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| ID | Type | Description | Link |
|---|---|---|---|
| 107217 | Other Identifier | GSK |
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Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
This study has 2 phases:
The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.
The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1562902A Group | Experimental | Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses. |
|
| Fluarix+Placebo Group | Active Comparator | Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted pandemic influenza candidate vaccine | Biological | 2 doses, intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter | During a 7 day follow-up period after each dose of vaccine and overall. |
| Number of Subjects With Solicited General Symptoms (Dose 1) | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. | During the 7-day (Days 0-6) after Dose 1 |
| Number of Subjects With Solicited General Symptoms (Dose 2) | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. | During the 7-day (Days 0-6) after Dose 2 |
| Number of Subjects With Solicited General Symptoms (Across Doses) | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs). | At Day 0 (PRE), 21 and 42 |
| Number of Seroconverted Subjects Against H5N1 |
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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 | Tallinn | 10617 | Estonia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18407382 | Derived | Rumke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Drame M, Sanger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27. |
| 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 |
|---|---|---|---|
| 107064 | Informed Consent 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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Out of the 5075 subjects enrolled in this study, 4 subjects did not receive any study vaccine and were hence excluded from study start.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1562902A Group | Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses. |
| FG001 | Fluarix+Placebo Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluarix | Biological | One intramuscular injection |
|
| Placebo | Biological | One intramuscular injection |
|
| During the 7-day (Days 0-6) post vaccination across dosses |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available. | During the 21st Day (Days 0-20) post Dose 1 |
| Number of Subjects With AEs | An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available. | During the 30 Day (Days 0-29) post Dose 2 |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From Day 0 to Day 180 |
| Number of Subjects With New Onset Chronic Diseases (NOCDs) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. | From Day 0 to Day 180 |
| Number of Subjects With Medically Significant Conditions (MSCs) | MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | From Day 0 to Day 51 |
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
| At Day 21 and Day 42 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0. | At Day 21 and Day 42 |
| Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection. | At Day 0 (PRE), Day 21 and Day 42 |
| Tartu |
| 50417 |
| Estonia |
| GSK Investigational Site | Caen | 14052 | France |
| GSK Investigational Site | Lagord | 17140 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75877 | France |
| GSK Investigational Site | Poitiers | 86000 | France |
| GSK Investigational Site | Rouen | 76100 | France |
| GSK Investigational Site | Munich | Bavaria | 80799 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81667 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93053 | Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30519 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58455 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01067 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04229 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | 14057 | Germany |
| GSK Investigational Site | Hamburg | 20249 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Rotterdam | 3011 EN | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 GE | Netherlands |
| GSK Investigational Site | Kazan' | 420015 | Russia |
| GSK Investigational Site | Novokuznetsk | 654063 | Russia |
| GSK Investigational Site | Saratov | Russia |
| GSK Investigational Site | Yekaterinburg | 620028 | Russia |
| GSK Investigational Site | Yekaterinburg | 620078 | Russia |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Marid | 28040 | Spain |
| GSK Investigational Site | Valencia | 46014 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden |
| GSK Investigational Site | Stockholm | SE-141 86 | Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107064 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107064 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107064 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107064 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register. |
| 107064 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1562902A 18-60 YOA Group | Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. |
| BG001 | GSK1562902A >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. |
| BG002 | Fluarix+Placebo 18-60 YOA Group | Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
| BG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
| BG004 | 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 |
| |||||||||||||||
| 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 | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter | The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During a 7 day follow-up period after each dose of vaccine and overall. |
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| Primary | Number of Subjects With Solicited General Symptoms (Dose 1) | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. | The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) after Dose 1 |
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| Primary | Number of Subjects With Solicited General Symptoms (Dose 2) | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. | The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) after Dose 2 |
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| Primary | Number of Subjects With Solicited General Symptoms (Across Doses) | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination. | The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post vaccination across dosses |
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| Primary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available. | The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in at Day 51. | Posted | Count of Participants | Participants | During the 21st Day (Days 0-20) post Dose 1 |
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| Primary | Number of Subjects With AEs | An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available. | The analysis was performed on the TVc which included all subjects who had received the second dose and for whom data were available. | Posted | Count of Participants | Participants | During the 30 Day (Days 0-29) post Dose 2 |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180. | Posted | Count of Participants | Participants | From Day 0 to Day 180 |
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| Primary | Number of Subjects With New Onset Chronic Diseases (NOCDs) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180. | Posted | Count of Participants | Participants | From Day 0 to Day 180 |
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| Primary | Number of Subjects With Medically Significant Conditions (MSCs) | MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | The analysis was performed on the TVc which included all vaccinated subjects for whom data were available at Day 51. | Posted | Count of Participants | Participants | From Day 0 to Day 51 |
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| Secondary | Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 | Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 0 (PRE), 21 and 42 |
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| Secondary | Number of Seroconverted Subjects Against H5N1 | Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination. | Posted | Count of Participants | Participants | At Day 21 and Day 42 |
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| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer fold increase | At Day 21 and Day 42 |
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| Secondary | Number of Seroprotected Subjects Against A/Vietnam Influenza Strain | Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination. | Posted | Count of Participants | Participants | At Day 0 (PRE), Day 21 and Day 42 |
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Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180.
