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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01798056
• Collaborator: (none)
• Enrollment: 237
• Locations: 28
• Arms: 2
• Actual Duration (Months): 38.5
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster; Herpes Zoster Vaccine	Biological: GSK 1437173A; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 237 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Mar 6, 2013
• Actual Primary Completion Date: Jun 18, 2015
• Actual Study Completion Date: May 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: GSK 1437173A; 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.; Other Names: HZ/su GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine
Placebo Comparator: 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.	Drug: Placebo; 2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
2	GSK Investigational Site	Toronto	Ontario	Canada	M4C 3E7
3	GSK Investigational Site	Montreal	Quebec	Canada	H4J 1C5
4	GSK Investigational Site	Praha 8		Czechia	180 00
5	GSK Investigational Site	Besançon cedex		France	25030
6	GSK Investigational Site	Ferolles-Attilly		France	77150
7	GSK Investigational Site	Lyon Cedex 08		France	69373
8	GSK Investigational Site	Nîmes cedex 9		France	30029
9	GSK Investigational Site	Seoul		Korea, Republic of	02841
10	GSK Investigational Site	Seoul		Korea, Republic of	03080
11	GSK Investigational Site	Seoul		Korea, Republic of	05505
12	GSK Investigational Site	Badajoz		Spain	6080
13	GSK Investigational Site	Barcelona		Spain	08035
14	GSK Investigational Site	Madrid		Spain	28007
15	GSK Investigational Site	Madrid		Spain	28034
16	GSK Investigational Site	Madrid		Spain	28040
17	GSK Investigational Site	Madrid		Spain	28041
18	GSK Investigational Site	Madrid		Spain	28050
19	GSK Investigational Site	Majadahonda (Madrid)		Spain	28222
20	GSK Investigational Site	Móstoles		Spain	28935
21	GSK Investigational Site	Pozuelo De Alarcón/Madrid		Spain	28223
22	GSK Investigational Site	San Sebastian de los Reyes		Spain	28702
23	GSK Investigational Site	Cheltenham	Gloucestershire	United Kingdom	GL53 7AN
24	GSK Investigational Site	Woolwich	London	United Kingdom	SE18 4QH
25	GSK Investigational Site	Swindon	Wiltshire	United Kingdom	SN3 6BB
26	GSK Investigational Site	Exeter		United Kingdom	EX2 5DW
27	GSK Investigational Site	Sheffield		United Kingdom	S10 2SJ
28	GSK Investigational Site	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Full CSR posting on gsk.

Publications

• Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, López-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1. Erratum in: Cancer. 2020 Jun 15;126(12):2941.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01798056
• Other Study ID Numbers: 116427; 2012-002966-11
• First Posted: Feb 25, 2013
• Last Update Posted: May 13, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: ≥18 years of age; Chemotherapy; Solid tumours; Immunogenicity; Herpes Zoster; Safety; Shingles
• Additional relevant MeSH terms: Herpes Simplex; Herpes Zoster; Vaccines

Study Results

Participant Flow

Pre-assignment Detail	Out of the 237 subjects initially enrolled in the study, only 232 subject were included in the Total Vaccinated Cohort.

Arm/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Period Title: Overall Study
STARTED	117	115
COMPLETED	90	90
NOT COMPLETED	27	25

Baseline Characteristics

Arm/Group Title	GSK1437173A Group	Placebo Group	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	117	115	232
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.1 (10.8)	58.5 (11.7)	57.79 (11.25)
Sex: Female, Male (Count of Participants)
Female	70 59.8%	69 60%	139 59.9%
Male	47 40.2%	46 40%	93 40.1%
Race/Ethnicity, Customized (Count of Participants)
African Heritage/African American	2 1.7%	2 1.7%	4 1.7%
American Indian or Alaskan Native	2 1.7%	0 0%	2 0.9%
Asian - East Asian Heritage	11 9.4%	14 12.2%	25 10.8%
Asian - South East Asian Heritage	0 0%	2 1.7%	2 0.9%
White - Arabic/North African Heritage	1 0.9%	0 0%	1 0.4%
White - Caucasian/European Heritage	92 78.6%	88 76.5%	180 77.6%
Mixed Origin	0 0%	1 0.9%	1 0.4%
Missing	9 7.7%	8 7%	17 7.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A-PreChemo	Placeb-PreChemo
Arm/Group Description	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.	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.
Measure Participants	65	76
Geometric Mean (95% Confidence Interval) [EL.U/mL]	24501.57	1056.77

