Herpes Zoster, Herpes Zoster Vaccine
Conditions
Keywords
≥18 years of age, Chemotherapy, Solid tumours, Immunogenicity, Herpes Zoster, Safety, Shingles
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.
Detailed description
The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle: * The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle, * The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle. The protocol summary has been updated following Protocol Amendment 2, August 2014, leading to the increase of the enrolment.
Interventions
BIOLOGICALGSK 1437173A
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
DRUGPlacebo
2 doses administered by IM injection into the deltoid muscle 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. * Written informed consent obtained from the subject. * A male or female aged 18 years or older (and has reached the age of legal consent) at the time of study entry (i.e., when informed consent is signed). * Subject who has been diagnosed with one or more solid tumours (defined as a solid malignancy, i.e., not a blood element malignancy). * Subject who is receiving or will receive a cytotoxic or immunosuppressive chemotherapy (such that the study vaccine can be administered at the latest at the start of the second cycle of chemotherapy). * Life expectancy of greater than one year. * Female subjects of non-childbearing potential may be enrolled in the study: * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause; * 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 vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Subjects receiving only newer, more targeted therapies if not taken together with a classical chemotherapy. * Chronic administration and/or planned administration of systemic glucocorticoids within one month prior to the first vaccine dose and up to Visit 3 (Month 2). Inhaled, intra-articularly injected, and topical steroids are allowed. * Previous vaccination against HZ or varicella within 12 months preceding the first dose of study vaccine/ placebo. * Planned administration during the study of a HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine. * Previous chemotherapy course less than one month before first study vaccination. * Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/ placebo. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment. * Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. * HIV infection by clinical history. * Acute disease and/or fever at the time of vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever, but excludes the underlying malignancy, as well as the expected symptoms/signs associated with that disease or its treatment: * Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting. 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 receive the first dose of study vaccine/ placebo at the discretion of the investigator. * Any condition which, in the judgment of the investigator would make intramuscular injection unsafe. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e., 2 months after the last dose of study vaccine/ placebo).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | From first vaccination up to 30 days post last vaccination | 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. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following 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 that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Days With Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose | The number of days with any local symptoms has been assessed during the post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal \[symptoms included nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and fever \[defined as oral, axillary or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose | The number of days with any general symptoms has been assessed during the post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 Serious Adverse Events (SAEs) | From first dose up to 30 days post last vaccination | 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. Related SAE= SAE assessed by the investigator as causally related to the study vaccination. |
| Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups | At Month 2 | Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only. |
| Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations | At Month 2 | Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | At Months 1, 2, 6 and 13 | 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. |
| Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | At Months 0, 1, 2 and 13 | Descriptive statistics were tabulated for CD4\[2+\] cells, which are gE specific CD4+ T-cells with at least two activation markers (\[2+\]), expressed from the activation markers interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40-ligand (CD40-L), as determined by intracellular cytokine staining (ICS) method. |
| Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | At Months 1, 2 and 13 | Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive 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 Serious Adverse Events (SAEs) | From 30 days post last vaccination up to 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 = SAE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs) | From 30 days post last vaccination up to study end (Month 13) | 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. |
| Anti-VZV gE Antibody Concentrations | At Months 0, 1, 6 and 13 | Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL. |
Countries
Canada, Czechia, France, South Korea, Spain, United Kingdom
Participant flow
Pre-assignment details
Out of the 237 subjects initially enrolled in the study, only 232 subject were included in the Total Vaccinated Cohort.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients. | 117 |
| Placebo Group Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients. | 115 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Migrated/moved from study area | 1 | 1 |
| Overall Study | Other | 0 | 2 |
| Overall Study | Serious Adverse Event | 13 | 12 |
| Overall Study | Withdrawal by Subject | 12 | 9 |
Baseline characteristics
| Characteristic | GSK1437173A Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 57.1 Years STANDARD_DEVIATION 10.8 | 58.5 Years STANDARD_DEVIATION 11.7 | 57.79 Years STANDARD_DEVIATION 11.25 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage/African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 11 Participants | 14 Participants | 25 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian Heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Missing | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Geographic ancestry Mixed Origin | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European Heritage | 92 Participants | 88 Participants | 180 Participants |
| Sex: Female, Male Female | 70 Participants | 69 Participants | 139 Participants |
| Sex: Female, Male Male | 47 Participants | 46 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 117 | 11 / 115 |
| other Total, other adverse events | 113 / 117 | 103 / 115 |
| serious Total, serious adverse events | 36 / 117 | 42 / 115 |
Outcome results
Primary
Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups
Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.
Time frame: At Month 2
Population: The analysis was performed on the PreChemo groups from the According-to-Protocol (ATP) cohort for Humoral immunogenicity which included all evaluable subjects up to 30 days post last vaccination and who had met all eligibility criteria and complied with the procedures and intervals defined in the protocol for active phase of the study.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A-PreChemo | Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups | 24501.57 EL.U/mL |
| Placeb-PreChemo | Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups | 1056.77 EL.U/mL |
Comparison: The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).95% CI: [17.9, 30]
Primary
Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations
Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.
