Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00434577
• Collaborator: (none)
• Enrollment: 715
• Locations: 11
• Arms: 5
• Actual Duration (Months): 40.9
• Patients Per Site: 65
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster	Biological: Herpes Zoster vaccine GSK1437173A Low Dose; Biological: Herpes Zoster vaccine GSK1437173A Medium Dose; Biological: Herpes Zoster vaccine GSK1437173A High Dose; Biological: Herpes Zoster vaccine GSK1437173A Modified; Biological: Placebo	Phase 2

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Design

• Study Type: Interventional
• Actual Enrollment: 715 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.
• Actual Study Start Date: Feb 14, 2007
• Actual Primary Completion Date: Oct 4, 2007
• Actual Study Completion Date: Jul 14, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK1437173A _LD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Biological: Herpes Zoster vaccine GSK1437173A Low Dose; Single or two-dose intramuscular injection.
Experimental: GSK1437173A _MD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Biological: Herpes Zoster vaccine GSK1437173A Medium Dose; Single or two-dose intramuscular injection.
Experimental: GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Biological: Herpes Zoster vaccine GSK1437173A High Dose; Single or two-dose intramuscular injection.
Placebo Comparator: Placebo + GSK1437173A _HD Group Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Biological: Herpes Zoster vaccine GSK1437173A High Dose; Single or two-dose intramuscular injection.; Biological: Placebo; Single intramuscular injection
Active Comparator: GSK1437173A_MODIFIED GROUP Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Biological: Herpes Zoster vaccine GSK1437173A Modified; Single or two-dose intramuscular injection.

Outcome Measures

Primary Outcome Measures

1. Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers [One month after the second vaccination (Month 3)]

   Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥).

2. Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers [One month after the second vaccination (Month 3)]

   Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level.

3. Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers [One month after the second vaccination (Month 3)]

   Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old.

Secondary Outcome Measures

1. Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old.

2. Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

3. Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

4. Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

5. Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

6. Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

7. Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

8. Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

9. Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

   Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

10. Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).

11. Anti-gE Specific Antibody Concentrations [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

12. Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations [At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)]

    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA.

13. Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers [At Months 12, 24 and 36]

    Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

14. Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker [At Months 12, 24 and 36]

    Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

15. Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker [At Months 12, 24 and 36]

    Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

16. Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker [At Month 12, 24 and 36]

    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

17. Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker [At Month 12, 24 and 36]

    Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.

18. Anti-gE Specific Antibody Concentrations [At Months 12, 24 and 36]

    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

19. Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations [At Months 12, 24 and 36]

    Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

20. Frequency of VZV-specific Memory B-cells in a Subset of Subjects [At pre-vaccination (Day 0) and at Month 3]

    Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older.

21. Number of Subjects With Different Biochemical and Haematological Levels [At Day 0, Month 2 and Month 3]

    Among biochemical and haematological parameters assessed were albumin [ALB], alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], calcium [CAL], eosinophils [EOS], fibrinogen [FIB], haematocrit [HEM], hemoglobin [Hgb], leucocytes [LEU], lymphocytes [LYM], lactate dehydrogenate [LDH], monocytes [MON], neutrophils [NEU], partial thromboplastin time [PTPT], platelets [PLA], pro thrombin time [PTT], red blood cells [RBC], serum creatinine [SCREA], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.

22. Number of German Subjects With Different Biochemical and Haematological Levels [At one week post-vaccination 1 (Month 0)]

    Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.

23. Number of German Subjects With Different Biochemical and Haematological Levels [At one week post-vaccination 2 (Month 2)]

    Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.

24. 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 activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

25. 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 arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. 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.

26. Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes [From Month 0 to Month 3]

    Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.

27. Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes [From Month 3 up to Month 36]

    Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.

28. 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.

29. Number of Subjects With Serious Adverse Events (SAEs) [From Month 0 to Month 3]

    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.

30. Number of Subjects With Serious Adverse Events (SAEs) [From Month 3 to Month 12]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• A male or female aged 60 years or older at the time of the first vaccination.

• Written informed consent obtained from the subject

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.

• Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.

• Previous vaccination against HZ.

• History of herpes zoster (Shingles).

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Acute disease at the time of enrolment.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.

• History of or current drug and/or alcohol abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Hradec Kralove		Czechia	500 01
2	GSK Investigational Site	Mannheim	Baden-Wuerttemberg	Germany	68161
3	GSK Investigational Site	Wuerzburg	Bayern	Germany	97070
4	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
5	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45359
6	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	51069
7	GSK Investigational Site	Berlin		Germany	13347
8	GSK Investigational Site	Amsterdam		Netherlands	1018 WT
9	GSK Investigational Site	Rotterdam		Netherlands	3011 EN
10	GSK Investigational Site	Eskilstuna		Sweden	SE-631 88
11	GSK Investigational Site	Uppsala		Sweden	SE-751 85

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JA, Richardus JH, Plassmann G, Schwarz TF, Ledent E, Heineman TC. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014 Mar 26;32(15):1745-53. doi: 10.1016/j.vaccine.2014.01.019. Epub 2014 Feb 6.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00434577
• Other Study ID Numbers: 108494; 108516; 108518; 108520; 2006-004863-69
• First Posted: Feb 13, 2007
• Last Update Posted: Mar 15, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: GSK Biologicals; Herpes Zoster (HZ); Vaccine; Varicella Zoster Virus (VZV); Shingles
• Additional relevant MeSH terms: Herpes Zoster; Vaccines

Study Results

Participant Flow

Pre-assignment Detail	Out of 715 subjects enrolled, only 714 were vaccinated.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Period Title: Months 0-3
STARTED	164	166	165	165	54
COMPLETED	161	164	161	164	51
NOT COMPLETED	3	2	4	1	3
Period Title: Months 0-3
STARTED	156	159	159	161	50
COMPLETED	156	159	159	161	50
NOT COMPLETED	0	0	0	0	0
Period Title: Months 0-3
STARTED	150	155	154	157	49
COMPLETED	150	155	154	157	49
NOT COMPLETED	0	0	0	0	0
Period Title: Months 0-3
STARTED	147	147	150	155	47
COMPLETED	147	147	150	155	47
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED GROUP	Total
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Total of all reporting groups
Overall Participants	164	166	165	165	54	714
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	72.8 (5.5)	72.9 (5.1)	73.0 (5.7)	73.1 (5.9)	72.1 (5.2)	72.9 (5.5)
Sex: Female, Male (Count of Participants)
Female	88 53.7%	100 60.2%	85 51.5%	95 57.6%	36 66.7%	404 56.6%
Male	76 46.3%	66 39.8%	80 48.5%	70 42.4%	18 33.3%	310 43.4%
Race/Ethnicity, Customized (Count of Participants)
African Heritage/African American	0 0%	1 0.6%	0 0%	0 0%	0 0%	1 0.1%
Asian - Central/South Asian Heritage	0 0%	1 0.6%	0 0%	0 0%	0 0%	1 0.1%
White - Arabic/North African Heritage	1 0.6%	1 0.6%	1 0.6%	0 0%	0 0%	3 0.4%
White - Caucasian/European Heritage	162 98.8%	163 98.2%	164 99.4%	165 100%	54 100%	708 99.2%
Other	1 0.6%	0 0%	0 0%	0 0%	0 0%	1 0.1%

Outcome Measures

1. Primary Outcome

Title	Frequency of Glycoprotein E (gE)-Specific Cluster of Differentiation (CD4) T-cells Expressing at Least Two Different Activation Markers
Description	Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects aged 70 or higher (≥).
Time Frame	One month after the second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol(ATP) cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	119	120	117	118	36
Median (Inter-Quartile Range) [T-cells/million cells]	1801.23	1722.83	1778.48	491.03	388.49

2. Primary Outcome

Title	Frequency Odds Ratio of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers
Description	Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old. The odds-ratios are calculated using the the frequency of CD4 secreting cytokines, upon in vitro stimulation with the specific antigen, at the numerator and the frequency of the CD4 secreting cytokines with the medium only (background level) at the denominator. The odds-ratios represent the fold-change in the specific response compared to the background level.
Time Frame	One month after the second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	119	120	117	118	36
Mean (Standard Deviation) [Fold Change]	12.83 (13.13)	15.00 (15.86)	21.53 (71.96)	5.92 (9.56)	4.05 (3.20)

