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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000373-76 | EudraCT Number |
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The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HZ/su Lot A | Experimental | Subjects will receive Lot A of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot. |
|
| HZ/su Lot B | Experimental | Subjects will receive Lot B of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot. |
|
| HZ/su Lot C | Experimental | Subjects will receive Lot C of the HZ/su vaccine at 0 and 2 months. The HZ/su vaccine composed of unique randomized combinations of an adjuvant lot and one gE lot. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes Zoster vaccine (GSK 1437173A) | Biological | 2 doses administered intramuscularly in deltoid region of non-dominant arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL). | At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-gE Humoral Immunogenicity | Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL). | At Month 0 and Month 3 |
| Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA |
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Inclusion Criteria:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female aged 50 years or older at the time of the first vaccination.
Written informed consent obtained from the subject.
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:
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Previous vaccination against HZ or varicella.
Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
History of HZ.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Acute disease and/or fever at the time of enrollment.
Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating females.
Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
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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 |
|---|---|---|---|
| 29079101 | Background | Strezova A, Godeaux O, Aggarwal N, Leroux-Roels G, Lopez-Fauqued M, Van Damme P, Vanden Abeele C, Vastiau I, Heineman TC, Lal H. A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. Vaccine. 2017 Dec 4;35(48 Pt B):6700-6706. doi: 10.1016/j.vaccine.2017.10.017. Epub 2017 Oct 24. |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1437173A Lot A Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months. |
| FG001 | GSK1437173A Lot B Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. |
| At Month 3 |
| 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 = significant pain at rest, that prevented normal every day activities. | Within 7 days (Days 0-6) after each vaccine dose and across doses |
| Number of Days With Any Solicited Local Symptoms | The number of days with any local symptoms reported during the solicited post-vaccination period. | During the 7 days (Days 0-6) after each vaccine dose |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral 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 activity. Grade 3 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | Within 7 days (Days 0-6) after each vaccine dose and across doses |
| Number of Days With Any Solicited General Symptoms | The number of days with any general symptoms reported during the solicited post-vaccination period. | During the 7 days (Days 0-6) after each vaccine dose |
| Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | Potential immune-mediated diseases (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 first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14) |
| 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 30 days (Days 0-29) after each vaccination |
| Number of Subjects With Any 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. | From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14) |
| Wichita |
| Kansas |
| 67207 |
| United States |
| GSK Investigational Site | Milford | Massachusetts | 01757 | United States |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| GSK Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
| FG002 | GSK1437173A Lot C Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK1437173A Lot A Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
| BG001 | GSK1437173A Lot B Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
| BG002 | GSK1437173A Lot C Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value | Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL). | The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw. | Posted | Number | Subjects | At Month 3 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-gE Humoral Immunogenicity | Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 0 and Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. | The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw. | Posted | Number | Subjects | At Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 = significant pain at rest, that prevented normal every day activities. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptoms sheet filled in. | Posted | Number | Subjects | Within 7 days (Days 0-6) after each vaccine dose and across doses |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Any Solicited Local Symptoms | The number of days with any local symptoms reported during the solicited post-vaccination period. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment. | Posted | Median | Inter-Quartile Range | Days | During the 7 days (Days 0-6) after each vaccine dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral 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 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 Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptom sheets filled in. | Posted | Number | Subjects | Within 7 days (Days 0-6) after each vaccine dose and across doses |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Any Solicited General Symptoms | The number of days with any general symptoms reported during the solicited post-vaccination period. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment. | Posted | Median | Inter-Quartile Range | Days | During the 7 days (Days 0-6) after each vaccine dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | Potential immune-mediated diseases (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 Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered. | Posted | Number | Subjects | From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered. | Posted | Number | Subjects | During 30 days (Days 0-29) after each vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered. | Posted | Number | Subjects | From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14) |
|
Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
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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 | GSK1437173A Lot A Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months. | 13 | 218 | 202 | 218 | ||
| EG001 | GSK1437173A Lot B Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. | 14 | 217 | 201 | 217 | ||
| EG002 | GSK1437173A Lot C Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. | 20 | 216 | 198 | 216 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Post cholecystectomy syndrome | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreas infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertebral osteophyte | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuromyelitis optica spectrum disorder | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal claudication | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | 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 |
|---|---|
| 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 |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
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| Adjustd GMC Ratio |
| 0.96 |
| 2-Sided |
| 95 |
| 0.85 |
| 1.08 |
| Non-Inferiority or Equivalence (legacy) |
Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5] |
| ANCOVA | Adjusted GMC ratio | 0.99 | 2-Sided | 95 | 0.88 | 1.10 | Non-Inferiority or Equivalence (legacy) | Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]. |
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Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
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| OG002 |
| GSK1437173A Lot C Group |
Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
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| OG002 | GSK1437173A Lot C Group | Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months. |
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