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This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean subjects. A second group of subjects will receive FluarixTM vaccine as control.
Initially, 124 subjects were planned to be enrolled according to a 1:1 randomisation ratio. However, by mistake, the randomisation application was set up consistent with the vaccine supply ratio (2:1) rather than the treatment group randomization ratio (1:1). Subsequently, the protocol was amended to adjust the sample size and randomisation ratio for the study.
The study will enrol 126 subjects randomised 2:1. 84 subjects will receive Prepandrix™ and 42 subjects will receive Fluarix™.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prepandrix Group | Experimental | Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21). |
|
| Fluarix Group | Active Comparator | Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prepandrix™ | Biological | 2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | At Day 42 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). | At Day 42 |
| Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. | At Day 42 |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | Antibody titers were expressed as Geometric mean titers (GMTs). | At Day 0 and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | Antibody titers were expressed as Geometric mean titers (GMTs). | At Day 21 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. |
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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 | Guro Gu | 152703 | South Korea | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25910919 | Derived | Izurieta P, Kim WJ, Wie SH, Lee J, Lee JS, Drame M, Vaughn DW, Schuind A. Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: a phase IV, randomized, open-label, controlled study. Vaccine. 2015 Jun 4;33(24):2800-7. doi: 10.1016/j.vaccine.2015.04.027. Epub 2015 Apr 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prepandrix Group | Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21). |
| FG001 | Fluarix Group | Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Prepandrix Group | Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21). |
| BG001 | Fluarix 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 | Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 42 |
|
Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
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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 | Prepandrix Group | Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| 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 |
Not provided
| 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 |
|---|---|
| C023768 | halofantrine |
| D007854 | Lead |
| C510903 | fluarix |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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|
| Fluarix™ | Biological | 1 dose administered intramuscularly in the deltoid region of non-dominant arm. |
|
|
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. |
| At Day 0 and Day 21 |
| Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | At Day 21 |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). | At Day 21 |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | At Days 0 and 21 |
| Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | At Day 21 |
| Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | At Day 21 |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | At Day 0 and Day 21 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm. | During the 7-day (Day 0-6) period after each vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs). | Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | During the entire study period (From Day 0 to Day 182) |
| 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 21 days (Day 0-20) post-vaccination period |
| Number of Subjects Reporting Unsolicted 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 84-day (Days 0-83) post vaccination period |
| Number of Subjects Any Unsolicited 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | During the entire study period (From Day 0 to 182) |
| Gyeonggi-do |
| 442-723 |
| South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Seoul | 150-950 | South Korea |
Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 42 |
|
|
|
| Primary | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 42 |
|
|
|
| Primary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | Antibody titers were expressed as Geometric mean titers (GMTs). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 and Day 42 |
|
|
|
| Secondary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | Antibody titers were expressed as Geometric mean titers (GMTs). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 21 |
|
|
|
| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 0 and Day 21 |
|
|
|
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
|
|
|
| Secondary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Days 0 and 21 |
|
|
|
| Secondary | Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
|
|
|
| Secondary | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata). | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 0 and Day 21 |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm. | Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available. | Posted | Number | Subjects | During the 7-day (Day 0-6) period after each vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C | Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available. | Posted | Number | Subjects | During the 7-day (Days 0-6) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs). | Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available. | Posted | Number | Subjects | During the entire study period (From Day 0 to Day 182) |
|
|
|
| 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available. | Posted | Number | Subjects | During the 21 days (Day 0-20) post-vaccination period |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicted 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available. | Posted | Number | Subjects | During the 84-day (Days 0-83) post vaccination period |
|
|
|
| Secondary | Number of Subjects Any Unsolicited 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group |
|
|
|
| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available. | Posted | Number | Subjects | During the entire study period (From Day 0 to 182) |
|
|
|
| 1 |
| 84 |
| 81 |
| 84 |
| EG001 | Fluarix Group | Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm. | 0 | 47 | 40 | 47 |
| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Increased Sweating | General disorders | Systematic Assessment |
|
| Joint Pain | General disorders | Systematic Assessment |
|
| Muscles Aches | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nasopharyngitis | 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 |
| Title | Measurements |
|---|---|
|
| H3N2, Day 21 |
|
| Yamagata, Day 0 |
|
| Yamagata, Day 21 |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| H3N2, Day 21 |
|
| Yamagata, Day 0 |
|
| Yamagata, Day 21 |
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Related Fatigue |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Increased Sweating |
|
| Grade 3 Increased Sweating |
|
| Related Increased Sweating |
|
| Any Joint Pain |
|
| Grade 3 Joint Pain |
|
| Related Joint Pain |
|
| Any Muscle Aches |
|
| Grade 3 Muscle Aches |
|
| Related Muscle Aches |
|
| Any Shivering |
|
| Grade 3 Shivering |
|
| Related Shivering |
|
| Any Fever (≥ 38.0°C) |
|
| Grade 3 Fever (≥ 39.0°C) |
|
| Related Fever |
|