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK1437173A-PreChemo, Placeb-PreChemo
	Comments	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).
	Type of Statistical Test	Non-Inferiority
	Comments	Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	23.2
	Confidence Interval	(2-Sided) 95%; 17.9 to 30
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	87	98
Geometric Mean (95% Confidence Interval) [mIU/mL]	18291.7	1060.5

3. Primary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	112	110
Any Pain, Dose 1	83 70.9%	2 1.7%
Grade 3 Pain, Dose 1	8 6.8%	0 0%
Any Redness, Dose 1	33 28.2%	0 0%
Grade 3 Redness, Dose 1	2 1.7%	0 0%
Any Swelling, Dose 1	15 12.8%	1 0.9%
Grade 3 Swelling, Dose 1	0 0%	0 0%
Any Pain, Dose 2	52 44.4%	5 4.3%
Grade 3 Pain, Dose 2	4 3.4%	0 0%
Any Redness, Dose 2	20 17.1%	0 0%
Grade 3 Redness, Dose 2	0 0%	0 0%
Any Swelling, Dose 2	8 6.8%	0 0%
Grade 3 Swelling, Dose 2	0 0%	0 0%
Any Pain, Across doses	90 76.9%	7 6.1%
Grade 3 Pain, Across doses	11 9.4%	0 0%
Any Redness, Across doses	40 34.2%	0 0%
Grade 3 Redness, Across doses	2 1.7%	0 0%
Any Swelling, Across doses	18 15.4%	1 0.9%
Grade 3 Swelling, Across doses	0 0%	0 0%

4. Primary Outcome

Title	Number of Days With Solicited Local Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	112	110
Measure Doses with the symptom	83	5
Pain, Dose 1	2.0	2.0
Pain, Dose 2	2.0	1.0
Redness, Dose 1	3.0
Redness, Dose 2	4.0
Swelling, Dose 1	4.0	7.0
Swelling, Dose 2	3.5

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	112	110
Any Fatigue, Dose 1	56 47.9%	44 38.3%
Grade 3 Fatigue, Dose 1	10 8.5%	3 2.6%
Related Fatigue, Dose 1	15 12.8%	10 8.7%
Any Gastrointestinal, Dose 1	32 27.4%	21 18.3%
Grade 3 Gastrointestinal, Dose 1	2 1.7%	5 4.3%
Related Gastrointestinal, Dose 1	9 7.7%	2 1.7%
Any Headache, Dose 1	28 23.9%	24 20.9%
Grade 3 Headache, Dose 1	3 2.6%	1 0.9%
Related Headache, Dose 1	10 8.5%	4 3.5%
Any Myalgia, Dose 1	50 42.7%	17 14.8%
Grade 3 Myalgia, Dose 1	8 6.8%	3 2.6%
Related Myalgia, Dose 1	25 21.4%	3 2.6%
Any Shivering, Dose 1	27 23.1%	13 11.3%
Grade 3 Shivering, Dose 1	5 4.3%	2 1.7%
Related Shivering, Dose 1	12 10.3%	4 3.5%
Any Fever, Dose 1	13 11.1%	4 3.5%
Grade 3 Fever, Dose 1	0 0%	0 0%
Related Fever, Dose 1	11 9.4%	1 0.9%
Any Fatigue, Dose 2	57 48.7%	57 49.6%
Grade 3 Fatigue, Dose 2	9 7.7%	6 5.2%
Related Fatigue, Dose 2	6 5.1%	8 7%
Any Gastrointestinal, Dose 2	41 35%	39 33.9%
Grade 3 Gastrointestinal, Dose 2	5 4.3%	3 2.6%
Related Gastrointestinal, Dose 2	6 5.1%	2 1.7%
Any Headache, Dose 2	29 24.8%	25 21.7%
Grade 3 Headache, Dose 2	3 2.6%	2 1.7%
Related Headache, Dose 2	7 6%	2 1.7%
Any Myalgia, Dose 2	32 27.4%	23 20%
Grade 3 Myalgia, Dose 2	4 3.4%	1 0.9%
Related Myalgia, Dose 2	13 11.1%	4 3.5%
Any Shivering, Dose 2	20 17.1%	17 14.8%
Grade 3 Shivering, Dose 2	3 2.6%	1 0.9%
Related Shivering, Dose 2	6 5.1%	4 3.5%
Any Fever, Dose 2	8 6.8%	1 0.9%
Grade 3 Fever, Dose 2	0 0%	0 0%
Related Fever, Dose 2	4 3.4%	0 0%
Any Fatigue, Across doses	78 66.7%	68 59.1%
Grade 3 Fatigue, Across doses	16 13.7%	8 7%
Related Fatigue, Across doses	19 16.2%	14 12.2%
Any Gastrointestinal, Across doses	51 43.6%	49 42.6%
Grade 3 Gastrointestinal, Across doses	6 5.1%	7 6.1%
Related Gastrointestinal, Across doses	11 9.4%	3 2.6%
Any Headache, Across doses	43 36.8%	40 34.8%
Grade 3 Headache, Across doses	6 5.1%	3 2.6%
Related Headache, Across doses	16 13.7%	6 5.2%
Any Myalgia, Across doses	60 51.3%	31 27%
Grade 3 Myalgia, Across doses	12 10.3%	4 3.5%
Related Myalgia, Across doses	30 25.6%	5 4.3%
Any Shivering, Across doses	39 33.3%	25 21.7%
Grade 3 Shivering, Across doses	6 5.1%	3 2.6%
Related Shivering, Across doses	16 13.7%	5 4.3%
Any Temperature, Across doses	20 17.1%	5 4.3%
Grade 3 Temperature, Across doses	0 0%	0 0%
Related Temperature, Across doses	14 12%	1 0.9%