3. Primary Outcome

Title	Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers
Description	Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects ≥ 70 years old.
Time Frame	One month after the second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	119	120	117	118	36
Mean (Standard Deviation) [T-cells/million cells]	2269.84 (1934.55)	2441.95 (2055.11)	2449.90 (1808.00)	681.73 (665.17)	512.55 (463.35)

4. Secondary Outcome

Title	Frequency of gE-specific CD4 T-cells Expressing at Least Two Different Activation Markers
Description	Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS) in subjects 60 to 69 years (60-69y) and ≥ 70 years (+70y) old.
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	152	150	144	150	48
CD4-All Doubles, Day 0	194.47 (214.96)	225.47 (370.67)	201.17 (230.96)	203.70 (221.97)	145.95 (164.57)
CD4-All Doubles, Month 2	459.01 (401.25)	482.84 (425.73)	489.45 (423.52)	173.91 (181.86)	230.28 (250.70)
CD4-All Double, Month 3	2246.29 (1976.42)	2372.07 (1877.43)	2569.29 (2052.74)	670.80 (606.93)	550.11 (448.15)

5. Secondary Outcome

Title	Frequency of gE-specific CD4 T-cells Expressing IFN-γ and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	151	150	144	148	48
Day 0	156.54 (199.12)	169.01 (326.34)	152.28 (220.50)	157.13 (180.00)	118.35 (125.08)
Month 2	279.39 (343.61)	279.20 (336.29)	292.15 (345.65)	124.05 (151.42)	168.34 (213.83)
Month 3	1179.29 (1021.14)	1296.04 (1132.18)	1417.40 (1303.60)	363.23 (364.74)	341.36 (313.79)

6. Secondary Outcome

Title	Frequency of gE-specific CD4 T-cells Expressing IL-2 and at Least Another Activation Marker
Description	Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	152	150	144	150	48
Day 0	171.21 (208.49)	191.28 (307.40)	180.85 (193.48)	172.41 (184.32)	125.22 (134.81)
Month 2	416.12 (369.85)	442.17 (363.10)	438.27 (378.81)	150.47 (160.29)	199.34 (224.39)
Month 3	2077.06 (1860.40)	2156.40 (1697.78)	2315.84 (1847.24)	597.76 (531.07)	491.06 (396.39)

7. Secondary Outcome

Title	Frequency of gE-specific CD4 T-cells Expressing TNF-α and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	152	150	144	150	48
Day 0	97.28 (137.06)	121.05 (296.79)	116.91 (173.65)	110.66 (162.02)	81.40 (107.44)
Month 2	251.94 (277.71)	256.15 (304.91)	263.39 (284.96)	95.84 (125.15)	120.73 (148.24)
Month 3	1317.39 (1304.53)	1282.96 (1183.69)	1389.62 (1231.76)	350.23 (380.60)	252.86 (253.55)

8. Secondary Outcome

Title	Frequency of gE-specific CD4 T-cells Expressing CD40L and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	152	150	144	149	48
Day 0	142.88 (169.52)	153.80 (214.95)	151.37 (160.38)	155.90 (187.47)	111.55 (126.92)
Month 2	385.34 (348.25)	405.95 (359.46)	417.20 (361.59)	132.62 (144.06)	182.82 (195.36)
Month 3	2014.37 (1849.25)	2154.81 (1799.64)	2303.13 (1987.94)	567.33 (566.48)	433.56 (391.64)

9. Secondary Outcome

Title	Frequency of gE-specific CD8 T-cells Expressing at Least Two Different Activation Markers
Description	Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	126	120	118	119	39
CD8-All Doubles, Day 0	74.62 (118.02)	98.88 (164.52)	122.37 (221.20)	80.54 (121.84)	108.21 (330.11)
CD8-All Doubles, Month 2	85.29 (139.32)	106.23 (141.63)	86.35 (168.10)	120.06 (221.20)	98.97 (299.34)
CD8-All Doubles, Month 3	96.43 (155.37)	88.77 (140.95)	117.70 (196.09)	112.99 (165.52)	116.41 (450.85)

10. Secondary Outcome

Title	Frequency of gE-specific CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	98	91	98	95	32
Day 0	60.35 (97.12)	75.79 (114.55)	106.39 (199.96)	70.69 (121.23)	123.99 (360.75)
Month 2	65.97 (111.02)	106.74 (133.15)	72.58 (92.99)	106.02 (184.40)	95.05 (326.45)
Month 3	88.62 (136.13)	76.92 (123.74)	95.01 (138.77)	96.91 (161.10)	125.69 (480.05)

11. Secondary Outcome

Title	Frequency of gE-specific CD8 T-cells Expressing IL-2 and at Least Another Activation Marker
Description	Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	97	91	88	90	27
Day 0	81.42 (108.62)	83.13 (131.07)	90.71 (140.18)	63.56 (89.18)	43.03 (58.88)
Month 2	61.05 (106.36)	78.18 (92.65)	83.07 (186.88)	82.47 (126.08)	68.98 (85.29)
Month 3	69.06 (97.12)	65.08 (83.71)	103.17 (179.57)	82.95 (99.47)	56.42 (120.85)

12. Secondary Outcome

Title	Frequency of gE-specific CD8 T-cells Expressing TNF-α and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	100	102	108	97	33
Day 0	74.94 (113.07)	87.33 (117.28)	111.54 (204.36)	81.54 (119.17)	122.68 (362.64)
Month 2	71.42 (96.41)	83.01 (124.50)	75.88 (129.33)	111.15 (217.08)	115.82 (356.29)
Month 3	86.81 (120.39)	76.75 (137.37)	99.07 (139.42)	106.97 (167.59)	136.22 (470.58)

13. Secondary Outcome

Title	Frequency of gE-specific CD8 T-cells Expressing CD40L and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	78	70	77	76	25
Day 0	41.35 (54.48)	61.30 (118.43)	56.85 (78.31)	35.96 (69.51)	59.94 (75.13)
Month 2	63.87 (82.02)	66.76 (90.29)	47.20 (64.54)	71.20 (93.18)	54.63 (69.92)
Month 3	69.50 (105.36)	65.34 (64.17)	85.57 (105.34)	76.19 (72.44)	33.12 (47.32)

14. Secondary Outcome

Title	Anti-gE Specific Antibody Concentrations
Description	Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	157	156	151	153	50
Anti-gE, Day 0	351.6	312.8	416.1	337.2	323.7
Anti-gE, Month 2	3667.6	4139.4	5485.6	361.5	2148.9
Anti-gE, Month 3	9315.3	12898.0	15626.5	6287.2	4298.3

15. Secondary Outcome

Title	Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations
Description	Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), as assessed by ELISA.
Time Frame	At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	157	156	151	153	50
Anti-VZV, Day 0	1334.9	1212.0	1510.7	1356.3	1422.5
Anti-VZV, Month 2	4408.1	5131.9	6511.7	1341.6	3481.2
Anti-VZV, Month 3	8821.6	11451.0	14143.5	6432.2	5357.6

16. Secondary Outcome

Title	Frequency of gE-specific CD4/CD8 T-cells Expressing at Least Two Different Activation Markers
Description	Among the activation markers expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time Frame	At Months 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	150	148	151	151	45
CD4-All Doubles, Month 12	1135.8 (936.0)	1275.5 (1195.4)	1274.0 (995.0)	340.4 (296.8)	274.5 (217.3)
CD4-All Doubles, Month 24	1004.1 (838.8)	1195.5 (1375.5)	1079.9 (948.0)	244.1 (233.2)	285.2 (255.6)
CD4-All Doubles, Month 36	827.3 (922.9)	969.7 (1034.9)	896.3 (770.4)	239.7 (181.7)	229.7 (217.1)

17. Secondary Outcome

Title	Frequency of gE-specific CD4/CD8 T-cells Expressing IFN-γ and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time Frame	At Months 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	150	148	151	151	45
Month 12	659.9 (594.3)	767.8 (895.1)	718.9 (634.2)	235.5 (244.7)	176.8 (152.7)
Month 24	541.9 (503.1)	668.9 (1140.6)	543.6 (554.7)	157.0 (183.4)	181.2 (158.4)
Month 36	491.8 (604.1)	583.3 (819.0)	492.3 (437.0)	172.2 (155.1)	162.0 (151.4)