Time frame: At Month 2
Population: The analysis was performed on the ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time point Month 2 data were obtained from the ATP cohort for Humoral Immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A-PreChemo | Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations | 18291.7 mIU/mL |
| Placeb-PreChemo | Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations | 1060.5 mIU/mL |
Primary
Number of Days With Solicited General Symptoms
The number of days with any general symptoms has been assessed during the post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 3.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 5.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 1 | 2.5 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 2 | 4.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 2.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 2.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Myalgia, Dose 1 | 2.5 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Myalgia, Dose 2 | 3.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 2.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 3.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 1.5 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Temperature, Dose 1 | 1.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Fatigue, Dose 1 | 5.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Myalgia, Dose 1 | 2.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Fatigue, Dose 2 | 5.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Shivering, Dose 2 | 2.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 1 | 4.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Myalgia, Dose 2 | 5.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Gastrointestinal symptoms, Dose 2 | 3.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Temperature, Dose 2 | 1.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Headache, Dose 1 | 2.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Shivering, Dose 1 | 2.0 Days |
| Placeb-PreChemo | Number of Days With Solicited General Symptoms | Headache, Dose 2 | 2.0 Days |
Primary
Number of Days With Solicited Local Symptoms
The number of days with any local symptoms has been assessed during the post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Days With Solicited Local Symptoms | Swelling, Dose 2 | 3.5 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited Local Symptoms | Redness, Dose 2 | 4.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited Local Symptoms | Swelling, Dose 1 | 4.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited Local Symptoms | Pain, Dose 1 | 2.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited Local Symptoms | Pain, Dose 2 | 2.0 Days |
| GSK1437173A-PreChemo | Number of Days With Solicited Local Symptoms | Redness, Dose 1 | 3.0 Days |
| Placeb-PreChemo | Number of Days With Solicited Local Symptoms | Pain, Dose 1 | 2.0 Days |
| Placeb-PreChemo | Number of Days With Solicited Local Symptoms | Swelling, Dose 1 | 7.0 Days |
| Placeb-PreChemo | Number of Days With Solicited Local Symptoms | Pain, Dose 2 | 1.0 Days |
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 83 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 8 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 33 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 15 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 52 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 4 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 20 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 90 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 11 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 40 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 18 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 2 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 5 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 7 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
Primary
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.
Time frame: From first vaccination up to 30 days post last vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMDs | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMDs | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Any pIMDs | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) | Related pIMDs | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal \[symptoms included nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and fever \[defined as oral, axillary or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 32 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 12 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 4 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 13 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 13 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 20 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 10 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 3 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 6 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 10 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 8 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 11 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 50 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 4 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 57 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 78 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 9 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 16 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 9 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 19 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 8 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 51 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 6 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 6 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 32 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 11 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 41 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 43 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 25 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 6 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 5 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 16 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 28 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 60 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 6 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 12 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 27 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 30 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 29 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 39 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 15 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 6 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 16 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 5 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 20 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 7 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 3 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 14 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 56 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 44 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 10 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 21 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 5 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 2 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 24 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 4 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 17 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 13 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 2 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 4 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 4 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 57 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 6 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 8 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 39 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 2 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 25 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 2 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 23 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 4 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 17 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 4 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 68 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 8 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 14 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 49 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 7 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 40 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 6 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 31 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 4 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 5 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 25 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 5 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 5 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
Primary
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.
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 study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 100 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 18 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 10 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 103 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 15 Participants |
| Placeb-PreChemo | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 9 Participants |
Primary
Number of Subjects With 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. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.
Time frame: From first dose up to 30 days post last vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs | 16 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs | 14 Participants |
| Placeb-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
Secondary
Anti-VZV gE Antibody Concentrations
Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.
Time frame: At Months 0, 1, 6 and 13
Population: The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 0 | 1049.8 mIU/mL |
| GSK1437173A-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 1 | 24793.1 mIU/mL |
| GSK1437173A-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 6 | 7730.4 mIU/mL |
| GSK1437173A-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 13 | 4477.3 mIU/mL |
| Placeb-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 13 | 1064.7 mIU/mL |
| Placeb-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 0 | 1116.7 mIU/mL |
| Placeb-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 6 | 1380.2 mIU/mL |
| Placeb-PreChemo | Anti-VZV gE Antibody Concentrations | Anti-VZV gE, Month 1 | 1107.2 mIU/mL |
Secondary
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups
Descriptive statistics were tabulated for CD4\[2+\] cells, which are gE specific CD4+ T-cells with at least two activation markers (\[2+\]), expressed from the activation markers interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40-ligand (CD40-L), as determined by intracellular cytokine staining (ICS) method.
Time frame: At Months 0, 1, 2 and 13
Population: The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 0 | 127.3 CD4 T-cells/million T-cells |
| GSK1437173A-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 1 | 391.9 CD4 T-cells/million T-cells |
| GSK1437173A-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 2 | 778.8 CD4 T-cells/million T-cells |
| GSK1437173A-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 13 | 332.9 CD4 T-cells/million T-cells |
| Placeb-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 13 | 51.2 CD4 T-cells/million T-cells |
| Placeb-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 0 | 104.8 CD4 T-cells/million T-cells |
| Placeb-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 2 | 61.8 CD4 T-cells/million T-cells |
| Placeb-PreChemo | Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 1 | 50.0 CD4 T-cells/million T-cells |
Secondary
Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From 30 days post last vaccination up to study end (Month 13)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs) | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs) | 1 Participants |
Secondary
Number of Subjects With Serious Adverse Events (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 = SAE assessed by the investigator as causally related to the study vaccination.
Time frame: From 30 days post last vaccination up to study end (Month 13)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs | 30 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Any SAEs | 31 Participants |
| Placeb-PreChemo | Number of Subjects With Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
Secondary
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations
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.
Time frame: At Months 1, 2, 6 and 13
Population: The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 1 | 73 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 2 | 75 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 6 | 31 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 13 | 35 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 13 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 6 | 1 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations | Vaccine responders Month 2 | 0 Participants |
Secondary
Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups
Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive 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 1, 2 and 13
Population: The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 1 | 5 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 2 | 11 Participants |
| GSK1437173A-PreChemo | Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 13 | 3 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 1 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 2 | 0 Participants |
| Placeb-PreChemo | Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups | CD4[2+] T-cells, Month 13 | 0 Participants |