During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
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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 | GSK1562902A 18-60 YOA Group | Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. | 27 | 3,397 | 3,189 | 3,397 | ||
| EG001 | GSK1562902A >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. | 15 | 405 | 338 | 405 | ||
| EG002 | Fluarix+Placebo 18-60 YOA Group | Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. | 10 | 1,136 | 938 | 1,136 | ||
| EG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. | 5 | 133 | 83 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Cardiac valve | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 9.1 | Systematic Assessment |
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| Macular hole | Eye disorders | MedDRA 9.1 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Groin abscess | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Mediastinitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Genital injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Heat stroke | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| Diabetes mellitus noninsulindependent | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| Vitamin b12 deficiency | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 9.1 | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 9.1 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bartholinís cyst | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Induration | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Redness | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Arthralgia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Myalgia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Shivering | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sweating | General disorders | MedDRA 9.1 | 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.
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
Not provided
| Male |
|
| Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133] |
|
| Any Induration, Dose 1[N=3342;403;1123;133] |
|
| Grade 3 Induration, Dose 1[N=3342;403;1123;133] |
|
| Any Pain, Dose 1[N=3342;403;1123;133] |
|
| Grade 3 Pain, Dose 1[N=3342;403;1123;133] |
|
| Any Redness, Dose 1[N=3342;403;1123;133] |
|
| Grade 3 Redness, Dose 1[N=3342;403;1123;133] |
|
| Any Swelling, Dose 1[N=3342;403;1123;133] |
|
| Grade 3 Swelling, Dose 1[N=3342;403;1123;133] |
|
| Any Ecchymosis, Dose 2 [N=3247;395;1102;132] |
|
| Grade 3 Ecchymosis, Dose 2 [N=3247;395;1102;132] |
|
| Any Induration, Dose 2 [N=3247;395;1102;132] |
|
| Grade 3 Induration, Dose 2 [N=3247;395;1102;132] |
|
| Any Pain, Dose 2 [N=3247;395;1102;132] |
|
| Grade 3 Pain, Dose 2 [N=3247;395;1102;132] |
|
| Any Redness, Dose 2 [N=3247;395;1102;132] |
|
| Grade 3 Redness, Dose 2 [N=3247;395;1102;132] |
|
| Any Swelling, Dose 2 [N=3247;395;1102.132] |
|
| Grade 3 Swelling, Dose 2 [N=3247;395;1102;132] |
|
| Any Ecchymosis, Across [N=3343;403;1123;133] |
|
| Grade 3 Ecchymosis, Across [N=3343;403;1123;133] |
|
| Any Induration, Across [N=3343;403;1123;133] |
|
| Grade 3 Induration, Across [N=3343;403;1123;133] |
|
| Any Pain, Across [N=3343;403;1123;133] |
|
| Grade 3 Pain, Across [N=3343;403;1123;133] |
|
| Any Redness, Across [N=3343;403;1123;133] |
|
| Grade 3 Redness, Across [N=3343;403;1123;133] |
|
| Any Swelling, Across [N=3343;1123;133] |
|
| Grade 3 Swelling, Across [N=3343;1123;133] |
|
Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| OG002 | Fluarix+Placebo 18-60 YOA Group | Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| Fluarix+Placebo 18-60 YOA Group |
Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| OG003 |
| Fluarix+Placebo >60 YOA Group |
Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| Fluarix+Placebo 18-60 YOA Group |
Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|
| OG003 | Fluarix+Placebo >60 YOA Group | Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. |
|
|