18. Secondary Outcome

Title	Frequency of gE-specific CD4/CD8 T-cells Expressing IL-2 and at Least Another Activation Marker
Description	Among other activation markers expressed were interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time Frame	At Months 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	150	148	151	151	45
Month 12	1056.2 (901.0)	1164.7 (1029.1)	1168.3 (935.4)	291.7 (266.6)	243.9 (204.8)
Month 24	943.0 (809.5)	1100.2 (1158.9)	1007.8 (909.5)	213.0 (207.4)	233.0 (244.5)
Month 36	768.9 (871.5)	890.2 (883.3)	834.7 (743.9)	205.8 (154.5)	213.9 (202.2)

19. Secondary Outcome

Title	Frequency of gE-specific CD4/CD8 T-cells Expressing TNFα and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	150	148	151	151	45
Month 12	673.7 (616.0)	736.2 (878.5)	736.7 (660.7)	193.2 (239.4)	136.0 (132.8)
Month 24	567.9 (527.7)	663.1 (1097.0)	591.5 (586.6)	144.1 (196.1)	133.0 (158.1)
Month 36	497.4 (652.5)	567.9 (808.4)	510.7 (522.1)	117.9 (151.7)	98.1 (116.0)

20. Secondary Outcome

Title	Frequency of gE-specific CD4/CD8 T-cells Expressing CD40L and at Least Another Activation Marker
Description	Among other activation markers expressed were interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α] . Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS). Month 12, 24 and 36 CMI analyses on CD8+ T cells were not performed as no detectable CD8 T+ cell response was measured to any of the vaccine formulations in the primary (108494) study.
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	150	148	151	151	45
Month 12	969.0 (811.8)	1057.2 (943.4)	1062.8 (850.3)	267.5 (246.0)	221.0 (180.9)
Month 24	935.2 (801.5)	1079.9 (1040.1)	981.6 (890.9)	210.8 (187.2)	270.3 (248.6)
Month 36	753.0 (852.9)	912.9 (1009.2)	823.0 (727.9)	202.5 (166.3)	202.8 (187.1)

21. Secondary Outcome

Title	Anti-gE Specific Antibody Concentrations
Description	Concentrations were presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	At Months 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	156	159	159	160	50
Anti-gE, Month 12	3384.8	4280.3	5258.2	1664.5	1888.2
Anti-gE, Month 24	2363.8	2784.6	3390.0	1126.3	1339.1
Anti-gE, Month 36	2064.1	2444.3	2956.4	959.5	973.9

22. Secondary Outcome

Title	Anti-varicella Zoster Virus (VZV) Specific Antibody Concentrations
Description	Concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time Frame	At Months 12, 24 and 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36 respectively.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	149	155	154	157	48
Anti-VZV, Month 12	4190.1	4761.3	5559.1	2704.1	2733.8
Anti-VZV, Month 24	2557.4	2673.6	2976.0	1849.3	1922.6
Anti-VZV, Month 36	2426.6	2555.0	2826.7	1729.9	1739.9

23. Secondary Outcome

Title	Frequency of VZV-specific Memory B-cells in a Subset of Subjects
Description	Memory B cells specific to the gE antigen, as assessed by the enzyme-linked immunosorbent spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Results were tabulated for subjects aged 70 years and older.
Time Frame	At pre-vaccination (Day 0) and at Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Month 12, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Month 12.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	19	23	23	21	8
Memory B-cells, Day 0	336.5 (359.5)	490.4 (704.7)	356.6 (348.0)	332.3 (404.9)	380.6 (299.7)
Memory B-cells, Month 3	5699.3 (8166.2)	5997.1 (5034.6)	9707.5 (8787.1)	1583.7 (2266.0)	1042.2 (1139.9)

