Herpes Zoster
Conditions
Keywords
Immunocompromised, Safety, ≥ 18 years of age, Renal transplant, Adults, Immunosuppressed, Immunogenicity, Herpes zoster
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.
Interventions
BIOLOGICALHerpes Zoster vaccine GSK1437173A
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
DRUGPlacebo
2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 18 years or older and having reached the age of legal consent, on the date the informed consent is signed. * Written informed consent obtained from the subject. * Subject who has received an ABO compatible allogeneic renal transplant. * Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to the first vaccination. * Subject without an episode of allograft rejection over the previous three months (90 days) prior to the first vaccination. * Subject with stable renal function, stability defined as: * less than 20% variability between last two creatinine measurements or calculated GFR * or in the opinion of the investigator after investigator review of more than the last two creatinine measurements or calculated GFRs. * Subject not less than 4 months (120 days) and not more than 18 months (547 days) after allograft transplantation at the time of the first vaccination. * Subjects with multiple dialysis options (peritoneal and/or more than one anatomical access site for haemodialysis) in the event acute or chronic dialysis is needed. * 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: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of the first vaccination, and * has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Any primary kidney disease with a high incidence of recurrent primary kidney disease. * Evidence of recurrent primary kidney disease within the current allograft. * Previous allograft loss secondary to recurrent primary kidney disease. * Multiple kidney transplants are allowed if the reason for a previous allograft's loss is not recurrent primary kidney disease. * More than one organ transplanted (i.e. kidney-liver, double kidney or kidney-other organ(s) transplanted). * History of events that, in the opinion of the investigator, may put subject at increased risk for chronic allograft dysfunction (e.g. delayed graft function, peri-operative complications). * Histologic reports of chronic allograft injury (e.g. transplant glomerulopathy, arteriopathy, C4d deposition). * Evidence of significant proteinuria in the opinion of the investigator. * Panel reactive antibody score (PRA or cPRA) that is unknown at the time of transplant. * Any autoimmune or potential immune-mediated disease including primary kidney disease. * Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) of first dose of study vaccine/placebo. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. * Concurrent or planned participation in another clinical study, at any time during the study period, which has exposed or will expose the subject to an investigational or a non-registered product * Administration or planned administration of a live vaccine within 30 days prior to 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 within 8 days prior to or within 14 days after either dose of study vaccine. * Planned administration during the study of a varicella or HZ vaccine other than the study vaccine. * Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. * Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine/placebo. * Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit. * Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies. * Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment. * Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe. * Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. * Acute disease and/or fever at the time of vaccination. * Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Changes in Allograft Function | From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2). | Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented. |
| Number of Subjects With Solicited Local Symptoms | Within 7 days (Days 0-6) after each dose and across doses. | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Days With Solicited Local Symptoms | Within 7 days (Days 0-6) after each dose and overall/dose | Assessed solicited local symptoms were pain, redness and swelling. |
| Number of Subjects With Solicited General Symptoms | Within 7 days (Days 0-6) after each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain. |
| Days With Solicited General Symptoms | Within 7 days (Days 0-6) after each dose and overall/dose | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. |
| Number of Subjects With Unsolicited Symptoms (AEs) | During the 30-day (Days 0-29) post-vaccination period | 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. |
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From first vaccination (Month 0) up to 1 month post last vaccination (Month 2). | 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 |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From first vaccination (Month 0) up to 1 month post last vaccination (Month 2). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Renal Allograft Rejection | From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2). | Renal allograft rejection was confirmed through biopsy. |
| Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity | At Month 2. | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | At Months 1, 7 and 13 | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 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. Vaccine response was determined by ELISA. |
| Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | At Months 0, 2 and 13 | Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS). |
| Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells | At Months 2 and 13 | Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x\<320\> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies. |
| Number of Subjects With Any and Related SAEs | From 1 month post last vaccination (Month 2) until study end (Month 13). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any pIMDs | From 1 month post last vaccination (Month 2) until study end (Month 13). | 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. |
| Number of Subjects With Renal Allograft Rejection | From 1 month post last vaccination (Month 2) until study end (Month 13). | Renal allograft rejection was confirmed through biopsy. |
| Number of Subjects With Changes in Allograft Function | From 1 month post last vaccination (Month 2) until study end (Month 13) | Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented. |
| Anti-gE Antibody Concentrations | At Months 0, 1, 2, 7 and 13 | Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL. |
Countries
Belgium, Canada, Czechia, Finland, Italy, Panama, South Korea, Spain, Taiwan
Participant flow
Pre-assignment details
Out of 265 subjects originally enrolled in the study, only 264 subjects received vaccination and were hence included in the Total Vaccinated Cohort.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. | 132 |
| Control Group Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. | 132 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non-Serious Adverse Event | 1 | 0 |
| Overall Study | Serious Adverse Event | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | GSK1437173A Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 52.3 Years STANDARD_DEVIATION 12.5 | 52.4 Years STANDARD_DEVIATION 12.8 | 52.4 Years STANDARD_DEVIATION 12.6 |
| Race/Ethnicity, Customized African Heritage / African American | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 20 Participants | 22 Participants | 42 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 10 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized Unspecified | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 88 Participants | 97 Participants | 185 Participants |
| Sex: Female, Male Female | 38 Participants | 41 Participants | 79 Participants |
| Sex: Female, Male Male | 94 Participants | 91 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 132 | 1 / 132 |
| other Total, other adverse events | 121 / 132 | 78 / 132 |
| serious Total, serious adverse events | 26 / 132 | 33 / 132 |
Outcome results
Primary
Days With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\].
