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Vaccines

Immunologic Factors

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.

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.

2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

GSK 1437173A

2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Placebo

GSK Clinical Trials

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.

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy

An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy

IPD for this study will be made available via the Clinical Study Data Request site.

Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.

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.

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.

The number of days with any local symptoms has been assessed during the post-vaccination period.

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.

The number of days with any general symptoms has been assessed during the 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.

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.

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.

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 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.

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.

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.

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.

GlaxoSmithKline

GSK1437173A Group

Placebo Group

Total

Age, Continuous

Sex: Female, Male

Geographic ancestry

Race/Ethnicity, Customized

GSK Response Center

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).

Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. 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.

GSK1437173A-PreChemo

Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. 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.

Placeb-PreChemo

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.

Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups

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.

Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations

Any Pain, Dose 1

Grade 3 Pain, Dose 1

Any Redness, Dose 1

Grade 3 Redness, Dose 1

Any Swelling, Dose 1

Grade 3 Swelling, Dose 1

Any Pain, Dose 2

Grade 3 Pain, Dose 2

Any Redness, Dose 2

Grade 3 Redness, Dose 2

Any Swelling, Dose 2

Grade 3 Swelling, Dose 2

Any Pain, Across doses

Grade 3 Pain, Across doses

Any Redness, Across doses

Grade 3 Redness, Across doses

Any Swelling, Across doses

Grade 3 Swelling, Across doses

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.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Pain, Dose 1

Pain, Dose 2

Redness, Dose 1

Redness, Dose 2

Swelling, Dose 1

Swelling, Dose 2

Number of Days With Solicited Local Symptoms

Any Fatigue, Dose 1

Grade 3 Fatigue, Dose 1

Related Fatigue, Dose 1

Any Gastrointestinal, Dose 1

Grade 3 Gastrointestinal, Dose 1

Related Gastrointestinal, Dose 1

Any Headache, Dose 1

Grade 3 Headache, Dose 1

Related Headache, Dose 1

Any Myalgia, Dose 1

Grade 3 Myalgia, Dose 1

Related Myalgia, Dose 1

Any Shivering, Dose 1

Grade 3 Shivering, Dose 1

Related Shivering, Dose 1

Any Fever, Dose 1

Grade 3 Fever, Dose 1

Related Fever, Dose 1

Any Fatigue, Dose 2

Grade 3 Fatigue, Dose 2

Related Fatigue, Dose 2

Any Gastrointestinal, Dose 2

Grade 3 Gastrointestinal, Dose 2

Related Gastrointestinal, Dose 2

Any Headache, Dose 2

Grade 3 Headache, Dose 2

Related Headache, Dose 2

Any Myalgia, Dose 2

Grade 3 Myalgia, Dose 2

Related Myalgia, Dose 2

Any Shivering, Dose 2

Grade 3 Shivering, Dose 2

Related Shivering, Dose 2

Any Fever, Dose 2

Grade 3 Fever, Dose 2

Related Fever, Dose 2

Any Fatigue, Across doses

Grade 3 Fatigue, Across doses

Related Fatigue, Across doses

Any Gastrointestinal, Across doses

Grade 3 Gastrointestinal, Across doses

Related Gastrointestinal, Across doses

Any Headache, Across doses

Grade 3 Headache, Across doses

Related Headache, Across doses

Any Myalgia, Across doses

Grade 3 Myalgia, Across doses

Related Myalgia, Across doses

Any Shivering, Across doses

Grade 3 Shivering, Across doses

Related Shivering, Across doses

Any Temperature, Across doses

Grade 3 Temperature, Across doses

Related Temperature, Across doses

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Fatigue, Dose 1

Fatigue, Dose 2

Gastrointestinal symptoms, Dose 1

Gastrointestinal symptoms, Dose 2

Headache, Dose 1

Headache, Dose 2

Myalgia, Dose 1

Myalgia, Dose 2

Shivering, Dose 1

Shivering, Dose 2

Temperature, Dose 1

Temperature, Dose 2

Number of Days With Solicited General Symptoms

Any AE(s)

Grade 3 AE(s)

Related AE(s)

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Any SAEs

Related SAEs

Number of Subjects With Serious Adverse Events (SAEs)

Any pIMDs

Related pIMDs

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered

Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

Anti-VZV gE, Month 0

Anti-VZV gE, Month 1

Anti-VZV gE, Month 6

Anti-VZV gE, Month 13

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.

Anti-VZV gE Antibody Concentrations

Vaccine responders Month 1

Vaccine responders Month 2

Vaccine responders Month 6

Vaccine responders Month 13

Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations

CD4[2+] T-cells, Month 0

CD4[2+] T-cells, Month 1

CD4[2+] T-cells, Month 2

CD4[2+] T-cells, Month 13

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.

Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups

Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups

Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)

Overall Study

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