24. Secondary Outcome

Title	Number of Subjects With Different Biochemical and Haematological Levels
Description	Among biochemical and haematological parameters assessed were albumin [ALB], alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], calcium [CAL], eosinophils [EOS], fibrinogen [FIB], haematocrit [HEM], hemoglobin [Hgb], leucocytes [LEU], lymphocytes [LYM], lactate dehydrogenate [LDH], monocytes [MON], neutrophils [NEU], partial thromboplastin time [PTPT], platelets [PLA], pro thrombin time [PTT], red blood cells [RBC], serum creatinine [SCREA], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
Time Frame	At Day 0, Month 2 and Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	164	166	164	165	54
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	13 7.9%	12 7.2%	14 8.5%	12 7.3%	4 7.4%
Within	57 34.8%	64 38.6%	59 35.8%	61 37%	19 35.2%
Above	4 2.4%	1 0.6%	2 1.2%	2 1.2%	1 1.9%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	13 7.9%	14 8.4%	11 6.7%	17 10.3%	6 11.1%
Within	57 34.8%	61 36.7%	62 37.6%	55 33.3%	16 29.6%
Above	2 1.2%	2 1.2%	1 0.6%	3 1.8%	0 0%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	8 4.9%	12 7.2%	9 5.5%	17 10.3%	4 7.4%
Within	61 37.2%	62 37.3%	61 37%	55 33.3%	17 31.5%
Above	1 0.6%	3 1.8%	2 1.2%	3 1.8%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	1 1.9%
Below	1 0.6%	2 1.2%	0 0%	1 0.6%	0 0%
Within	150 91.5%	151 91%	152 92.1%	154 93.3%	50 92.6%
Above	13 7.9%	13 7.8%	12 7.3%	10 6.1%	3 5.6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	1 0.6%	1 0.6%	0 0%	1 0.6%	0 0%
Within	152 92.7%	149 89.8%	155 93.9%	150 90.9%	48 88.9%
Above	9 5.5%	14 8.4%	7 4.2%	13 7.9%	3 5.6%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	1 0.6%	2 1.2%	0 0%	1 0.6%	0 0%
Within	152 92.7%	150 90.4%	154 93.3%	150 90.9%	46 85.2%
Above	7 4.3%	12 7.2%	6 3.6%	13 7.9%	5 9.3%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	1 0.6%	1 0.6%	3 1.8%	0 0%
Within	156 95.1%	154 92.8%	156 94.5%	148 89.7%	51 94.4%
Above	8 4.9%	11 6.6%	7 4.2%	14 8.5%	3 5.6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	1 0.6%	0 0%	0 0%	0 0%
Within	150 91.5%	151 91%	151 91.5%	151 91.5%	51 94.4%
Above	12 7.3%	12 7.2%	11 6.7%	13 7.9%	0 0%
Unknown	0 0%	0 0%	2 1.2%	0 0%	0 0%
Below	0 0%	3 1.8%	0 0%	0 0%	0 0%
Within	151 92.1%	146 88%	153 92.7%	153 92.7%	48 88.9%
Above	9 5.5%	15 9%	6 3.6%	11 6.7%	3 5.6%
Unknown	7 4.3%	11 6.6%	5 3%	6 3.6%	1 1.9%
Below	0 0%	1 0.6%	0 0%	0 0%	1 1.9%
Within	148 90.2%	147 88.6%	153 92.7%	153 92.7%	50 92.6%
Above	9 5.5%	7 4.2%	6 3.6%	6 3.6%	2 3.7%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	0 0%	1 0.6%	1 0.6%	1 0.6%	1 1.9%
Within	153 93.3%	155 93.4%	152 92.1%	154 93.3%	47 87%
Above	9 5.5%	8 4.8%	8 4.8%	9 5.5%	3 5.6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	2 1.2%	0 0%	1 1.9%
Within	150 91.5%	151 91%	147 89.1%	155 93.9%	48 88.9%
Above	10 6.1%	13 7.8%	12 7.3%	9 5.5%	2 3.7%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	3 1.8%	1 0.6%	2 1.2%	3 1.8%	0 0%
Within	70 42.7%	76 45.8%	72 43.6%	71 43%	23 42.6%
Above	1 0.6%	0 0%	1 0.6%	1 0.6%	1 1.9%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	4 2.4%	1 0.6%	5 3%	3 1.8%	0 0%
Within	68 41.5%	75 45.2%	68 41.2%	71 43%	22 40.7%
Above	0 0%	1 0.6%	1 0.6%	1 0.6%	0 0%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	5 3%	1 0.6%	2 1.2%	5 3%	0 0%
Within	64 39%	76 45.8%	70 42.4%	69 41.8%	21 38.9%
Above	1 0.6%	0 0%	0 0%	1 0.6%	0 0%
Unknown	8 4.9%	11 6.6%	5 3%	6 3.6%	1 1.9%
Below	13 7.9%	11 6.6%	12 7.3%	10 6.1%	2 3.7%
Within	130 79.3%	127 76.5%	135 81.8%	137 83%	47 87%
Above	13 7.9%	17 10.2%	12 7.3%	12 7.3%	4 7.4%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	11 6.7%	8 4.8%	15 9.1%	10 6.1%	3 5.6%
Within	140 85.4%	138 83.1%	128 77.6%	142 86.1%	43 79.6%
Above	11 6.7%	18 10.8%	18 10.9%	12 7.3%	5 9.3%
Unknown	1 0.6%	0 0%	0 0%	0 0%	0 0%
Below	10 6.1%	9 5.4%	12 7.3%	8 4.8%	2 3.7%
Within	127 77.4%	144 86.7%	126 76.4%	134 81.2%	45 83.3%
Above	22 13.4%	11 6.6%	23 13.9%	22 13.3%	4 7.4%
Unknown	1 0.6%	4 2.4%	4 2.4%	1 0.6%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	36 22%	34 20.5%	36 21.8%	39 23.6%	10 18.5%
Above	37 22.6%	39 23.5%	35 21.2%	35 21.2%	14 25.9%
Unknown	0 0%	1 0.6%	2 1.2%	1 0.6%	0 0%
Below	0 0%	0 0%	0 0%	1 0.6%	0 0%
Within	40 24.4%	35 21.1%	37 22.4%	35 21.2%	12 22.2%
Above	32 19.5%	41 24.7%	35 21.2%	38 23%	10 18.5%
Unknown	0 0%	1 0.6%	1 0.6%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	1 0.6%	0 0%
Within	40 24.4%	36 21.7%	40 24.2%	39 23.6%	9 16.7%
Above	30 18.3%	40 24.1%	32 19.4%	35 21.2%	12 22.2%
Unknown	1 0.6%	4 2.4%	0 0%	0 0%	0 0%
Below	21 12.8%	16 9.6%	27 16.4%	20 12.1%	4 7.4%
Within	141 86%	143 86.1%	129 78.2%	137 83%	50 92.6%
Above	1 0.6%	3 1.8%	8 4.8%	8 4.8%	0 0%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	27 16.5%	19 11.4%	25 15.2%	28 17%	4 7.4%
Within	133 81.1%	144 86.7%	131 79.4%	132 80%	46 85.2%
Above	2 1.2%	1 0.6%	5 3%	4 2.4%	1 1.9%
Unknown	0 0%	0 0%	0 0%	1 0.6%	0 0%
Below	30 18.3%	23 13.9%	25 15.2%	25 15.2%	6 11.1%
Within	128 78%	137 82.5%	134 81.2%	132 80%	45 83.3%
Above	2 1.2%	4 2.4%	2 1.2%	6 3.6%	0 0%
Unknown	1 0.6%	4 2.4%	0 0%	0 0%	0 0%
Below	23 14%	14 8.4%	19 11.5%	22 13.3%	8 14.8%
Within	138 84.1%	142 85.5%	142 86.1%	137 83%	46 85.2%
Above	2 1.2%	6 3.6%	3 1.8%	6 3.6%	0 0%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	26 15.9%	22 13.3%	26 15.8%	26 15.8%	6 11.1%
Within	134 81.7%	140 84.3%	134 81.2%	134 81.2%	45 83.3%
Above	2 1.2%	2 1.2%	1 0.6%	4 2.4%	0 0%
Unknown	0 0%	0 0%	0 0%	1 0.6%	0 0%
Below	27 16.5%	21 12.7%	26 15.8%	24 14.5%	7 13%
Within	131 79.9%	141 84.9%	133 80.6%	136 82.4%	44 81.5%
Above	2 1.2%	2 1.2%	2 1.2%	3 1.8%	0 0%
Unknown	1 0.6%	4 2.4%	0 0%	0 0%	0 0%
Below	3 1.8%	5 3%	2 1.2%	6 3.6%	1 1.9%
Within	153 93.3%	147 88.6%	153 92.7%	153 92.7%	52 96.3%
Above	7 4.3%	10 6%	9 5.5%	6 3.6%	1 1.9%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	3 1.8%	7 4.2%	3 1.8%	6 3.6%	0 0%
Within	152 92.7%	148 89.2%	153 92.7%	147 89.1%	46 85.2%
Above	7 4.3%	9 5.4%	5 3%	11 6.7%	5 9.3%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	2 1.2%	8 4.8%	5 3%	6 3.6%	0 0%
Within	150 91.5%	150 90.4%	149 90.3%	150 90.9%	50 92.6%
Above	8 4.9%	6 3.6%	7 4.2%	8 4.8%	1 1.9%
Unknown	7 4.3%	11 6.6%	5 3%	6 3.6%	1 1.9%
Below	18 11%	13 7.8%	24 14.5%	17 10.3%	5 9.3%
Within	137 83.5%	140 84.3%	130 78.8%	137 83%	44 81.5%
Above	2 1.2%	2 1.2%	5 3%	5 3%	4 7.4%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	15 9.1%	18 10.8%	23 13.9%	15 9.1%	7 13%
Within	144 87.8%	144 86.7%	131 79.4%	147 89.1%	42 77.8%
Above	3 1.8%	2 1.2%	7 4.2%	2 1.2%	2 3.7%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	12 7.3%	8 4.8%	19 11.5%	20 12.1%	7 13%
Within	144 87.8%	154 92.8%	138 83.6%	142 86.1%	42 77.8%
Above	4 2.4%	2 1.2%	4 2.4%	2 1.2%	2 3.7%
Unknown	1 0.6%	1 0.6%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	68 41.5%	68 41%	66 40%	70 42.4%	24 44.4%
Above	5 3%	8 4.8%	9 5.5%	5 3%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	64 39%	65 39.2%	64 38.8%	70 42.4%	21 38.9%
Above	8 4.9%	12 7.2%	10 6.1%	5 3%	1 1.9%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	63 38.4%	63 38%	66 40%	68 41.2%	20 37%
Above	7 4.3%	14 8.4%	6 3.6%	7 4.2%	1 1.9%
Unknown	7 4.3%	11 6.6%	5 3%	6 3.6%	1 1.9%
Below	1 0.6%	4 2.4%	1 0.6%	0 0%	1 1.9%
Within	148 90.2%	142 85.5%	147 89.1%	148 89.7%	49 90.7%
Above	8 4.9%	9 5.4%	11 6.7%	11 6.7%	3 5.6%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	0 0%	0 0%	2 1.2%	0 0%	0 0%
Within	153 93.3%	155 93.4%	146 88.5%	145 87.9%	48 88.9%
Above	9 5.5%	9 5.4%	13 7.9%	19 11.5%	3 5.6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	2 1.2%	1 0.6%	1 0.6%	3 1.8%	0 0%
Within	145 88.4%	151 91%	145 87.9%	148 89.7%	49 90.7%
Above	13 7.9%	12 7.2%	15 9.1%	13 7.9%	2 3.7%
Unknown	8 4.9%	11 6.6%	5 3%	6 3.6%	1 1.9%
Below	3 1.8%	2 1.2%	3 1.8%	3 1.8%	3 5.6%
Within	145 88.4%	141 84.9%	147 89.1%	146 88.5%	48 88.9%
Above	8 4.9%	12 7.2%	9 5.5%	10 6.1%	2 3.7%
Unknown	1 0.6%	0 0%	1 0.6%	0 0%	0 0%
Below	2 1.2%	5 3%	4 2.4%	6 3.6%	1 1.9%
Within	150 91.5%	152 91.6%	144 87.3%	151 91.5%	47 87%
Above	9 5.5%	7 4.2%	13 7.9%	7 4.2%	3 5.6%
Unknown	1 0.6%	0 0%	0 0%	0 0%	0 0%
Below	7 4.3%	3 1.8%	7 4.2%	6 3.6%	2 3.7%
Within	146 89%	157 94.6%	145 87.9%	149 90.3%	46 85.2%
Above	6 3.7%	4 2.4%	9 5.5%	9 5.5%	3 5.6%
Unknown	3 1.8%	4 2.4%	3 1.8%	0 0%	0 0%
Below	5 3%	2 1.2%	2 1.2%	3 1.8%	0 0%
Within	42 25.6%	42 25.3%	42 25.5%	43 26.1%	11 20.4%
Above	3 1.8%	7 4.2%	6 3.6%	5 3%	5 9.3%
Unknown	0 0%	1 0.6%	3 1.8%	1 0.6%	0 0%
Below	7 4.3%	4 2.4%	6 3.6%	3 1.8%	0 0%
Within	59 36%	58 34.9%	57 34.5%	64 38.8%	20 37%
Above	6 3.7%	11 6.6%	6 3.6%	6 3.6%	2 3.7%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	4 2.4%	4 2.4%	6 3.6%	5 3%	1 1.9%
Within	62 37.8%	61 36.7%	59 35.8%	62 37.6%	18 33.3%
Above	4 2.4%	12 7.2%	7 4.2%	8 4.8%	2 3.7%
Unknown	1 0.6%	4 2.4%	0 0%	0 0%	0 0%
Below	6 3.7%	4 2.4%	9 5.5%	10 6.1%	2 3.7%
Within	147 89.6%	150 90.4%	149 90.3%	148 89.7%	49 90.7%
Above	10 6.1%	8 4.8%	6 3.6%	7 4.2%	3 5.6%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	6 3.7%	7 4.2%	11 6.7%	12 7.3%	1 1.9%
Within	150 91.5%	152 91.6%	145 87.9%	145 87.9%	49 90.7%
Above	6 3.7%	5 3%	5 3%	7 4.2%	1 1.9%
Unknown	0 0%	0 0%	0 0%	1 0.6%	0 0%
Below	6 3.7%	6 3.6%	9 5.5%	12 7.3%	3 5.6%
Within	149 90.9%	153 92.2%	147 89.1%	148 89.7%	46 85.2%
Above	5 3%	5 3%	5 3%	3 1.8%	2 3.7%
Unknown	3 1.8%	3 1.8%	3 1.8%	0 0%	0 0%
Below	4 2.4%	9 5.4%	5 3%	5 3%	5 9.3%
Within	44 26.8%	38 22.9%	42 25.5%	44 26.7%	11 20.4%
Above	2 1.2%	5 3%	3 1.8%	2 1.2%	0 0%
Unknown	0 0%	1 0.6%	3 1.8%	1 0.6%	0 0%
Below	5 3%	10 6%	6 3.6%	7 4.2%	3 5.6%
Within	65 39.6%	62 37.3%	61 37%	65 39.4%	19 35.2%
Above	2 1.2%	1 0.6%	2 1.2%	1 0.6%	0 0%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	5 3%	10 6%	6 3.6%	8 4.8%	2 3.7%
Within	62 37.8%	64 38.6%	63 38.2%	64 38.8%	19 35.2%
Above	3 1.8%	3 1.8%	3 1.8%	3 1.8%	0 0%
Unknown	1 0.6%	5 3%	2 1.2%	1 0.6%	0 0%
Below	23 14%	21 12.7%	25 15.2%	23 13.9%	9 16.7%
Within	137 83.5%	135 81.3%	128 77.6%	136 82.4%	42 77.8%
Above	3 1.8%	5 3%	9 5.5%	5 3%	3 5.6%
Unknown	0 0%	1 0.6%	1 0.6%	0 0%	0 0%
Below	25 15.2%	23 13.9%	27 16.4%	24 14.5%	8 14.8%
Within	136 82.9%	138 83.1%	128 77.6%	135 81.8%	42 77.8%
Above	1 0.6%	2 1.2%	6 3.6%	5 3%	1 1.9%
Unknown	1 0.6%	0 0%	0 0%	1 0.6%	0 0%
Below	27 16.5%	23 13.9%	26 15.8%	23 13.9%	5 9.3%
Within	129 78.7%	138 83.1%	131 79.4%	136 82.4%	46 85.2%
Above	3 1.8%	3 1.8%	4 2.4%	4 2.4%	0 0%
Unknown	1 0.6%	1 0.6%	1 0.6%	0 0%	0 0%
Below	4 2.4%	2 1.2%	3 1.8%	3 1.8%	0 0%
Within	130 79.3%	132 79.5%	128 77.6%	135 81.8%	43 79.6%
Above	29 17.7%	31 18.7%	32 19.4%	27 16.4%	11 20.4%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	3 1.8%	2 1.2%	1 0.6%	3 1.8%	2 3.7%
Within	135 82.3%	131 78.9%	129 78.2%	131 79.4%	38 70.4%
Above	24 14.6%	31 18.7%	32 19.4%	30 18.2%	11 20.4%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	3 1.8%	3 1.8%	2 1.2%	2 1.2%	0 0%
Within	132 80.5%	127 76.5%	130 78.8%	134 81.2%	42 77.8%
Above	25 15.2%	34 20.5%	28 17%	28 17%	9 16.7%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	6 3.7%	2 1.2%	9 5.5%	3 1.8%	1 1.9%
Within	68 41.5%	75 45.2%	66 40%	72 43.6%	23 42.6%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Below	6 3.7%	2 1.2%	9 5.5%	4 2.4%	2 3.7%
Within	66 40.2%	75 45.2%	65 39.4%	71 43%	20 37%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown	0 0%	0 0%	1 0.6%	0 0%	0 0%
Below	3 1.8%	7 4.2%	13 7.9%	6 3.6%	0 0%
Within	67 40.9%	70 42.2%	58 35.2%	69 41.8%	21 38.9%
Above	0 0%	0 0%	1 0.6%	0 0%	0 0%