Time frame: Within 7 days (Days 0-6) after each dose and overall/dose
Population: The analysis was performed on the subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Group | Days With Solicited General Symptoms | Fatigue, Dose 1 | 3.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Fatigue, Dose 2 | 3.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Fatigue, Overall | 3.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 1 | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 2 | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Gastrointestinal symptoms, Overall | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Headache, Dose 1 | 1.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Headache, Dose 2 | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Headache, Overall | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Myalgia, Dose 1 | 3.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Myalgia, Dose 2 | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Myalgia, Overall | 3.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Shivering, Dose 1 | 2.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Shivering, Dose 2 | 1.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Shivering, Overall | 1.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Temperature, Dose 2 | 1.0 Days |
| GSK1437173A Group | Days With Solicited General Symptoms | Temperature, Overall | 1.0 Days |
| Control Group | Days With Solicited General Symptoms | Shivering, Dose 2 | 3.0 Days |
| Control Group | Days With Solicited General Symptoms | Fatigue, Dose 1 | 3.0 Days |
| Control Group | Days With Solicited General Symptoms | Myalgia, Dose 1 | 3.0 Days |
| Control Group | Days With Solicited General Symptoms | Fatigue, Dose 2 | 4.5 Days |
| Control Group | Days With Solicited General Symptoms | Temperature, Overall | 1.0 Days |
| Control Group | Days With Solicited General Symptoms | Fatigue, Overall | 4.0 Days |
| Control Group | Days With Solicited General Symptoms | Myalgia, Dose 2 | 7.0 Days |
| Control Group | Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 1 | 3.5 Days |
| Control Group | Days With Solicited General Symptoms | Shivering, Overall | 2.5 Days |
| Control Group | Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 2 | 2.0 Days |
| Control Group | Days With Solicited General Symptoms | Myalgia, Overall | 5.0 Days |
| Control Group | Days With Solicited General Symptoms | Gastrointestinal symptoms, Overall | 2.0 Days |
| Control Group | Days With Solicited General Symptoms | Temperature, Dose 2 | 1.0 Days |
| Control Group | Days With Solicited General Symptoms | Headache, Dose 1 | 2.0 Days |
| Control Group | Days With Solicited General Symptoms | Shivering, Dose 1 | 2.0 Days |
| Control Group | Days With Solicited General Symptoms | Headache, Dose 2 | 2.0 Days |
| Control Group | Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 Days |
| Control Group | Days With Solicited General Symptoms | Headache, Overall | 2.0 Days |
Primary
Days With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling.
Time frame: Within 7 days (Days 0-6) after each dose and overall/dose
Population: The analysis was performed on the subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Group | Days With Solicited Local Symptoms | Redness, Dose 2 | 3.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Pain, Overall | 3.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Redness, Overall | 4.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Swelling, Dose 1 | 4.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Pain, Dose 2 | 3.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Swelling, Dose 2 | 4.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Swelling, Overall | 4.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Redness, Dose 1 | 4.0 Days |
| GSK1437173A Group | Days With Solicited Local Symptoms | Pain, Dose 1 | 3.0 Days |
| Control Group | Days With Solicited Local Symptoms | Swelling, Overall | 4.0 Days |
| Control Group | Days With Solicited Local Symptoms | Pain, Dose 1 | 1.5 Days |
| Control Group | Days With Solicited Local Symptoms | Pain, Dose 2 | 1.0 Days |
| Control Group | Days With Solicited Local Symptoms | Pain, Overall | 1.0 Days |
| Control Group | Days With Solicited Local Symptoms | Redness, Dose 1 | 4.0 Days |
| Control Group | Days With Solicited Local Symptoms | Redness, Dose 2 | 2.0 Days |
| Control Group | Days With Solicited Local Symptoms | Swelling, Dose 1 | 4.0 Days |
| Control Group | Days With Solicited Local Symptoms | Redness, Overall | 3.0 Days |
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Time frame: From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Control Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs | 5 Participants |
| Control Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
Primary
Number of Subjects With Any 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
Time frame: From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Control Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Primary
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Time frame: At Month 2.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for humoral immunogenicity, which included all evaluable subjects up to Month 2, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity | 97 Participants |
| Control Group | Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity | 5 Participants |
Primary
Number of Subjects With Changes in Allograft Function
Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.
