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This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2321138A Lot 1 Group | Experimental | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK2321138A Lot 2 Group | Experimental | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK2321138A Lot 3 Group | Experimental | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
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| Fluarix Group | Active Comparator | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
| GSK2604409A Group | Active Comparator | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine GSK2321138A | Biological | One intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | At Day 0 (D 0), and at Day 21 (D 21) |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | At Day 21 (D 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects Against 4 Strains of Influenza Disease | A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
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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 | Chandler | Arizona | 85224 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23883186 | Derived | Kieninger D, Sheldon E, Lin WY, Yu CJ, Bayas JM, Gabor JJ, Esen M, Fernandez Roure JL, Narejos Perez S, Alvarez Sanchez C, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/=18 years. BMC Infect Dis. 2013 Jul 24;13:343. doi: 10.1186/1471-2334-13-343. |
| 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 |
|---|---|---|---|
| 114269 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Subjects receiving the GSK2321138A and Fluarixâ„¢ vaccines were followed in a double-blinded manner throughout the entire study period, from Day 0 to Day 180. Subjects receiving the GSK2604409A vaccine were followed in an open manner until Day 21 only.
A total of 4659 subjects (all aged 18 years and older at the time of their first vaccination as part of this study) were enrolled in this study, of which 4656 were vaccinated. The study vaccine dose was not administrated but subject number was allocated for the other 3 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2321138A Lot 1 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | GSK2321138A Lot 2 Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| FluarixTM | Biological | One intramuscular injection |
|
| Influenza vaccine GSK2604409A | Biological | One intramuscular injection |
|
| At Day 0 (D 0), and at Day 21 (D 21) |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | At Day 0 (D 0), and at Day 21 (D 21) |
| Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | At Day 21 (D 21) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | Within the 7-day (Days 0-6) follow-up period after vaccination |
| Number of Days With Solicited Local Symptoms | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. | Within the 7-day (Days 0-6) follow-up period after vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination. | Within the 7-day (Days 0-6) follow-up period after vaccination |
| Number of Days With Solicited General Symptoms | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)]. | Within the 7-day (Days 0-6) follow-up period after vaccination |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AEs cover 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 AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination. | Within the 21-day (Days 0-20) follow-up period after vaccination |
| Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | From the beginning of the study (Day 0) to study end (Day 180) |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | From the beginning of the study (Day 0) to study end (Day 180) |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination. | From the beginning of the study (Day 0) to study end (Day 180) |
| Miami |
| Florida |
| 33143 |
| United States |
| GSK Investigational Site | Newton | Kansas | 67114 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Columbia | Maryland | 21045 | United States |
| GSK Investigational Site | Milford | Massachusetts | 01757 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16506 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Tübingen | Baden-Wurttemberg | 72074 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86150 | Germany |
| GSK Investigational Site | Haag | Bavaria | 83527 | Germany |
| GSK Investigational Site | Finsterwalde | Brandenburg | 03238 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01277 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01309 | Germany |
| GSK Investigational Site | Freiberg | Saxony | 09599 | Germany |
| GSK Investigational Site | Berlin | 10367 | Germany |
| GSK Investigational Site | Berlin | 13086 | Germany |
| GSK Investigational Site | Brasov | 500260 | Romania |
| GSK Investigational Site | Brăila | 810384 | Romania |
| GSK Investigational Site | Bucharest | 020142 | Romania |
| GSK Investigational Site | Bucharest | 062289 | Romania |
| GSK Investigational Site | Bucharest | 077190 | Romania |
| GSK Investigational Site | Galati | 800494 | Romania |
| GSK Investigational Site | Galati | 800578 | Romania |
| GSK Investigational Site | Pantelimon | 77145 | Romania |
| GSK Investigational Site | PloieÅŸti | 100172 | Romania |
| GSK Investigational Site | Guro Gu | 152703 | South Korea |
| GSK Investigational Site | Gyeonggi-do | 442-723 | South Korea |
| GSK Investigational Site | Incheon | 400-711 | South Korea |
| GSK Investigational Site | Seoul | 150-719 | South Korea |
| GSK Investigational Site | Balenyà (Barcelona) | 08550 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Centelles | Spain |
| GSK Investigational Site | La Roca Del Valles (Barcelona) | 08430 | Spain |
| GSK Investigational Site | Vic/ Barcelona | 08500 | Spain |
| GSK Investigational Site | Taichung | 404 | Taiwan |