6. Primary Outcome

Title	Number of Days With Solicited General Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	112	110
Measure Doses with the symptom	57	57
Fatigue, Dose 1	3.0	5.0
Fatigue, Dose 2	5.0	5.0
Gastrointestinal symptoms, Dose 1	2.5	4.0
Gastrointestinal symptoms, Dose 2	4.0	3.0
Headache, Dose 1	2.0	2.0
Headache, Dose 2	2.0	2.0
Myalgia, Dose 1	2.5	2.0
Myalgia, Dose 2	3.0	5.0
Shivering, Dose 1	2.0	2.0
Shivering, Dose 2	3.0	2.0
Temperature, Dose 1	1.0	1.0
Temperature, Dose 2	1.5	1.0

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	117	115
Any AE(s)	100 85.5%	103 89.6%
Grade 3 AE(s)	18 15.4%	15 13%
Related AE(s)	10 8.5%	9 7.8%

8. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	117	115
Any SAEs	16 13.7%	14 12.2%
Related SAEs	0 0%	0 0%

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	117	115
Any pIMDs	0 0%	0 0%
Related pIMDs	0 0%	0 0%

10. Secondary Outcome

Title	Anti-VZV gE Antibody Concentrations
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	87	97
Anti-VZV gE, Month 0	1049.8	1116.7
Anti-VZV gE, Month 1	24793.1	1107.2
Anti-VZV gE, Month 6	7730.4	1380.2
Anti-VZV gE, Month 13	4477.3	1064.7

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	87	94
Vaccine responders Month 1	73 62.4%	0 0%
Vaccine responders Month 2	75 64.1%	0 0%
Vaccine responders Month 6	31 26.5%	1 0.9%
Vaccine responders Month 13	35 29.9%	0 0%

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A-PreChemo	Placeb-PreChemo
Arm/Group Description	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.	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.
Measure Participants	25	30
CD4[2+] T-cells, Month 0	127.3	104.8
CD4[2+] T-cells, Month 1	391.9	50.0
CD4[2+] T-cells, Month 2	778.8	61.8
CD4[2+] T-cells, Month 13	332.9	51.2

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	GSK1437173A-PreChemo	Placeb-PreChemo
Arm/Group Description	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.	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.
Measure Participants	25	27
CD4[2+] T-cells, Month 1	5 4.3%	0 0%
CD4[2+] T-cells, Month 2	11 9.4%	0 0%
CD4[2+] T-cells, Month 13	3 2.6%	0 0%

14. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	117	115
Any SAEs	30 25.6%	31 27%
Related SAEs	0 0%	0 0%

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK1437173A Group	Placebo Group
Arm/Group Description	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.
Measure Participants	117	115
Count of Participants [Participants]	0 0%	1 0.9%