Time frame: From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Population: The analysis was performed on subjects with pre and post vaccination serum creatinine data available up to Month 2, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥1.20 fold increase | 5 Participants |
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥1.50 fold increase | 0 Participants |
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥1.75 fold increase | 0 Participants |
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥2 fold increase | 0 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥2 fold increase | 1 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥1.20 fold increase | 7 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥1.75 fold increase | 1 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥1.50 fold increase | 1 Participants |
Primary
Number of Subjects With Renal Allograft Rejection
Renal allograft rejection was confirmed through biopsy.
Time frame: From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Renal Allograft Rejection | Rejection confirmed | 0 Participants |
| GSK1437173A Group | Number of Subjects With Renal Allograft Rejection | Rejection not confirmed | 0 Participants |
| Control Group | Number of Subjects With Renal Allograft Rejection | Rejection confirmed | 0 Participants |
| Control Group | Number of Subjects With Renal Allograft Rejection | Rejection not confirmed | 3 Participants |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.
Time frame: Within 7 days (Days 0-6) after each dose and across doses
Population: The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 47 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 1 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. sympt., Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 14 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 13 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 2 | 23 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 2 | 9 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 21 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 43 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 49 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across doses | 62 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastro. sympt., Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across doses | 15 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastro. sympt., Across doses | 24 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. sympt., Across doses | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastro. sympt., Dose 1 | 17 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastro. sympt.,Across doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Gastro. sympt., Dose 2 | 14 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across doses | 44 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 11 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. sympt., Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across doses | 12 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 32 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose Across doses | 65 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Gastro. sympt., Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose Across doses | 9 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 1 | 10 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose Across doses | 21 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 35 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose Across doses | 29 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose Across doses | 4 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose Across doses | 11 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose Across doses | 31 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 9 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose Across doses | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose Across doses | 9 Participants |
| GSK1437173A Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 47 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose Across doses | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 1 | 42 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro. sympt., Dose 1 | 16 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. sympt., Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro. sympt., Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 1 | 25 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 1 | 23 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 1 | 13 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 1 | 6 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Dose 2 | 36 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro. sympt., Dose 2 | 14 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. sympt., Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro. sympt., Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Dose 2 | 22 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose 2 | 19 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose 2 | 9 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose 2 | 7 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Fatigue, Across doses | 53 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue, Across doses | 6 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Fatigue, Across doses | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Gastro. sympt., Across doses | 24 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastro. sympt., Across doses | 1 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Gastro. sympt.,Across doses | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Headache, Across doses | 34 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache, Across doses | 5 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Headache, Across doses | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Myalgia, Dose Across doses | 31 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Myalgia, Dose Across doses | 3 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Myalgia, Dose Across doses | 4 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Shivering, Dose Across doses | 16 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Shivering, Dose Across doses | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Related Shivering, Dose Across doses | 2 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Any Temperature, Dose Across doses | 13 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature, Dose Across doses | 0 Participants |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within 7 days (Days 0-6) after each dose and across doses.
Population: The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 107 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 10 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 24 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 10 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 93 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 9 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 21 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 11 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 114 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 13 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across doses | 33 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across doses | 15 Participants |
| GSK1437173A Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 1 | 8 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Across doses | 2 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Swelling, Across doses | 1 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Dose 2 | 6 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Pain, Across doses | 11 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
Primary
Number of Subjects With Unsolicited Symptoms (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.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Unsolicited Symptoms (AEs) | At least one symptom | 51 Participants |
| GSK1437173A Group | Number of Subjects With Unsolicited Symptoms (AEs) | Subjects with grade 3 AEs | 7 Participants |
| GSK1437173A Group | Number of Subjects With Unsolicited Symptoms (AEs) | Subjects with related AEs | 7 Participants |
| Control Group | Number of Subjects With Unsolicited Symptoms (AEs) | At least one symptom | 44 Participants |
| Control Group | Number of Subjects With Unsolicited Symptoms (AEs) | Subjects with grade 3 AEs | 5 Participants |
| Control Group | Number of Subjects With Unsolicited Symptoms (AEs) | Subjects with related AEs | 3 Participants |
Secondary
Anti-gE Antibody Concentrations
Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.
