Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002783-10 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1247446A Group | Experimental | Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. |
|
| Fluarix Group | Active Comparator | Subjects aged between 18 and 60 years, having previously received one dose of Fluarixâ„¢ vaccine during the primary study NCT00374842, received one dose of Fluarixâ„¢ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltiod region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine GSK1247446A | Biological | Single dose, Intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination. | During a 7-day (Days 0-6) follow-up period after re-vaccination |
| 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, myalgia, nausea 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 a 7-day (Days 0-6) follow-up after re-vaccination |
| 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 causally related to the study vaccination. | During a 30-day (Days 0-29) follow-up period after re-vaccination |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Serious adverse events (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. Related = SAE assessed by the investigator as causally related to the study vaccination. |
| 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10. | At Days 0 and 21 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
Not provided
| 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 |
|---|---|---|---|
| 110674 | 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.
Not provided
Not provided
Not provided
Not provided
Subjects were allocated to study groups based on their vaccination course in the NCT00374842 primary study, so as to receive a re-vaccination dose of the vaccine previously administered.
Subjects enrolled and vaccinated in this NCT00545025 follow-up previously participated in the NCT00374842 study, wherein they were vaccinated with either the GSK1247446A or Fluarixâ„¢ vaccines.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK1247446A Group | Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. |
| FG001 | Fluarix Group | Subjects aged between 18 and 60 years, having previously received one dose of Fluarixâ„¢ vaccine during the primary study NCT00374842, received one dose of Fluarixâ„¢ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK1247446A Group | Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. |
| 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 | 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 everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During a 7-day (Days 0-6) follow-up period after re-vaccination |
|
Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK1247446A Group | Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluarixâ„¢ |
| Biological |
Single dose, Intramuscular injection |
|
| During the entire study period (Days 0-30) |
| 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
| 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). | At Day 0 and 21 |
| Seroconversion Factor for 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). | At Day 21 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110674 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110674 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110674 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110674 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110674 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 | Fluarix Group | Subjects aged between 18 and 60 years, having previously received one dose of Fluarixâ„¢ vaccine during the primary study NCT00374842, received one dose of Fluarixâ„¢ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Fluarix Group | Subjects aged between 18 and 60 years, having previously received one dose of Fluarixâ„¢ vaccine during the primary study NCT00374842, received one dose of Fluarixâ„¢ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. |
|
|
| 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, myalgia, nausea 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. | Posted | Number | Subjects | During a 7-day (Days 0-6) follow-up after re-vaccination |
|
|
|
| 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 causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | Subjects | During a 30-day (Days 0-29) follow-up period after re-vaccination |
|
|
|
| Primary | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Serious adverse events (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. Related = 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 | Subjects | During the entire study period (Days 0-30) |
|
|
|
| Secondary | 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10. | The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0 and 21 |
|
|
|
| Secondary | 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). | The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). | The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination. | Posted | Number | Subjects | At Day 0 and 21 |
|
|
|
| Secondary | Seroconversion Factor for 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). | The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
|
|
|
| 0 |
| 160 |
| 0 |
| 160 |
| 143 |
| 160 |
| EG001 | Fluarix Group | Subjects aged between 18 and 60 years, having previously received one dose of Fluarixâ„¢ vaccine during the primary study NCT00374842, received one dose of Fluarixâ„¢ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. | 0 | 83 | 1 | 83 | 57 | 83 |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment | Headache was reported as an unsolicited adverse event (AE). |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Fever | General disorders | MedDRA | Systematic Assessment | Fever was defined as oral temperature ≥ 37.5 degrees Celsius (°C) |
|
| Headache | General disorders | MedDRA | Systematic Assessment |
|
| Myalgia | General disorders | MedDRA | Systematic Assessment |
|
| Nausea | General disorders | MedDRA | Systematic Assessment |
|
| Shivering | General disorders | MedDRA | Systematic Assessment |
|
| Ecchymosis | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Redness | General disorders | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | 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 |
| Related Arthralgia |
|
| Any Fatigue |
|
| Grade 3 Fatigue |
|
| Related Fatigue |
|
| Fever ≥37.5°C |
|
| Fever >39.0°C |
|
| Related Fever |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Myalgia |
|
| Grade 3 Myalgia |
|
| Related Myalgia |
|
| Any Nausea |
|
| Grade 3 Nausea |
|
| Related Nausea |
|
| Any Shivering |
|
| Grade 3 Shivering |
|
| Related Shivering |
|
| Related AEs |
|
| A/WIS, Day 0 [N=158, 82] |
|
| A/WIS, Day 21 [N=159, 82] |
|
| B/MAL, Day 0 [N=158, 82] |
|
| B/MAL, Day 21 [N=159, 82] |
|
| B/MAL |
|
| A/WIS, Day 0 [N=158, 82] |
|
| A/WIS, Day 21 [N=159, 82] |
|
| B/MAL, Day 0 [N=158, 82] |
|
| B/MAL, Day 21 [N=159, 82] |
|
| B/MAL |
|