25. Secondary Outcome

Title	Number of German Subjects With Different Biochemical and Haematological Levels
Description	Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.
Time Frame	At one week post-vaccination 1 (Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	22	24	24	24	8
Below	8 4.9%	7 4.2%	10 6.1%	7 4.2%	2 3.7%
Within	0 0%	0 0%	0 0%	0 0%	0 0%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%
Below	3 1.8%	5 3%	2 1.2%	4 2.4%	2 3.7%
Within	12 7.3%	12 7.2%	12 7.3%	12 7.3%	4 7.4%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	1 0.6%	0 0%	0 0%	1 0.6%	0 0%
Below	1 0.6%	1 0.6%
Within	1 0.6%	0 0%
Above	0 0%	0 0%
Missing	0 0%	0 0%
Below	1 0.6%	0 0%	1 0.6%	0 0%	0 0%
Within	19 11.6%	23 13.9%	21 12.7%	22 13.3%	8 14.8%
Above	0 0%	0 0%	2 1.2%	1 0.6%	0 0%
Missing	1 0.6%	0 0%	0 0%	1 0.6%	0 0%
Below	0 0%
Within	1 0.6%
Above	0 0%
Missing	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	9 5.5%	5 3%	8 4.8%	13 7.9%	4 7.4%
Above	6 3.7%	8 4.8%	4 2.4%	3 1.8%	1 1.9%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	0 0%	0 0%	2 1.2%	3 1.8%	0 0%
Above	8 4.9%	11 6.6%	10 6.1%	4 2.4%	3 5.6%
Missing	1 0.6%	0 0%	0 0%	1 0.6%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	18 11%	19 11.4%	19 11.5%	22 13.3%	8 14.8%
Above	2 1.2%	0 0%	1 0.6%	0 0%	0 0%
Missing	1 0.6%	0 0%	0 0%	1 0.6%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	1 0.6%	3 1.8%	1 0.6%	1 0.6%
Above	1 0.6%	2 1.2%	3 1.8%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%
Below	0 0%
Within	0 0%
Above	1 0.6%
Missing	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	0 0%	0 0%	0 0%	0 0%	0 0%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	22 13.4%	24 14.5%	23 13.9%	24 14.5%	8 14.8%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	0 0%	0 0%	0 0%	0 0%	0 0%
Above	0 0%	0 0%	1 0.6%	0 0%	0 0%
Missing	22 13.4%	24 14.5%	22 13.3%	24 14.5%	8 14.8%
Below	0 0%	0 0%
Within	2 1.2%	1 0.6%
Above	0 0%	0 0%
Missing	0 0%	0 0%
Below	0 0%	0 0%	2 1.2%	1 0.6%	0 0%
Within	21 12.8%	24 14.5%	21 12.7%	22 13.3%	8 14.8%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	1 0.6%	0 0%	0 0%	1 0.6%	0 0%