Adverse Events

Time Frame	Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Arm/Group Title	GSK1437173A Group		Placebo Group
Arm/Group Description	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.
All Cause Mortality
	GSK1437173A Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/117 (10.3%)		11/115 (9.6%)
Serious Adverse Events
	GSK1437173A Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/117 (30.8%)		42/115 (36.5%)
Blood and lymphatic system disorders
Anaemia	2/117 (1.7%)	2	3/115 (2.6%)	3
Febrile neutropenia	6/117 (5.1%)	8	2/115 (1.7%)	3
Neutropenia	2/117 (1.7%)	2	4/115 (3.5%)	4
Pancytopenia	2/117 (1.7%)	2	0/115 (0%)	0
Thrombocytopenia	0/117 (0%)	0	2/115 (1.7%)	2
Cardiac disorders
Cardiac arrest	1/117 (0.9%)	1	0/115 (0%)	0
Cardiac failure	1/117 (0.9%)	1	0/115 (0%)	0
Cardiac failure congestive	0/117 (0%)	0	1/115 (0.9%)	1
Myocardial infarction	1/117 (0.9%)	1	0/115 (0%)	0
Endocrine disorders
Autoimmune thyroiditis	0/117 (0%)	0	1/115 (0.9%)	1
Gastrointestinal disorders
Constipation	0/117 (0%)	0	2/115 (1.7%)	2
Diarrhoea	1/117 (0.9%)	2	0/115 (0%)	0
Dysphagia	1/117 (0.9%)	1	0/115 (0%)	0
Enteritis	0/117 (0%)	0	1/115 (0.9%)	1
Mouth ulceration	1/117 (0.9%)	1	0/115 (0%)	0
Nausea	1/117 (0.9%)	1	0/115 (0%)	0
Odynophagia	1/117 (0.9%)	1	0/115 (0%)	0
Oesophagitis	1/117 (0.9%)	1	0/115 (0%)	0
General disorders
Death	1/117 (0.9%)	1	0/115 (0%)	0
Mucosal inflammation	2/117 (1.7%)	2	0/115 (0%)	0
Pyrexia	1/117 (0.9%)	2	1/115 (0.9%)	1
Hepatobiliary disorders
Cholangitis acute	1/117 (0.9%)	1	0/115 (0%)	0
Immune system disorders
Drug hypersensitivity	0/117 (0%)	0	1/115 (0.9%)	1
Infections and infestations
Anal abscess	0/117 (0%)	0	1/115 (0.9%)	1
Bacteraemia	1/117 (0.9%)	1	0/115 (0%)	0
Candida infection	1/117 (0.9%)	1	0/115 (0%)	0
Clostridium bacteraemia	0/117 (0%)	0	1/115 (0.9%)	1
Clostridium difficile infection	1/117 (0.9%)	2	0/115 (0%)	0
Device related sepsis	1/117 (0.9%)	1	0/115 (0%)	0
Diverticulitis	1/117 (0.9%)	1	0/115 (0%)	0
Epiglottitis	1/117 (0.9%)	1	0/115 (0%)	0
Gastroenteritis	2/117 (1.7%)	2	0/115 (0%)	0
Hepatitis c	0/117 (0%)	0	1/115 (0.9%)	1
Infected dermal cyst	0/117 (0%)	0	1/115 (0.9%)	1
Kidney infection	0/117 (0%)	0	1/115 (0.9%)	1
Lower respiratory tract infection	1/117 (0.9%)	1	0/115 (0%)	0
Lung infection	0/117 (0%)	0	1/115 (0.9%)	1
Nasopharyngitis	1/117 (0.9%)	1	0/115 (0%)	0
Neutropenic sepsis	1/117 (0.9%)	1	2/115 (1.7%)	3
Oral candidiasis	1/117 (0.9%)	1	0/115 (0%)	0
Pleural infection	1/117 (0.9%)	1	0/115 (0%)	0
Pneumonia	1/117 (0.9%)	1	2/115 (1.7%)	2
Respiratory tract infection	2/117 (1.7%)	2	1/115 (0.9%)	1
Sepsis	3/117 (2.6%)	3	2/115 (1.7%)	2
Staphylococcal infection	0/117 (0%)	0	1/115 (0.9%)	1
Upper respiratory tract infection	0/117 (0%)	0	1/115 (0.9%)	1
Urinary tract infection	1/117 (0.9%)	1	0/115 (0%)	0
Urosepsis	0/117 (0%)	0	1/115 (0.9%)	1
Injury, poisoning and procedural complications
Gastrostomy failure	1/117 (0.9%)	1	0/115 (0%)	0
Lumbar vertebral fracture	0/117 (0%)	0	1/115 (0.9%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	2/117 (1.7%)	2	0/115 (0%)	0
Hypokalaemia	1/117 (0.9%)	1	0/115 (0%)	0
Hyponatraemia	1/117 (0.9%)	1	0/115 (0%)	0
Malnutrition	2/117 (1.7%)	2	0/115 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/117 (0%)	0	1/115 (0.9%)	1
