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This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluviral Adult Group | Experimental | Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
|
| Fluviral Elderly Group | Experimental | Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluviral® | Biological | Intramuscular injection, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies | Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | At Day 0 |
| GMTs of HI Antibodies | Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | At Day 21 after vaccination |
| Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value | The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | At Day 0 |
| Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value | The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | At Day 21 after vaccination |
| Number of Seroconverted Subjects | A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | At Day 21 after vaccination |
| Seroconversion Factors |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Any Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade | During a 4-day (Day 0-3) follow-up period after vaccination |
| Number of Subjects Reporting Grade 3 Solicited Local Symptoms |
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Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject
Male and female adults, 18 to 60 years of age and over 60 years of age.
Satisfactory baseline medical assessment by history and physical examination
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.
• Any confirmed or suspected immunosuppressive condition including: History of human immunodeficiency virus (HIV) infection, Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
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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 |
|---|---|---|---|
| 110586 | Dataset Specification | 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 | Fluviral Adult Group | Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
| FG001 | Fluviral Elderly Group | Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) 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 | Fluviral Adult Group | Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
| BG001 | Fluviral Elderly 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 | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies | Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 0 |
|
Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events were collected during the 21-day (Day 0-20) post-vaccination period.
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.
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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 | Fluviral Adult Group | Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | 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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
| At Day 21 after vaccination |
| Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value | The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | At Day 21 after vaccination |
Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm |
| During a 4-day (Day 0-3) follow-up period after vaccination |
| Number of Subjects Reporting Any Solicited General Symptoms | Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius. | During a 4-day (Day 0-3) follow-up period after vaccination |
| Number of Subjects Reporting Grade 3 Solicited General Symptoms | Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius | During a 4-day (Day 0-3) follow-up period after vaccination |
| Number of Subjects Reporting Related Solicited General Symptoms | Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine | During a 4-day (Day 0-3) follow-up period after vaccination |
| Number of Subjects Reporting 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 = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. | During a 21-day (Day 0-20) follow-up period after vaccination |
| Number of Subjects With Serious Adverse Events | SAEs assessed include medical occurrences that result in death, is 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. | From the beginning up to the end of the study (Day 0 - Day 21) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110586 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110586 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110586 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110586 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110586 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110586 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Fluviral Elderly Group |
Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
|
|
| Primary | GMTs of HI Antibodies | Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 21 after vaccination |
|
|
|
| Primary | Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value | The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Number | subjects | At Day 0 |
|
|
|
| Primary | Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value | The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Number | subjects | At Day 21 after vaccination |
|
|
|
| Primary | Number of Seroconverted Subjects | A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Number | subjects | At Day 21 after vaccination |
|
|
|
| Primary | Seroconversion Factors | Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Mean | 95% Confidence Interval | ratio | At Day 21 after vaccination |
|
|
|
| Primary | Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value | The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane. | Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination. | Posted | Number | subjects | At Day 21 after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade | Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available. | Posted | Number | subjects | During a 4-day (Day 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm | Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available. | Posted | Number | subjects | During a 4-day (Day 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any Solicited General Symptoms | Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius. | Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available. | Posted | Number | subjects | During a 4-day (Day 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Grade 3 Solicited General Symptoms | Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius | Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available. | Posted | Number | subjects | During a 4-day (Day 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Related Solicited General Symptoms | Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine | Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available. | Posted | Number | subjects | During a 4-day (Day 0-3) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting 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 = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. | Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available. | Posted | Number | subjects | During a 21-day (Day 0-20) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events | SAEs assessed include medical occurrences that result in death, is 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. | Posted | Number | subjects | From the beginning up to the end of the study (Day 0 - Day 21) |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 34 |
| 55 |
| EG001 | Fluviral Elderly Group | Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm | 0 | 55 | 0 | 55 | 16 | 55 |
| chills | General disorders | Systematic Assessment |
|
| Cough | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Joint pain at other location | General disorders | Systematic Assessment |
|
| Muscle aches | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 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 |
| B/Brisbane |
|
| B/Brisbane |
|
| B/Brisbane |
|
| B/Brisbane |
|
| B/Brisbane |
|
| A/Uruguay |
|
|
| B/Brisbane |
|
|
| Swelling |
|
| Swelling |
|
| Cough |
|
| Fatigue |
|
| Headache |
|
| Joint pain at other location |
|
| Muscle aches |
|
| Red eyes |
|
| Sore throat |
|
| Swelling of the face |
|
| Temperature |
|
| Cough |
|
| Fatigue |
|
| Headache |
|
| Joint pain at other location |
|
| Muscle aches |
|
| Red eyes |
|
| Sore throat |
|
| Swelling of the face |
|
| Temperature |
|
| Cough |
|
| Fatigue |
|
| Headache |
|
| Joint pain at other location |
|
| Muscle aches |
|
| Red eyes |
|
| Sore throat |
|
| Swelling of the face |
|
| Temperature |
|
| Related |
|