26. Secondary Outcome

Title	Number of German Subjects With Different Biochemical and Haematological Levels
Description	Among biochemical and haematological parameters assessed were albumin [ALB], calcium [CAL], fibrinogen [FIB], lactate dehydrogenase [LDH], partial thrombo-plastin time [PTPT], pro thrombin time [PTT], total protein [TP]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - below, within, above and missing, as compared to the pre-vaccination status (below, within, above or missing). Values for electrophoresis (globulins and albumin/globulin ratio) were not displayed.
Time Frame	At one week post-vaccination 2 (Month 2)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	22	24	24	24	8
Below	4 2.4%	6 3.6%	8 4.8%	6 3.6%	2 3.7%
Within	1 0.6%	1 0.6%	1 0.6%	0 0%	0 0%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	3 1.8%	0 0%	1 0.6%	1 0.6%	0 0%
Below	2 1.2%	2 1.2%	2 1.2%	4 2.4%	1 1.9%
Within	12 7.3%	15 9%	11 6.7%	12 7.3%	5 9.3%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	2 1.2%	0 0%	1 0.6%	1 0.6%	0 0%
Below	1 0.6%	0 0%
Within	0 0%	1 0.6%
Above	0 0%	0 0%
Missing	1 0.6%	0 0%
Below	0 0%	0 0%	2 1.2%	0 0%	0 0%
Within	16 9.8%	23 13.9%	20 12.1%	22 13.3%	8 14.8%
Above	1 0.6%	0 0%	0 0%	0 0%	0 0%
Missing	4 2.4%	0 0%	2 1.2%	2 1.2%	0 0%
Below	0 0%
Within	1 0.6%
Above	0 0%
Missing	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	8 4.9%	8 4.8%	6 3.6%	11 6.7%	4 7.4%
Above	5 3%	5 3%	5 3%	3 1.8%	1 1.9%
Missing	2 1.2%	0 0%	1 0.6%	2 1.2%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	0 0%	1 0.6%	3 1.8%	1 0.6%	0 0%
Above	6 3.7%	10 6%	8 4.8%	7 4.2%	3 5.6%
Missing	3 1.8%	0 0%	1 0.6%	0 0%	0 0%
Below	0 0%	0 0%	0 0%	0 0%	0 0%
Within	14 8.5%	16 9.6%	15 9.1%	20 12.1%	8 14.8%
Above	2 1.2%	3 1.8%	3 1.8%	1 0.6%	0 0%
Missing	5 3%	0 0%	2 1.2%	2 1.2%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	0 0%	4 2.4%	1 0.6%	1 0.6%
Above	2 1.2%	1 0.6%	3 1.8%	0 0%
Missing	0 0%	0 0%	0 0%	0 0%
Below	0 0%
Within	1 0.6%
Above	0 0%
Missing	0 0%
Below	0 0%	1 0.6%	2 1.2%	1 0.6%	0 0%
Within	18 11%	22 13.3%	20 12.1%	19 11.5%	8 14.8%
Above	1 0.6%	1 0.6%	0 0%	2 1.2%	0 0%
Missing	3 1.8%	0 0%	1 0.6%	2 1.2%	0 0%
Below	1 0.6%	1 0.6%	0 0%	2 1.2%	0 0%
Within	18 11%	23 13.9%	22 13.3%	20 12.1%	8 14.8%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	3 1.8%	0 0%	1 0.6%	2 1.2%	0 0%
Below	0 0%	0 0%
Within	0 0%	1 0.6%
Above	0 0%	0 0%
Missing	2 1.2%	0 0%
Below	0 0%	0 0%	2 1.2%	2 1.2%	0 0%
Within	19 11.6%	24 14.5%	19 11.5%	20 12.1%	8 14.8%
Above	0 0%	0 0%	0 0%	0 0%	0 0%
Missing	3 1.8%	0 0%	2 1.2%	2 1.2%	0 0%

27. Secondary 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 activity. 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 a least one vaccine administration documented, who filled in their symptom sheets.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	164	166	165	165	54
Any Pain, Dose 1	94 57.3%	11 6.6%	99 60%	2 1.2%	7 13%
Grade 3 Pain, Dose 1	0 0%	0 0%	3 1.8%	0 0%	0 0%
Any Redness, Dose 1	40 24.4%	49 29.5%	43 26.1%	1 0.6%	2 3.7%
Grade 3 Redness, Dose 1	2 1.2%	2 1.2%	3 1.8%	0 0%	0 0%
Any Swelling, Dose 1	26 15.9%	21 12.7%	24 14.5%	3 1.8%	1 1.9%
Grade 3 Swelling, Dose 1	1 0.6%	2 1.2%	2 1.2%	0 0%	0 0%
Any Pain, Dose 2	99 60.4%	93 56%	99 60%	93 56.4%	4 7.4%
Grade 3 Pain, Dose 2	4 2.4%	3 1.8%	3 1.8%	3 1.8%	0 0%
Any Redness, Dose 2	51 31.1%	54 32.5%	52 31.5%	48 29.1%	2 3.7%
Grade 3 Redness, Dose 2	1 0.6%	3 1.8%	2 1.2%	2 1.2%	0 0%
Any Swelling, Dose 2	30 18.3%	23 13.9%	30 18.2%	27 16.4%	0 0%
Grade 3 Swelling, Dose 2	0 0%	0 0%	1 0.6%	0 0%	0 0%
Any Pain, Across doses	115 70.1%	12 7.2%	122 73.9%	93 56.4%	9 16.7%
Grade 3 Pain, Across doses	4 2.4%	3 1.8%	6 3.6%	3 1.8%	0 0%
Any Redness, Across doses	68 41.5%	66 39.8%	68 41.2%	49 29.7%	2 3.7%
Grade 3 Redness, Across doses	2 1.2%	5 3%	4 2.4%	2 1.2%	0 0%
Any Swelling, Across doses	44 26.8%	33 19.9%	45 27.3%	30 18.2%	1 1.9%
Grade 3 Swelling, Across doses	1 0.6%	2 1.2%	2 1.2%	0 0%	0 0%

28. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. 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 a least one vaccine administration documented, who filled in their symptom sheets.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	164	166	165	165	54
Any Fatigue, Dose 1	36 22%	48 28.9%	46 27.9%	20 12.1%	8 14.8%
Grade 3 Fatigue, Dose 1	1 0.6%	2 1.2%	2 1.2%	2 1.2%	1 1.9%
Related Fatigue, Dose 1	30 18.3%	34 20.5%	34 20.6%	12 7.3%	6 11.1%
Any Fever, Dose 1	7 4.3%	7 4.2%	5 3%	4 2.4%	0 0%
Grade 3 Fever, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%
Related Fever, Dose 1	7 4.3%	5 3%	3 1.8%	4 2.4%	0 0%
Any Headache, Dose 1	23 14%	25 15.1%	24 14.5%	13 7.9%	7 13%
Grade 3 Headache, Dose 1	0 0%	0 0%	2 1.2%	0 0%	0 0%
Related Headache, Dose 1	19 11.6%	17 10.2%	13 7.9%	6 3.6%	6 11.1%
Any Myalgia, Dose 1	48 29.3%	57 34.3%	46 27.9%	11 6.7%	8 14.8%
Grade 3 Myalgia, Dose 1	1 0.6%	2 1.2%	2 1.2%	1 0.6%	0 0%
Related Myalgia, Dose 1	41 25%	52 31.3%	41 24.8%	10 6.1%	6 11.1%
Any Fatigue, Dose 2	56 34.1%	70 42.2%	52 31.5%	38 23%	9 16.7%
Grade 3 Fatigue, Dose 2	2 1.2%	6 3.6%	4 2.4%	1 0.6%	0 0%
Related Fatigue, Dose 2	47 28.7%	48 28.9%	43 26.1%	27 16.4%	7 13%
Any Fever, Dose 2	13 7.9%	13 7.8%	18 10.9%	5 3%	0 0%
Grade 3 Fever, Dose 2	0 0%	1 0.6%	0 0%	0 0%	0 0%
Related Fever, Dose 2	12 7.3%	12 7.2%	18 10.9%	5 3%	0 0%
Any Headache, Dose 2	39 23.8%	47 28.3%	39 23.6%	27 16.4%	7 13%
Grade 3 Headache, Dose 2	2 1.2%	3 1.8%	2 1.2%	0 0%	0 0%
Related Headache, Dose 2	32 19.5%	32 19.3%	35 21.2%	21 12.7%	5 9.3%
Any Myalgia, Dose 2	59 36%	71 42.8%	59 35.8%	46 27.9%	5 9.3%
Grade 3 Myalgia, Dose 2	4 2.4%	7 4.2%	4 2.4%	2 1.2%	0 0%
Related Myalgia, Dose 2	52 31.7%	61 36.7%	57 34.5%	41 24.8%	4 7.4%
Any Fatigue, Across doses	69 42.1%	85 51.2%	73 44.2%	47 28.5%	1 1.9%
Grade 3 Fatigue, Across doses	3 1.8%	7 4.2%	6 3.6%	3 1.8%	1 1.9%
Related Fatigue, Across doses	57 34.8%	60 36.1%	59 35.8%	33 20%	9 16.7%
Any Fever, Across doses	19 11.6%	18 10.8%	22 13.3%	9 5.5%	0 0%
Grade 3 Fever, Across doses	0 0%	1 0.6%	0 0%	0 0%	0 0%
Related Fever, Across doses	18 11%	15 9%	20 12.1%	9 5.5%	0 0%
Any Headache, Across doses	47 28.7%	59 35.5%	51 30.9%	36 21.8%	9 16.7%
Grade 3 Headache, Across doses	2 1.2%	3 1.8%	4 2.4%	0 0%	0 0%
Related Headache, Across doses	39 23.8%	41 24.7%	42 25.5%	25 15.2%	7 13%
Any Myalgia, Across doses	74 45.1%	89 53.6%	70 42.4%	49 29.7%	9 16.7%
Grade 3 Myalgia, Across doses	5 3%	8 4.8%	6 3.6%	3 1.8%	0 0%
Related Myalgia, Across doses	66 40.2%	80 48.2%	67 40.6%	46 27.9%	7 13%

29. Secondary Outcome

Title	Number of Subjects With Occurrence of Clinically Diagnosed Herpes Zoster (HZ) Episodes
Description	Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.
Time Frame	From Month 0 to Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	164	166	165	165	54
Count of Participants [Participants]	1 0.6%	0 0%	0 0%	0 0%	0 0%

30. Secondary Outcome

Title	Number of Subjects With Occurrence of Clinically Diagnosed HZ Episodes
Description	Clinically diagnosed episodes included rash that was assessed by hives, idiopathic thrombocytopenic purpura, petechiae.
Time Frame	From Month 3 up to Month 36

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	156	159	159	161	50
Month 3 - Month 12	0 0%	0 0%	0 0%	1 0.6%	0 0%
Month 12 - Month 24	1 0.6%	0 0%	0 0%	0 0%	0 0%
Month 24 - Month 36	0 0%	0 0%	0 0%	0 0%	1 1.9%

31. Secondary 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 a least one vaccine administration documented.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	164	166	165	165	54
Any AE(s)	55 33.5%	52 31.3%	54 32.7%	41 24.8%	16 29.6%
Grade 3 AE(s)	7 4.3%	10 6%	10 6.1%	5 3%	4 7.4%
Related AE(s)	20 12.2%	22 13.3%	24 14.5%	13 7.9%	2 3.7%

32. Secondary 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.
Time Frame	From Month 0 to Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with a least one vaccine administration documented.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	164	166	165	165	54
Count of Participants [Participants]	2 1.2%	4 2.4%	3 1.8%	6 3.6%	3 5.6%

33. Secondary 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.
Time Frame	From Month 3 to Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total cohort for persistence at Months 12, 24 and 36, which included all vaccinated subjects in the vaccination phase (Zoster-003) who were contacted at Months 12, 24 and 36.

Arm/Group Title	GSK1437173A _LD Group	GSK1437173A _MD Group	GSK1437173A _HD Group	Placebo + GSK1437173A _HD Group	GSK1437173A_MODIFIED Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.	Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
Measure Participants	156	159	159	161	50
Month 3 - Month 12	11 6.7%	14 8.4%	11 6.7%	16 9.7%	3 5.6%
Month 12 - Month 24	21 12.8%	27 16.3%	29 17.6%	25 15.2%	11 20.4%
Month 24 - Month 36	19 11.6%	12 7.2%	25 15.2%	20 12.1%	5 9.3%