Musculoskeletal chest pain	0/117 (0%)	0	1/115 (0.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	1/117 (0.9%)	1	0/115 (0%)	0
Bladder cancer	2/117 (1.7%)	2	0/115 (0%)	0
Breast cancer recurrent	1/117 (0.9%)	2	0/115 (0%)	0
Cholangiocarcinoma	1/117 (0.9%)	1	0/115 (0%)	0
Colon cancer	0/117 (0%)	0	1/115 (0.9%)	1
Colorectal cancer	1/117 (0.9%)	1	0/115 (0%)	0
Colorectal cancer metastatic	0/117 (0%)	0	1/115 (0.9%)	1
Head and neck cancer	0/117 (0%)	0	1/115 (0.9%)	1
Liposarcoma	0/117 (0%)	0	1/115 (0.9%)	1
Lung neoplasm malignant	1/117 (0.9%)	1	1/115 (0.9%)	1
Malignant melanoma	0/117 (0%)	0	1/115 (0.9%)	1
Metastases to central nervous system	1/117 (0.9%)	1	0/115 (0%)	0
Metastases to liver	1/117 (0.9%)	1	0/115 (0%)	0
Non-small cell lung cancer	0/117 (0%)	0	1/115 (0.9%)	1
Ovarian cancer	0/117 (0%)	0	1/115 (0.9%)	1
Prostate cancer	1/117 (0.9%)	1	1/115 (0.9%)	1
Rectal cancer metastatic	0/117 (0%)	0	1/115 (0.9%)	1
Squamous cell carcinoma of lung	1/117 (0.9%)	1	0/115 (0%)	0
Tongue neoplasm malignant stage unspecified	0/117 (0%)	0	1/115 (0.9%)	1
Tumour haemorrhage	1/117 (0.9%)	1	0/115 (0%)	0
Uterine leiomyosarcoma	0/117 (0%)	0	1/115 (0.9%)	1
Nervous system disorders
Hepatic encephalopathy	1/117 (0.9%)	1	0/115 (0%)	0
Seizure	1/117 (0.9%)	1	1/115 (0.9%)	1
Renal and urinary disorders
Acute kidney injury	1/117 (0.9%)	1	2/115 (1.7%)	2
Hydronephrosis	0/117 (0%)	0	1/115 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction	0/117 (0%)	0	1/115 (0.9%)	1
Pleural effusion	1/117 (0.9%)	1	2/115 (1.7%)	2
Pulmonary embolism	1/117 (0.9%)	1	2/115 (1.7%)	2
Respiratory failure	1/117 (0.9%)	2	0/115 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/117 (0%)	0	1/115 (0.9%)	1
Skin haemorrhage	0/117 (0%)	0	1/115 (0.9%)	1
Surgical and medical procedures
Abdominal hernia repair	0/117 (0%)	0	1/115 (0.9%)	1
Vascular disorders
Superior vena cava occlusion	0/117 (0%)	0	1/115 (0.9%)	1
Thrombosis	1/117 (0.9%)	1	0/115 (0%)	0
Other (Not Including Serious) Adverse Events
	GSK1437173A Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	113/117 (96.6%)		103/115 (89.6%)
Blood and lymphatic system disorders
Neutropenia	11/117 (9.4%)	12	14/115 (12.2%)	16
Gastrointestinal disorders
Constipation	16/117 (13.7%)	19	11/115 (9.6%)	11
Diarrhoea	9/117 (7.7%)	12	10/115 (8.7%)	10
Dyspepsia	6/117 (5.1%)	6	13/115 (11.3%)	13
Gastrointestinal disorder	51/117 (43.6%)	74	51/115 (44.3%)	63
Nausea	31/117 (26.5%)	36	28/115 (24.3%)	33
Vomiting	10/117 (8.5%)	10	14/115 (12.2%)	16
General disorders
Asthenia	30/117 (25.6%)	34	28/115 (24.3%)	32
Chills	39/117 (33.3%)	48	25/115 (21.7%)	30
Fatigue	80/117 (68.4%)	118	69/115 (60%)	109
Mucosal inflammation	9/117 (7.7%)	11	6/115 (5.2%)	8
Pain	90/117 (76.9%)	139	7/115 (6.1%)	7
Pyrexia	22/117 (18.8%)	23	9/115 (7.8%)	9
Swelling	18/117 (15.4%)	23	1/115 (0.9%)	1
Metabolism and nutrition disorders
Decreased appetite	9/117 (7.7%)	12	5/115 (4.3%)	5
Musculoskeletal and connective tissue disorders
Myalgia	62/117 (53%)	88	33/115 (28.7%)	45
Nervous system disorders
Dysgeusia	1/117 (0.9%)	1	6/115 (5.2%)	6
Headache	45/117 (38.5%)	61	41/115 (35.7%)	52
Skin and subcutaneous tissue disorders
Alopecia	21/117 (17.9%)	21	23/115 (20%)	23
Erythema	43/117 (36.8%)	58	1/115 (0.9%)	1

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.