| GSK Investigational Site | Taipei | Taiwan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114269 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114269 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114269 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114269 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114269 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114269 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| FG002 | GSK2321138A Lot 3 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| FG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| FG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2321138A Lot 1 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | GSK2321138A Lot 2 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | GSK2321138A Lot 3 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| BG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| BG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| BG005 | 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 (D 0), and at Day 21 (D 21) |
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| Primary | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease | A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 (D 21) |
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| Secondary | Number of Seropositive Subjects Against 4 Strains of Influenza Disease | A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 0 (D 0), and at Day 21 (D 21) |
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| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 0 (D 0), and at Day 21 (D 21) |
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| Secondary | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease | Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At Day 21 (D 21) |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) follow-up period after vaccination |
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| Secondary | Number of Days With Solicited Local Symptoms | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. | Posted | Median | Inter-Quartile Range | Day | Within the 7-day (Days 0-6) follow-up period after vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) follow-up period after vaccination |
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| Secondary | Number of Days With Solicited General Symptoms | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)]. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. | Posted | Median | Inter-Quartile Range | Day | Within the 7-day (Days 0-6) follow-up period after vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Unsolicited AEs cover 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 AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within the 21-day (Days 0-20) follow-up period after vaccination |
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| Secondary | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From the beginning of the study (Day 0) to study end (Day 180) |
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| Secondary | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From the beginning of the study (Day 0) to study end (Day 180) |
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| Secondary | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From the beginning of the study (Day 0) to study end (Day 180) |
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Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180)
Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available.
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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 | GSK2321138A Lot 1 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 28 | 1,012 | 485 | 1,008 | ||
| EG001 | GSK2321138A Lot 2 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 20 | 1,013 | 472 | 1,003 | ||
| EG002 | GSK2321138A Lot 3 Group | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 22 | 1,011 | 482 | 1,004 | ||
| EG003 | Fluarix Group | Subjects received one dose of the 1 dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 26 | 1,010 | 500 | 1,003 | ||
| EG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | 1 | 610 | 275 | 607 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Central nervous system infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Rectal cancer ( | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Coma hepatic | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | General disorders | MedDRA | Systematic Assessment |
| |
| Joint pain | General disorders | MedDRA | Systematic Assessment |
| |
| Muscle aches | General disorders | MedDRA | Systematic Assessment |
|
Concerns arose about data integrity for a Romanian site (102 subjects) after completion of analysis. These data were not excluded from this reporting as they did not reveal irregularities and GSK does not plan to use them towards regulatory filing.
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
| Male |
|
| H1N1 Strain - D 21 |
|
|
| H3N2 Strain - D 0 |
|
|
| H3N2 Strain - D 21 |
|
|
| Victoria Strain - D 0 |
|
|
| Victoria Strain - D 21 |
|
|
| Yamagata Strain - D 0 |
|
|
| Yamagata Strain - D 21 |
|
|
| OG002 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| OG002 |
| GSK2604409A Group |
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| GSK2604409A Group |
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| OG002 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| OG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Fluarix Group |
Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| GSK2321138A Lot 3 Group |
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| OG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
|
|
|
|
Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
| OG003 | Fluarix Group | Subjects received one dose of the Fluarixâ„¢ vaccine at Day 0. The Fluarixâ„¢ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| OG004 | GSK2604409A Group | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
|
|
|
|
|
|
|
|
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|