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The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluNG Aged Group | Experimental | Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). |
|
| FluNG Fresh Group | Experimental | Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK investigational FluNG vaccine GSK2186877A, aged lot | Biological | Single dose, intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Days 0 and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seropositive Against the 3 Vaccine Strains | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Days 0 and 21 |
| Number of Subjects Seroconverted for the 3 Vaccine Strains |
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Inclusion Criteria:
Exclusion Criteria:
Any confirmed or suspected influenza illness within the last 6 months.
Previous vaccination against influenza with any seasonal vaccine since December 2008.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Acute disease and/or fever at the time of enrolment.
Any medical conditions in which intramuscular injections are contraindicated.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tallinn | 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 |
|---|---|---|---|
| 112662 | 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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Two subjects enrolled in the study did not receive any vaccination, and as such are not accounted for as started.
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| ID | Title | Description |
|---|---|---|
| FG000 | FluNG Aged Group | Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). |
| FG001 | FluNG Fresh Group | Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| GSK investigational FluNG vaccine GSK2186877A, fresh lot | Biological | Single dose, intramuscular injection |
|
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. |
| At Day 21 |
| Seroconversion Factor for the 3 Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Day 21 |
| Number of Subjects Seroprotected for the 3 Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | At Days 0 and 21 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination. | During the 7-day post-vaccination period |
| Duration of Solicited Local and General Symptoms | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced. | During the 7-day post-vaccination period |
| Number of Subjects Reporting 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. | During the 21-day post-vaccination period |
| Number of Subjects Reporting Adverse Events of Specific Interest (AESI) | AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders. | During the 21-day post-vaccination period |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | During the entire study period (up to Day 21) |
| Tartu |
| 50106 |
| Estonia |
| GSK Investigational Site | Bratislava | 811 03 | Slovakia |
| GSK Investigational Site | Bratislava | 814 66 | Slovakia |
| GSK Investigational Site | Bratislava | 841 04 | Slovakia |
| GSK Investigational Site | Veľký Biel | 900 24 | Slovakia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112662 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112662 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112662 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112662 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112662 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112662 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FluNG Aged Group | Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). |
| BG001 | FluNG Fresh Group | Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0 and 21 |
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| Secondary | Number of Subjects Seropositive Against the 3 Vaccine Strains | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point. | Posted | Count of Participants | Participants | At Days 0 and 21 |
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| Secondary | Number of Subjects Seroconverted for the 3 Vaccine Strains | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points. | Posted | Count of Participants | Participants | At Day 21 |
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| Secondary | Seroconversion Factor for the 3 Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points. | Posted | Geometric Mean | 95% Confidence Interval | Fold Increase | At Day 21 |
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| Secondary | Number of Subjects Seroprotected for the 3 Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point. | Posted | Count of Participants | Participants | At Days 0 and 21 |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed. | Posted | Count of Participants | Participants | During the 7-day post-vaccination period |
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| Secondary | Duration of Solicited Local and General Symptoms | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced. | The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only. | Posted | Median | Full Range | Days | During the 7-day post-vaccination period |
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| Secondary | Number of Subjects Reporting 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. | The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects. | Posted | Count of Participants | Participants | During the 21-day post-vaccination period |
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| Secondary | Number of Subjects Reporting Adverse Events of Specific Interest (AESI) | AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders. | The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects. | Posted | Count of Participants | Participants | During the 21-day post-vaccination period |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects. | Posted | Count of Participants | Participants | During the entire study period (up to Day 21) |
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Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
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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 | FluNG Aged Group | Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). | 1 | 362 | 242 | 362 | ||
| EG001 | FluNG Fresh Group | Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). | 1 | 362 | 252 | 362 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at the injection site | General disorders | Systematic Assessment |
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| Redness at the injection site | General disorders | Systematic Assessment |
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| Swelling at the injection site | General disorders | Systematic Assessment |
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| Arthralgia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Gastrointestinal symptoms | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Muscle aches | General disorders | Systematic Assessment |
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| Shivering | General disorders | Systematic Assessment |
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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 |
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| Male |
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| A/Brisbane [Day 21] |
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| A/Uruguay [Day 0] |
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| A/Uruguay [Day 21] |
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| B/Brisbane [Day 0] |
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| B/Brisbane [Day 21] |
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