Time frame: At Months 0, 1, 2, 7 and 13
Population: The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | Anti-gE Antibody Concentrations | anti-gE, Month 1 | 9530.5 mIU/mL |
| GSK1437173A Group | Anti-gE Antibody Concentrations | anti-gE, Month 7 | 13066.7 mIU/mL |
| GSK1437173A Group | Anti-gE Antibody Concentrations | anti-gE, Month 2 | 19163.8 mIU/mL |
| GSK1437173A Group | Anti-gE Antibody Concentrations | anti-gE, Month 13 | 8545.1 mIU/mL |
| GSK1437173A Group | Anti-gE Antibody Concentrations | anti-gE, Month 0 | 1354.4 mIU/mL |
| Control Group | Anti-gE Antibody Concentrations | anti-gE, Month 13 | 1572.7 mIU/mL |
| Control Group | Anti-gE Antibody Concentrations | anti-gE, Month 0 | 1495.7 mIU/mL |
| Control Group | Anti-gE Antibody Concentrations | anti-gE, Month 1 | 1501.9 mIU/mL |
| Control Group | Anti-gE Antibody Concentrations | anti-gE, Month 2 | 1489.4 mIU/mL |
| Control Group | Anti-gE Antibody Concentrations | anti-gE, Month 7 | 1533.7 mIU/mL |
Secondary
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).
Time frame: At Months 0, 2 and 13
Population: The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | Month 0 | 110.9 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 182.09 |
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | Month 2 | 2433.07 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 2102.29 |
| GSK1437173A Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | Month 13 | 1320.92 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 1823.64 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | Month 0 | 165.75 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 242.92 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | Month 2 | 156.98 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 274.81 |
| Control Group | Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells | Month 13 | 129.41 gE-specific CD4+ T-cells/million T-cells | Standard Deviation 197.92 |
Secondary
Number of Subjects With Any and Related SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13).
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.If a subject reported a SAE exactly 1 month post-last vaccination (Month 2), it is possible that he/she might have also been taken into consideration for the Day0 up to Month2 SAEs assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any and Related SAEs | Any SAEs | 21 Participants |
| GSK1437173A Group | Number of Subjects With Any and Related SAEs | Related SAEs | 0 Participants |
| Control Group | Number of Subjects With Any and Related SAEs | Any SAEs | 29 Participants |
| Control Group | Number of Subjects With Any and Related SAEs | Related SAEs | 1 Participants |
Secondary
Number of Subjects With Any 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.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13).
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any pIMDs | 4 Participants |
| Control Group | Number of Subjects With Any pIMDs | 2 Participants |
Secondary
Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 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. Vaccine response was determined by ELISA.
Time frame: At Months 1, 7 and 13
Population: The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | anti-gE, Month 1 | 77 Participants |
| GSK1437173A Group | Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | anti-gE, Month 7 | 83 Participants |
| GSK1437173A Group | Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | anti-gE, Month 13 | 74 Participants |
| Control Group | Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | anti-gE, Month 1 | 3 Participants |
| Control Group | Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | anti-gE, Month 7 | 5 Participants |
| Control Group | Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity | anti-gE, Month 13 | 7 Participants |
Secondary
Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells
Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x\<320\> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.
Time frame: At Months 2 and 13
Population: The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells | Month 2 | 20 Participants |
| GSK1437173A Group | Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells | Month 13 | 17 Participants |
| Control Group | Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells | Month 2 | 0 Participants |
| Control Group | Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells | Month 13 | 0 Participants |
Secondary
Number of Subjects With Changes in Allograft Function
Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13)
Population: The analysis was performed on subjects with pre and post vaccination serum creatinine data available from Month 2 to Month 13, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥1.20 fold increase | 17 Participants |
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥1.50 fold increase | 4 Participants |
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥1.75 fold increase | 3 Participants |
| GSK1437173A Group | Number of Subjects With Changes in Allograft Function | ≥2 fold increase | 2 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥2 fold increase | 0 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥1.20 fold increase | 22 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥1.75 fold increase | 1 Participants |
| Control Group | Number of Subjects With Changes in Allograft Function | ≥1.50 fold increase | 3 Participants |
Secondary
Number of Subjects With Renal Allograft Rejection
Renal allograft rejection was confirmed through biopsy.
Time frame: From 1 month post last vaccination (Month 2) until study end (Month 13).
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Renal Allograft Rejection | Rejection confirmed | 4 Participants |
| GSK1437173A Group | Number of Subjects With Renal Allograft Rejection | Rejection not confirmed | 12 Participants |
| Control Group | Number of Subjects With Renal Allograft Rejection | Rejection confirmed | 7 Participants |
| Control Group | Number of Subjects With Renal Allograft Rejection | Rejection not confirmed | 13 Participants |