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The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals' HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires before and after vaccination following a 2 month schedule. To estimate the impact of reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare subject questionnaire responses made during two periods, i.e., pre-vaccination and post-vaccination. The difference will be considered to be the effect of vaccination and reactogenicity on the PF and QoL. To characterize the study population and determine if frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects' frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine will be made by including a detailed collection of the use of healthcare resources and the occurrence of symptoms through diary card data collection. Impact on days of work loss, both for the subject or for a caregiver, as applicable, will also be assessed.
Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1437173A Group | Experimental | Subjects ≥ 50 years of age who will receive two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A) | Biological | 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose | Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | From Baseline at Day -7 to Day 8 after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose | Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. |
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Inclusion Criteria:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the questionnaires and diary cards).
Written informed consent obtained from the subject prior to performance of any study specific procedure.
A male or female aged ≥ 50 YOA at the time of consent.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
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 | Oakland | California | 94612 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30256905 | Derived | Schmader KE, Levin MJ, Grupping K, Matthews S, Butuk D, Chen M, Idrissi ME, Fissette LA, Fogarty C, Hartley P, Klein NP, Nevarez M, Uusinarkaus K, Oostvogels L, Curran D. The Impact of Reactogenicity After the First Dose of Recombinant Zoster Vaccine on the Physical Functioning and Quality of Life of Older Adults: An Open-Label, Phase III Trial. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1217-1224. doi: 10.1093/gerona/gly218. |
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A total of 404 subjects were enrolled in the study. However,1 subject was considered not eligible per the exclusion criteria (had previously received a Zoster vaccine) & 2 subjects were not vaccinated due to voluntary consent withdrawal.Hence,401 subjects were considered to have started the study & administered the first study vaccine (Exposed Set)
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1437173A Group | Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2017 | Apr 11, 2018 |
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| From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
| Change in Mean SF-36 PF Single Item Scores After First Dose | Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below. | From Baseline at Day -7 to Day 8 after first dose |
| Change in Mean SF-36 PF Single Item Scores After Second Dose | Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below. | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
| Change in SF-36 Role Physical Scores After First Dose | Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | From Baseline at Day -7 to Day 8 after first dose |
| Change in SF-36 Role Physical Scores After Second Dose | Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
| Change in Quality-adjusted Life Year (QALY) After First Dose | Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. | From Baseline at Day -7 to Day 8 after first dose |
| Change in QALY After Second Dose | Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life). | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
| Number of Reactogenicity-triggered Medically Attended Visits After First Dose | Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations. | From Day 1 to Day 7 after first dose |
| Number of Reactogenicity-triggered Medically Attended Visits After Second Dose | Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations. | From Day 1 to Day 7 after second dose |
| Days of Work Loss for Subjects After First Dose | Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days. | From Day 1 to Day 7 after first dose |
| Days of Work Loss for Subjects After Second Dose | Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days. | From Day 1 to Day 7 after second dose |
| Days of Work Loss for Non-dedicated Caregivers After First Dose | Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers | From Day 1 to Day 7 after first dose |
| Days of Work Loss for Non-dedicated Caregivers After Second Dose | Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers | From Day 1 to Day 7 after second dose |
| Days of Extra Work for Dedicated Caregivers After First Dose | Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers | From Day 1 to Day 7 after first dose |
| Days of Extra Work for Dedicated Caregivers After Second Dose | Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers | From Day 1 to Day 7 after second dose |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose | Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site. | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose | Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site. | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
| Number of Days With Solicited Local Symptoms After First Dose | Assessed solicited local symptoms were pain, erythema and swelling. | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
| Number of Days With Solicited Local Symptoms After Second Dose | Assessed solicited local symptoms were pain, erythema and swelling. | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
| Number of Days With Solicited General Symptoms After First Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
| Number of Days With Solicited General Symptoms After Second Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses). |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | From Day 1 to study end at Month 14 |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | pIMDs are 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. | From Day 1 to study end at Month 14 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80906 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80922 | United States |
| GSK Investigational Site | Meridian | Idaho | 83646 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64114 | United States |
| GSK Investigational Site | Durham | North Carolina | 27705 | United States |
| GSK Investigational Site | Corvallis | Oregon | 97330 | United States |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1437173A Group | Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. |
| 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 | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose | Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Baseline at Day -7 to Day 8 after first dose |
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| Secondary | Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose | Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
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| Secondary | Change in Mean SF-36 PF Single Item Scores After First Dose | Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Baseline at Day -7 to Day 8 after first dose |
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| Secondary | Change in Mean SF-36 PF Single Item Scores After Second Dose | Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
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| Secondary | Change in SF-36 Role Physical Scores After First Dose | Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Baseline at Day -7 to Day 8 after first dose |
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| Secondary | Change in SF-36 Role Physical Scores After Second Dose | Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
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| Secondary | Change in Quality-adjusted Life Year (QALY) After First Dose | Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Baseline at Day -7 to Day 8 after first dose |
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| Secondary | Change in QALY After Second Dose | Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life). | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Mean | Standard Deviation | Score units | From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68) |
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| Secondary | Number of Reactogenicity-triggered Medically Attended Visits After First Dose | Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Number | Visits | From Day 1 to Day 7 after first dose |
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| Secondary | Number of Reactogenicity-triggered Medically Attended Visits After Second Dose | Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Number | Visits | From Day 1 to Day 7 after second dose |
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| Secondary | Days of Work Loss for Subjects After First Dose | Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days. | The analysis was performed on the total number of subjects who reported work loss after the first vaccination and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered | Posted | Mean | Standard Deviation | Days | From Day 1 to Day 7 after first dose |
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| Secondary | Days of Work Loss for Subjects After Second Dose | Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days. | The analysis was performed on the total number of subjects who reported work loss after the second dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered | Posted | Mean | Standard Deviation | Days | From Day 1 to Day 7 after second dose |
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| Secondary | Days of Work Loss for Non-dedicated Caregivers After First Dose | Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers | The analysis was performed on the total number of non-dedicated caregivers who reported work loss after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered | Posted | From Day 1 to Day 7 after first dose |
