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Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.
Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Old Bulk | Experimental | This group receives a full dose of Fluviral made from aged bulk material |
|
| New Bulk | Active Comparator | This group receives a full dose of Fluviral made from new material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluviral | Biological | One dose, Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Anti-H3 and B Strains | GMTs for H1 strain is addressed as a secondary endpoint | At Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains | The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures) | At Days 0 and 21 |
| Number of Participants Who Seroconverted. |
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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 | Coquitlam | British Columbia | V3K 3P4 | Canada | ||
| 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 |
|---|---|---|---|
| 111258 | Annotated Case Report Form | 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 | Old Bulk | This group received a full dose of Fluviral made from aged bulk material |
| FG001 | New Bulk | This group received a full dose of Fluviral made from new material |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Old Bulk | This group received a full dose of Fluviral made from aged bulk material |
| BG001 | New Bulk | This group received a full dose of Fluviral made from new material |
| 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 Anti-H3 and B Strains | GMTs for H1 strain is addressed as a secondary endpoint | Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 21 |
|
Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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 | Old Bulk | This group received a full dose of Fluviral made from aged bulk material |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-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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The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21. |
| At Day 21. |
| Number of Seroprotected Participants. | The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection. | At Days 0 and 21 |
| Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1 | Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table. | At Day 21 compared to Day 0 |
| The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B | The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor." | At Day 21 compared to Day 0 |
| Number of Participants Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | During the 4-day follow up period following vaccination. |
| Number of Participants Reporting Solicited General Symptoms | Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face | During the 4-day period following each vaccination. |
| Number of Participants Reporting Unsolicited Adverse Events (AE). | An AE is 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. | During the 21-day period following each vaccination. |
| Number of Participants Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Within 21 days after vaccination |
| Bay Roberts |
| Newfoundland and Labrador |
| A0A 1G0 |
| Canada |
| GSK Investigational Site | Toronto | Ontario | M1L 4S4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Gatineau | Quebec | J8Y 6S8 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 4J6 | Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111258 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111258 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111258 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111258 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111258 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111258 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains | The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures) | Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0 and 21 |
|
|
|
| Secondary | Number of Participants Who Seroconverted. | The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21. | Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria. | Posted | Number | participants | At Day 21. |
|
|
|
| Secondary | Number of Seroprotected Participants. | The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection. | Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria. | Posted | Number | participants | At Days 0 and 21 |
|
|
|
| Secondary | Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1 | Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table. | Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria. | Posted | Number | Factor | At Day 21 compared to Day 0 |
|
|
|
| Secondary | The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B | The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor." | Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria. | Posted | Number | Factor | At Day 21 compared to Day 0 |
|
|
|
| Secondary | Number of Participants Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | Analysis was performed on the Total Vaccinated cohort. | Posted | Number | participants | During the 4-day follow up period following vaccination. |
|
|
|
| Secondary | Number of Participants Reporting Solicited General Symptoms | Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face | Analysis was performed on the Total Vaccinated cohort. | Posted | Number | participants | During the 4-day period following each vaccination. |
|
|
|
| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AE). | An AE is 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. | The analysis was performed on the Total Vaccinated Cohort. | Posted | Number | participants | During the 21-day period following each vaccination. |
|
|
|
| Secondary | Number of Participants Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Posted | Number | participants | Within 21 days after vaccination |
|
|
|
| 0 |
| 500 |
| 0 |
| 500 |
| 271 |
| 500 |
| EG001 | New Bulk | This group received a full dose of Fluviral made from new material | 0 | 500 | 4 | 500 | 290 | 500 |
| Bipolar disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Bronchospasm | General disorders | Systematic Assessment |
|
| 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 |
|
| Red eyes | General disorders | Systematic Assessment |
|
| Sore throat | 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 |
| Anti-H3N2 antibody GMT at Day 0 (n=297, 292) |
|
| Anti-B antibody GMT at Day 0 (n=297, 292) |
|
| Anti-B |
|
| Anti-H3N2 at Day 0 (n=297, 292) |
|
| Anti-H3N2 at Day 21 (n=298, 291) |
|
| Anti-B antibody GMT at Day 0 (n=297, 292) |
|
| Anti-B antibody GMT at Day21 (n=298, 291) |
|
| Swelling |
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| Cough |
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| Fatigue |
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| Axillary fever >= 37.5° Celsius (C) |
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| Headache |
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| Joint pain at other location |
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| Muscle aches |
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| Red eyes |
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| Sore throat |
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| Swelling of the face |
|