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The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2340274A Group | Experimental | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| GSK2340273A Group | Experimental | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2340274A | Biological | One intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. | At Day 21 |
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 0 |
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 21 |
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance. | At Day 21 |
| Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Days 0 and 21 |
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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 | Mesa | Arizona | 85213 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23856331 | Derived | Yang WH, Dionne M, Kyle M, Aggarwal N, Li P, Madariaga M, Godeaux O, Vaughn DW. Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: an observer-blind, randomized trial. Vaccine. 2013 Sep 13;31(40):4389-97. doi: 10.1016/j.vaccine.2013.07.007. Epub 2013 Jul 12. |
| 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 |
|---|---|---|---|
| 113480 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2340274A Group | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSK2340273A |
| Biological |
One intramuscular injection |
|
The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases. |
| From Day 14 post-vaccination up to study end (at Day 385) |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Days 0 and 21 |
| Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 42 |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 42 |
| Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 182 |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 182 |
| Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 42 |
| Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 182 |
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 42 |
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | At Day 182 |
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP. | At Day 42 |
| Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP. | At Day 182 |
| Number of A/California Influenza Related Cases | Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia. | From Day 0 up to the end of ILI surveillance (Day 385) |
| Number of ILI Symptoms in All Reported ILI Cases | Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue. | From Day 0 up to the end of ILI surveillance (Day 385) |
| Number of ILI Symptoms in All Reported ILI Cases | Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue. | From Day 14 post-vaccination through the end of ILI surveillance (Day 385) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | During the 7-day (Days 0-6) post-vaccination period |
| Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y). | At Days 7 and 21 |
| Number of Subjects With Any Medically-attended Adverse Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | Throughout the entire study period (Day 0 - Day 385) |
| Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) represent 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | Throughout the entire study period (Day 0 - Day 385) |
| Number of Subjects With Any 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | Within the 42-day (Days 0-41) post-vaccination period |
| Number of Subjects With 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 or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | Throughout the entire study period (Day 0 - Day 385) |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85028 | United States |
| GSK Investigational Site | Los Angeles | California | 90057 | United States |
| GSK Investigational Site | Clearwater | Florida | 33761 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Delray Beach | Florida | 33484 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32205 | United States |
| GSK Investigational Site | Chicago | Illinois | 60610 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Columbia | Maryland | 21045 | United States |
| GSK Investigational Site | Rockville | Maryland | 20850 | United States |
| GSK Investigational Site | Milford | Massachusetts | 01757 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64114 | United States |
| GSK Investigational Site | Somers Point | New Jersey | 08244 | United States |
| GSK Investigational Site | Binghamton | New York | 13901 | United States |
| GSK Investigational Site | Camillus | New York | 13031 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Willoughby Hills | Ohio | 44094 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16506 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
| GSK Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| GSK Investigational Site | Bay Roberts | Newfoundland and Labrador | A0A 1G0 | Canada |
| GSK Investigational Site | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3T1 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| GSK Investigational Site | London | Ontario | N5W 6A2 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| GSK Investigational Site | Gatineau | Quebec | J8Y 6S8 | Canada |
| GSK Investigational Site | Québec | Quebec | G1E 7G9 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | St-Romulad | Quebec | G6W 5M6 | Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113480 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113480 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113480 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113480 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113480 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113480 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GSK2340273A Group |
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2340274A Group | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG001 | GSK2340273A Group | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| Race/Ethnicity, Customized | 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 | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Posted | Count of Participants | Participants | At Day 21 |
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| Primary | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Posted | Count of Participants | Participants | At Day 0 |
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| Primary | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Posted | Count of Participants | Participants | At Day 21 |
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| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 21 |
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| Primary | Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases | The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases. | The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit. | Posted | Number | Events | From Day 14 post-vaccination up to study end (at Day 385) |
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| Secondary | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Posted | Count of Participants | Participants | At Days 0 and 21 |
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| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Days 0 and 21 |
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| Secondary | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Posted | Count of Participants | Participants | At Day 42 |
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| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 42 |
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| Secondary | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available. | Posted | Count of Participants | Participants | At Day 182 |
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| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 182 |
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| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Posted | Count of Participants | Participants | At Day 42 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available. | Posted | Count of Participants | Participants | At Day 182 |
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| Secondary | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Posted | Count of Participants | Participants | At Day 42 |
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| Secondary | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. | The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available. | Posted | Count of Participants | Participants | At Day 182 |
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| Secondary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP. | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 42 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP. | The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 182 |
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| Secondary | Number of A/California Influenza Related Cases | Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia. | The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit. | Posted | Number | Events | From Day 0 up to the end of ILI surveillance (Day 385) |
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| Secondary | Number of ILI Symptoms in All Reported ILI Cases | Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue. | The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit. | Posted | Number | Events | From Day 0 up to the end of ILI surveillance (Day 385) |
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| Secondary | Number of ILI Symptoms in All Reported ILI Cases | Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue. | The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit. | Posted | Number | Events | From Day 14 post-vaccination through the end of ILI surveillance (Day 385) |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period |
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| Secondary | Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels | Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | At Days 7 and 21 |
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| Secondary | Number of Subjects With Any Medically-attended Adverse Events (MAEs) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Throughout the entire study period (Day 0 - Day 385) |
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| Secondary | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) represent 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Throughout the entire study period (Day 0 - Day 385) |
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| Secondary | Number of Subjects With Any 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. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within the 42-day (Days 0-41) post-vaccination period |
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| Secondary | Number of Subjects With 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 or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Throughout the entire study period (Day 0 - Day 385) |
|
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period. Serious adverse events (SAE): during the entire study period (Day 0 to Day 385).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2340274A Group | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. | 6 | 2,025 | 84 | 2,025 | 1,680 | 2,025 |
| EG001 | GSK2340273A Group | Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. | 1 | 2,023 | 73 | 2,023 | 1,063 | 2,023 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Splenic vein thrombosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastric fistula | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Electrocardiogram st segment elevation | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Enzyme activity decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchioloalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Follicle centre lymphoma, follicular grade i, ii, iii stage iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Paget's disease of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urethral perforation | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stevens-johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 14.0 | 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
| Male |
|
| American Indian or Alaskan native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - Japanese Heritage |
|
| Asian - South East Asian Heritage |
|
| Native Hawaiian or other Pacific Islander |
|
| White - Arabic/North African Heritage |
|
| White - Caucasian/European Heritage |
|
| Other |
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG002 |
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG002 |
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| GSK2340273A (18-60 y) Group |
Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>60 y) Group | Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG004 | GSK2340274A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG005 | GSK2340274A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG006 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG007 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG002 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG002 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
|
|
| OG002 | GSK2340273A (18-64 y) Group | Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
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| OG003 | GSK2340273A (>64 y) Group | Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
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