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The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1437173A Group | Experimental | Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later. |
|
| Control Group | Active Comparator | Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes Zoster vaccine GSK 1437173A | Biological | 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group | This outcome was required only for the GSK1437173A Group. Vaccine response 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 1 month post-Dose 2 (Month 3) |
| Antibody Concentrations Against Glycoprotein E (Anti-gE) | Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL. | At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group) |
| Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | At 1 month post-Dose 1 (Month 1) |
| Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | At 1 month post-Dose 1 (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm). "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses |
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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 with the study vaccine(s).
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 (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines).
Administration of long-acting immune-modifying drugs (e.g. infliximab) 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 vaccine/product (pharmaceutical product or device).
Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
History of HZ.
Vaccination against diphtheria, or tetanus in the last five years or planned vaccination against diphtheria or tetanus during the study period, other than the study vaccine(s).
Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any time prior to study entry.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines including prior severe allergic reaction following tetanus-toxoid, diphtheria-toxoid or pertussis-containing vaccine.
Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain latex.
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a previous pertussis antigen-containing vaccine.
Progressive or unstable neurologic disorder.
History of Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine within the last 10 years.
History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine containing tetanus toxoid.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85704 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31443993 | Derived | Strezova A, Lal H, Enweonye I, Campora L, Beukelaers P, Segall N, Heineman TC, Schuind AE, Oostvogels L. The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged >/=50 years: A randomized trial. Vaccine. 2019 Sep 16;37(39):5877-5885. doi: 10.1016/j.vaccine.2019.08.001. Epub 2019 Aug 20. |
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For one subject, the reason for withdrawal was incorrectly entered into the eCRF as "lost due to Crohn's disease." The subject withdrew from the study due to a combination of irritable bowel syndrome and time constraints associated with employment. This information was clarified after database freeze.
Not all subjects who were enrolled started the study due to elimination from statistical analyses or no vaccination received.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1437173A Group | Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later. |
| FG001 | Control Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Active Phase |
|
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| Boostrix | Biological | 1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups. |
|
| During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm). "0" implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups. 3. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses. | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Days With Solicited Symptoms | The number of days with local and general symptoms have been assessed during the solicited post-vaccination period. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
| Number of Subjects With Any and Related 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. Related = pIMDs assessed by the investigator as causally related to the study vaccination. | From first vaccination up to study end (Day 0 to 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. | Within the 30-day (Days 0-29) post-vaccination period |
| 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 study end (Day 0 to Month 14) |
| Tucson |
| Arizona |
| 85712 |
| United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Meridian | Idaho | 83642 | United States |
| GSK Investigational Site | Lewiston | Maine | 04240 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28114 | United States |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Greer | South Carolina | 29650 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | United States |
Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Safety Phase |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK1437173A Group | Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later. |
| BG001 | Control Group | Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart. |
| BG002 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group | This outcome was required only for the GSK1437173A Group. Vaccine response 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 According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available, only for subjects in the GSK1437173A Group. | Posted | Count of Participants | Participants | At 1 month post-Dose 2 (Month 3) |
|
|
| ||||||||||||||||||||||||||
| Primary | Antibody Concentrations Against Glycoprotein E (Anti-gE) | Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group) |
| |||||||||||||||||||||||||||
| Primary | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens | Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At 1 month post-Dose 1 (Month 1) |
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| Primary | Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens | Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At 1 month post-Dose 1 (Month 1) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm). "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses | The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm). "0" implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups. 3. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses. | The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose | Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses | The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed. | Posted | Count of Participants | Participants | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses |
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| Secondary | Number of Days With Solicited Symptoms | The number of days with local and general symptoms have been assessed during the solicited post-vaccination period. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses | The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed. | Posted | Mean | Inter-Quartile Range | Days | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Doses with the symptom | Doses with the symptom |
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| Secondary | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination. | The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination up to study end (Day 0 to Month 14) |
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| 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 vaccine administration documented. | Posted | Count of Participants | Participants | Within the 30-day (Days 0-29) post-vaccination period |
| ||||||||||||||||||||||||||||
| 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 analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination up to study end (Day 0 to Month 14) |
|
|
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at 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 Group | Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later. | 4 | 412 | 21 | 412 | 368 | 412 |
| EG001 | Control Group | Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart. | 5 | 418 | 31 | 418 | 380 | 418 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Surgical failure | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Burns third degree | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Staphylococcus test positive | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Carotid artery disease | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Device failure | Product Issues | MedDRA 20.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
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At the time of posting this record, only the safety and demography results until 1-month post-last vaccination (Co-ad group Month 3 and Control group Month 5) were available. The record will be updated once immunogenicity results become available.
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 |
|---|---|
| C505143 | Boostrix |
Not provided
Not provided
Not provided
| Protocol Violation |
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| Lost due to Crohn's disease |
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| Asian - Japanese Heritage |
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| White - Arabic/North African Heritage |
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| White - Caucasian/European Heritage |
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