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| Secondary | Days of Work Loss for Non-dedicated Caregivers After Second Dose | Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers | The analysis was performed on the total number of non-dedicated caregivers who reported work loss after second dose and were a part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | From Day 1 to Day 7 after second dose |
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| Secondary | Days of Extra Work for Dedicated Caregivers After First Dose | Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers | The analysis was performed on the total number of dedicated caregivers who reported extra work after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | From Day 1 to Day 7 after first dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Days of Extra Work for Dedicated Caregivers After Second Dose | Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers | The analysis was performed on the total number of dedicated caregivers who reported extra work after second dose and were part of the exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | From Day 1 to Day 7 after second dose |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose | Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose | Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Days With Solicited Local Symptoms After First Dose | Assessed solicited local symptoms were pain, erythema and swelling. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Median | Inter-Quartile Range | Days | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Days With Solicited Local Symptoms After Second Dose | Assessed solicited local symptoms were pain, erythema and swelling. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Median | Inter-Quartile Range | Days | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Days With Solicited General Symptoms After First Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Median | Inter-Quartile Range | Days | During a 7-day follow-up period (Day 1 to Day 7) after first dose. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Days With Solicited General Symptoms After Second Dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Median | Inter-Quartile Range | Days | During a 7-day follow-up period (Day 1 to Day 7) after second dose. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses). |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | From Day 1 to study end at Month 14 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | pIMDs are 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. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered. | Posted | Count of Participants | Participants | From Day 1 to study end at Month 14 |
|
|
Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
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 | GSK1437173A Group | Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study. | 2 | 401 | 14 | 401 | 370 | 401 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve stenosis | Cardiac disorders | 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 20.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | 20.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | 20.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 20.1 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | 20.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 20.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 20.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 20.1 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.1 | Systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | 20.1 | Systematic Assessment |
| |
| Death | General disorders | 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Atrial fibrilation | Cardiac disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Vertigo | Ear and labyrinth disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Conjunctivitis allergic | Eye disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Eye irritation | Eye disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Eye pain | Eye disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Keratitis | Eye disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Constipation | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Diarrhoea | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Gastrointestinal disorder | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Haematochezia | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Haemorrhoids | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Nausea | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Toothache | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Vomiting | Gastrointestinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Application site erythema | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Application site hyperaesthesia | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Chills | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Fatigue | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Feeling cold | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Ill-defined disorder | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Inflammation | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Injection site bruising | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| injection site erythema | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Injection site pain | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Injection site pruritus | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Injection site warmth | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Malaise | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Oedema peripheral | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Pain | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Peripheral swelling | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Pyrexia | General disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Seasonal allergy | Immune system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Bronchitis | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Cystitis | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Eye infection staphilococcal | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Fungal infection | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Gastroenteritis viral | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Gastrointestinal viral infection | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Groin abcess | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Nasopharyngithis | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Oral herpes | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Pneumonia | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Rhinitis | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Sinusitis | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Tooth abcess | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Tooth infection | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Upper respiratory tract infection | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Urinary tract infection | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Viral infection | Infections and infestations | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Arthropod bite | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Arthropod sting | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Fall | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Foot fracture | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Injection related reaction | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Ligament sprain | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Meniscus injury | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Procedural dizziness | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Procedural pain | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Skin laceration | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Superficial injury of eye | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Tooth fracture | Injury, poisoning and procedural complications | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Decreased appetite | Metabolism and nutrition disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Gout | Metabolism and nutrition disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Back pain | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Bursitis | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Dizziness | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Headache | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Hypoaesthesia | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Lethargy | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Migraine | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Paraesthesia | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Sciatica | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Sinus headache | Nervous system disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Anxiety | Psychiatric disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Insomnia | Psychiatric disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Panic attack | Psychiatric disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Stress | Psychiatric disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Nephrolithiasis | Renal and urinary disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Urinary tract disorder | Renal and urinary disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Urine odour abnormal | Renal and urinary disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Pelvic pain | Reproductive system and breast disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Dermatitis | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Erythema | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Night sweats | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Rash | Skin and subcutaneous tissue disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Sinus operation | Surgical and medical procedures | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Flushing | Vascular disorders | 20.1 | Systematic Assessment | Unsolicited symptoms |
|
| Injection site swelling | General disorders | 20.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 16, 2016 | Apr 11, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| Other |
|
| White - Arabic / North African Heritage |
|
| White - Caucasian / European Heritage |
|
|
|
| Participants |
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| Counts |
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| Participants |
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| Participants |
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