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The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent influenza vaccine GSK 2115160A Group 1 | Experimental | Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
|
| Quadrivalent influenza vaccine GSK 2115160A Group 2 | Experimental | Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
|
| Trivalent influenza vaccine GSK 2115160A Group 1 | Active Comparator | Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
|
| Trivalent influenza vaccine GSK 2115160A Group 2 | Active Comparator | Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' quadrivalent influenza vaccine | Biological | Single intramuscular dose on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens. | At Day 0 and Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. |
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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 | Hradec Králové | 500 03 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23688546 | Derived | Beran J, Peeters M, Dewe W, Raupachova J, Hobzova L, Devaster JM. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013 May 20;13:224. doi: 10.1186/1471-2334-13-224. |
| 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 |
|---|---|---|---|
| 111295 | 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 | Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| FG001 | Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| FG002 | Trivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| FG003 | Trivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| BG001 | Quadrivalent Influenza Vaccine GSK 2115160A Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. | Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens. | Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 0 and Day 21 |
|
Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
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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 | Quadrivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| GSK Biologicals' trivalent influenza vaccine | Biological | Single intramuscular dose on Day 0. |
|
| At Day 21 |
| HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. | Day 21 |
| Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. | At Days 0 and 21 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm). | During a 7 day (Days 0-6) follow-up period after vaccination |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). | During a 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination | During a 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination. | During a 7-day follow-up period (Days 0-6) after vaccination |
| Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues. | During the entire study period (Days 0-180) |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination | During a 21 day (Days 0-20) follow-up period after vaccination- |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | 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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | During the entire study period (Days 0-180) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111295 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111295 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111295 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111295 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111295 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111295 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Migrated/moved from study area |
|
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| BG002 | Trivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| BG003 | Trivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| OG002 | Trivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0. |
| OG003 | Trivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
|
|
| Secondary | Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. | A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. | Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Day 21 |
|
|
|
| Secondary | HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. | Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | Day 21 |
|
|
|
| Secondary | Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. | A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens. | Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Number | Subjects | At Days 0 and 21 |
|
|
|
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm). | Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed. | Posted | Number | Subjects | During a 7 day (Days 0-6) follow-up period after vaccination |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. | Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). | Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed. | Posted | Number | Subjects | During a 7-day follow-up period (Days 0-6) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination | Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed | Posted | Number | Subjects | During a 7-day follow-up period (Days 0-6) after vaccination |
|
|
|
| Secondary | Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. | Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination. | Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed | Posted | Number | Subjects | During a 7-day follow-up period (Days 0-6) after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). | MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues. | Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration. | Posted | Number | Subjects | During the entire study period (Days 0-180) |
|
|
|
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination | Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration. | Posted | Number | Subjects | During a 21 day (Days 0-20) follow-up period after vaccination- |
|
|
|
| Secondary | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | 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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration. | Posted | Number | Subjects | During the entire study period (Days 0-180) |
|
|
|
| 0 |
| 105 |
| 84 |
| 105 |
| EG001 | Quadrivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 0 | 105 | 90 | 105 |
| EG002 | Trivalent Influenza Vaccine GSK 2115160A Group 1 | Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 0 | 105 | 81 | 105 |
| EG003 | Trivalent Influenza Vaccine GSK 2115160A Group 2 | Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 | 1 | 105 | 72 | 105 |
| Redness | General disorders | Systematic Assessment |
|
| Swellling | General disorders | Systematic Assessment |
|
| Arthralgia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Myalgia | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Shivering | General disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/Wisconsin strain |
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| B/Malaysia strain |
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| B/Jiangsu strain |
|
| A/Wisconsin strain |
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| B/Malaysia strain |
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| B/Jiangsu strain |
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| A/Solomon Islands strain, Day 21 |
|
| A/Wisconsin strain, Day 0 |
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| A/Wisconsin strain, Day 21 |
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| B/Malaysia strain, Day 0 |
|
| B/Malaysia strain, Day 21 |
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| B/Jiangsu strain, Day 0 |
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| B/Jiangsu strain, Day 21 |
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| Grade 3 Pain |
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| Any Redness |
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| Grade 3 Redness |
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| Any Swelling |
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| Grade 3 Swelling |
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| Grade 3 Pain |
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| Any Redness |
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| Grade 3 Redness |
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| Any Swelling |
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| Grade 3 Swelling |
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| Grade 3 Arthralgia |
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| Related Arthralgia |
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| Any Fatigue |
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| Grade 3 Fatigue |
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| Related Fatigue |
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| Any Headache |
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| Grade 3 Headache |
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| Related Headache |
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| Any Myalgia |
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| Grade 3 Myalgia |
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| Related Myalgia |
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| Any Nausea |
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| Grade 3 Nausea |
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| Related Nausea |
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| Any Shivering |
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| Grade 3 Shivering |
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| Related Shivering |
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| Any Fever |
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| Grade 3 Fever |
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| Related Fever |
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| Grade 3 Arthralgia |
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| Related Arthralgia |
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| Any Fatigue |
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| Grade 3 Fatigue |
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| Related Fatigue |
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| Any Headache |
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| Grade 3 Headache |
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| Related Headache |
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| Any Myalgia |
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| Grade 3 Myalgia |
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| Related Myalgia |
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| Any Nausea |
|
| Grade 3 Nausea |
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| Related Nausea |
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| Any Shivering |
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| Grade 3 Shivering |
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| Related Shivering |
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| Any Fever |
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| Grade 3 Fever |
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| Related Fever |
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| AID |
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| Grade 3 unsolicited AE(s) |
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| Related unsolicited AE(s) |
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| Related SAE(s) |
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