. | At Day 0 and at Day 21. |
| Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen). | At Day 0 and at Day 21. |
| Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer. | At Day 21. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study 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 | Wilrijk | 2610 | Belgium |
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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 |
|---|---|---|---|
| 108656 | Individual Participant Data Set | 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 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1247446A Formulation 1 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | GSK1247446A Formulation 2 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| FG002 | Fluarix Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ 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 Formulation 1 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 |
| 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 of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | HIU | At Day 0 and at Day 21. |
|
Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
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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 Formulation 1 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural nausea | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | General disorders | MedDRA | 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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| ID | Term |
|---|---|
| C510903 | fluarix |
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| GSK1247446A |
| Biological |
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine |
|
| Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]). | At Day 21. |
| Within the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C. | Within the 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination. | Within the 30-day follow-up period (Days 0-29) 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination. | From study start to study end, from Day 0 to Day 30 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108656 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108656 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108656 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108656 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GSK1247446A Formulation 2 Group |
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Fluarix Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ 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 |
|
| Description |
|---|
| OG000 | GSK1247446A Formulation 1 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm |
| OG001 | GSK1247446A Formulation 2 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| OG002 | Fluarix Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Primary | Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. | A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Number | Subject | At Day 0 and at Day 21. |
|
|
|
| Primary | Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Number | Subject | At Day 21. |
|
|
|
| Primary | Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. | Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]). | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21. |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subject | Within the 7-day follow-up period (Days 0-6) after vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subject | Within the 7-day follow-up period (Days 0-6) after vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subject | Within the 30-day follow-up period (Days 0-29) 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subject | From study start to study end, from Day 0 to Day 30 |
|
|
|
| 1 |
| 100 |
| 98 |
| 100 |
| EG001 | GSK1247446A Formulation 2 Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 0 | 100 | 95 | 100 |
| EG002 | Fluarix Group | Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm | 0 | 100 | 81 | 100 |
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Redness | General disorders | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Headache | General disorders | MedDRA | Systematic Assessment |
|
| Muscle aches | General disorders | MedDRA | Systematic Assessment |
|
| Shivering | General disorders | MedDRA | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | 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 |
| Title | Measurements |
|---|---|
|
| A/WIS, Day 0 |
|
| A/WIS, Day 21 |
|
| B/MAL, Day 0 |
|
| B/MAL, Day 21 |
|
| Title | Measurements |
|---|---|
|
| B/MAL, Day 21 |
|
|
| B/MAL, Day 21 |
|
|
| Any pain |
|
| Grade 3 pain |
|
| Any redness |
|
| Grade 3 redness (> 50 mm) |
|
| Any swelling |
|
| Grade 3 swelling (> 50 mm) |
|
| Title | Measurements |
|---|---|
|
| Related arthralgia |
|
| Any fatigue |
|
| Grade 3 fatigue |
|
| Related fatigue |
|
| Axillary fever (>= 37.5°C) |
|
| Grade 3 axillary fever (> 39.0°C) |
|
| Related axillary fever (>= 37.5°C) |
|
| Any headache |
|
| Grade 3 headache |
|
| Related headache |
|
| Any muscle aches |
|
| Grade 3 muscle aches |
|
| Related muscle aches |
|
| Any shivering |
|
| Grade 3 shivering |
|
| Related shivering |
|
|
| Subject(s) with related unsolicited AE(s) |
|
|