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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
237
2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.
GSK Investigational Site
Halifax, Nova Scotia, Canada
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
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
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
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
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.
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GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Besançon, France
GSK Investigational Site
Férolles-Attilly, France
GSK Investigational Site
Lyon, France
GSK Investigational Site
Nîmes, France
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
...and 18 more locations
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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
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
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
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
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
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
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
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
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)
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)