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: during the entire study period (from Day 0 to Month 36).
Arm/Group Title	GSK1437173A _LD Group		GSK1437173A _MD Group		GSK1437173A _HD Group		Placebo + GSK1437173A _HD Group		Placebo Group
Arm/Group Description	Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) low dose (LD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by intramuscular injection (IM) in the upper deltoid site of the left arm.		Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) medium dose (MD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.		Healthy male or female subjects aged 60 years or older, who received 2 doses of herpes zoster subunit vaccine (GSK1437173A) high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.		Healthy male or female subjects aged 60 years or older, who received a 1st dose of saline solution and a 2nd dose of GSK1437173A high dose (HD) formulation, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.		Healthy male or female subjects aged 60 years or older, who received 2 doses of GSK1437173A modified formulation vaccine reconstituted with saline solution, according to a 0, 2-month schedule. The vaccine was administrated by (IM) in the upper deltoid site of the left arm.
All Cause Mortality
	GSK1437173A _LD Group		GSK1437173A _MD Group		GSK1437173A _HD Group		Placebo + GSK1437173A _HD Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/164 (1.2%)		3/166 (1.8%)		3/165 (1.8%)		5/165 (3%)		1/54 (1.9%)
Serious Adverse Events
	GSK1437173A _LD Group		GSK1437173A _MD Group		GSK1437173A _HD Group		Placebo + GSK1437173A _HD Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/164 (32.3%)		57/166 (34.3%)		68/165 (41.2%)		67/165 (40.6%)		22/54 (40.7%)
Blood and lymphatic system disorders
Anaemia	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	2	0/54 (0%)	0
Iron deficiency anaemia	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Microcytic anaemia	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Cardiac disorders
Acute myocardial infarction	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	1/54 (1.9%)	1
Angina pectoris	0/164 (0%)	0	2/166 (1.2%)	2	4/165 (2.4%)	4	3/165 (1.8%)	3	0/54 (0%)	0
Angina unstable	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Arrhythmia supraventricular	1/164 (0.6%)	2	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Atrial fibrillation	0/164 (0%)	0	2/166 (1.2%)	2	0/165 (0%)	0	3/165 (1.8%)	3	1/54 (1.9%)	1
Atrial flutter	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Atrioventricular block	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Atrioventricular block first degree	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Bradyarrhythmia	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	3/54 (5.6%)	4
Cardiac failure	3/164 (1.8%)	3	2/166 (1.2%)	2	1/165 (0.6%)	1	1/165 (0.6%)	1	2/54 (3.7%)	2
Cardiac failure congestive	0/164 (0%)	0	2/166 (1.2%)	2	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Cardiomyopathy	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Coronary artery disease	3/164 (1.8%)	3	2/166 (1.2%)	2	2/165 (1.2%)	2	0/165 (0%)	0	0/54 (0%)	0
Coronary artery stenosis	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Myocardial infarction	1/164 (0.6%)	1	1/166 (0.6%)	1	1/165 (0.6%)	1	2/165 (1.2%)	2	0/54 (0%)	0
Myocardial ischaemia	1/164 (0.6%)	1	1/166 (0.6%)	1	2/165 (1.2%)	2	1/165 (0.6%)	1	0/54 (0%)	0
Right ventricular failure	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Sick sinus syndrome	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Sinoatrial block	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Tachyarrhythmia	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Ear and labyrinth disorders
Meniere's disease	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Vertigo	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Vestibular disorder	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Endocrine disorders
Hyperthyroidism	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Eye disorders
Cataract	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Retinal detachment	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Retinal vein thrombosis	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Gastrointestinal disorders
Colitis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Colitis ulcerative	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Crohn's disease	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Diabetic gastropathy	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Duodenal ulcer	0/164 (0%)	0	2/166 (1.2%)	2	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Enteritis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Gastric ulcer	1/164 (0.6%)	1	2/166 (1.2%)	2	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Gastritis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Gastrointestinal haemorrhage	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Haemorrhoidal haemorrhage	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Ileus paralytic	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Inguinal hernia	0/164 (0%)	0	3/166 (1.8%)	3	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Intestinal polyp	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Pancreatitis	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Pancreatitis acute	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Peptic ulcer perforation	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Rectal prolapse	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Subileus	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Tooth disorder	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Upper gastrointestinal haemorrhage	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
General disorders
Chest pain	2/164 (1.2%)	2	1/166 (0.6%)	1	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Cyst	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Device dislocation	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Drowning	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Gait disturbance	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Medical device complication	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Hepatobiliary disorders
Bile duct stenosis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Bile duct stone	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Cholecystitis	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	2/165 (1.2%)	2	0/54 (0%)	0
Cholelithiasis	1/164 (0.6%)	1	1/166 (0.6%)	1	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Immune system disorders
Allergy to arthropod bite	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Amyloidosis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Infections and infestations
Appendicitis	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Clostridial infection	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Cystitis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Diabetic gangrene	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Diverticulitis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	3/165 (1.8%)	3	1/54 (1.9%)	1
Erysipelas	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Febrile infection	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Gastroenteritis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Gastroenteritis aeromonas	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Gastroenteritis clostridial	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Helicobacter gastritis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Lymphangitis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Neuroborreliosis	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Pancreatic abscess	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Pneumonia	0/164 (0%)	0	2/166 (1.2%)	2	0/165 (0%)	0	1/165 (0.6%)	1	1/54 (1.9%)	1
Pneumonia primary atypical	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Pseudomembranous colitis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Sinusitis aspergillus	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Upper respiratory tract infection	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Urinary tract infection	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Urosepsis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Injury, poisoning and procedural complications
Ankle fracture	0/164 (0%)	0	1/166 (0.6%)	1	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Asbestosis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Cervical vertebral fracture	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Contusion	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Facial bones fracture	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Femoral neck fracture	0/164 (0%)	0	1/166 (0.6%)	1	2/165 (1.2%)	2	0/165 (0%)	0	0/54 (0%)	0
Femur fracture	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	1/54 (1.9%)	1
Hand fracture	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Humerus fracture	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Joint dislocation	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Ligament rupture	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Lumbar vertebral fracture	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Meniscus lesion	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Multiple fractures	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Post procedural haematoma	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Postoperative ileus	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Radius fracture	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	1/54 (1.9%)	1
Rib fracture	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Skull fracture	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Skull fractured base	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Spinal fracture	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Tendon rupture	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Tibia fracture	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	1/54 (1.9%)	1
Tooth injury	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Vascular pseudoaneurysm	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Wrist fracture	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Hyperglycaemia	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	2/54 (3.7%)	2
Arthropathy	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Back disorder	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Back pain	1/164 (0.6%)	1	2/166 (1.2%)	2	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Bone cyst	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Bone pain	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Groin pain	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Intervertebral disc protrusion	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Lumbar spinal stenosis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Muscle atrophy	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Osteoarthritis	2/164 (1.2%)	2	1/166 (0.6%)	1	5/165 (3%)	5	3/165 (1.8%)	3	1/54 (1.9%)	1
Osteoporotic fracture	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Rotator cuff syndrome	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Spinal column stenosis	1/164 (0.6%)	1	3/166 (1.8%)	3	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Synovial cyst	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Tenosynovitis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	2	0/165 (0%)	0	0/54 (0%)	0
Trigger finger	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Bladder cancer	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Breast cancer	2/164 (1.2%)	2	2/166 (1.2%)	2	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Bronchial carcinoma	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Chronic myeloid leukaemia	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Colon adenoma	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Colon cancer	0/164 (0%)	0	1/166 (0.6%)	1	2/165 (1.2%)	2	1/165 (0.6%)	1	0/54 (0%)	0
Colon neoplasm	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Haemangiopericytoma	2/164 (1.2%)	2	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Hypopharyngeal cancer stage iii	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Lung neoplasm malignant	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Malignant melanoma	0/164 (0%)	0	0/166 (0%)	0	2/165 (1.2%)	2	0/165 (0%)	0	0/54 (0%)	0
Melanoma recurrent	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Ovarian fibroma	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Ovarian neoplasm	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Pleural mesothelioma	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Prostate cancer	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Prostate cancer recurrent	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Rectal cancer	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Renal cancer	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Renal neoplasm	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Salivary gland neoplasm	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Squamous cell carcinoma	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Nervous system disorders
Carotid artery stenosis	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Carpal tunnel syndrome	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Cerebellar infarction	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Cerebral ischaemia	1/164 (0.6%)	1	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Cerebrovascular accident	2/164 (1.2%)	2	1/166 (0.6%)	1	3/165 (1.8%)	3	0/165 (0%)	0	0/54 (0%)	0
Cerebrovascular disorder	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Dementia	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Dizziness	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Drop attacks	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Epilepsy	0/164 (0%)	0	1/166 (0.6%)	1	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Haemorrhage intracranial	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Ischaemic stroke	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	1/54 (1.9%)	1
Neuropathy peripheral	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Partial seizures	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Somnolence	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Subarachnoid haemorrhage	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Syncope	1/164 (0.6%)	1	1/166 (0.6%)	2	0/165 (0%)	0	2/165 (1.2%)	2	0/54 (0%)	0
Transient ischaemic attack	3/164 (1.8%)	3	0/166 (0%)	0	1/165 (0.6%)	1	4/165 (2.4%)	4	0/54 (0%)	0
Vascular encephalopathy	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Viith nerve paralysis	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Psychiatric disorders
Depression	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	1/54 (1.9%)	1
Renal and urinary disorders
Glomerulonephritis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Haematuria	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	1/165 (0.6%)	1	0/54 (0%)	0
Oliguria	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Renal failure	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Renal failure acute	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Stress urinary incontinence	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Urethral stenosis	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/164 (0.6%)	1	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Breast pain	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Cystocele	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Prostatitis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Uterine polyp	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Uterine prolapse	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Chronic obstructive pulmonary disease	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Dyspnoea	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Skin and subcutaneous tissue disorders
Psoriasis	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Rash	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	1/165 (0.6%)	1	0/54 (0%)	0
Rosacea	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Vascular disorders
Aortic aneurysm	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Aortic stenosis	0/164 (0%)	0	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	1/54 (1.9%)	1
Arteriosclerosis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Circulatory collapse	1/164 (0.6%)	1	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Femoral arterial stenosis	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Haemorrhage	1/164 (0.6%)	1	0/166 (0%)	0	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Hypertension	0/164 (0%)	0	2/166 (1.2%)	2	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Hypertensive crisis	0/164 (0%)	0	0/166 (0%)	0	2/165 (1.2%)	2	2/165 (1.2%)	2	0/54 (0%)	0
Orthostatic hypotension	0/164 (0%)	0	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Peripheral arterial occlusive disease	1/164 (0.6%)	1	1/166 (0.6%)	1	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Varicose vein	0/164 (0%)	0	2/166 (1.2%)	2	0/165 (0%)	0	0/165 (0%)	0	0/54 (0%)	0
Venous thrombosis	0/164 (0%)	0	0/166 (0%)	0	1/165 (0.6%)	1	0/165 (0%)	0	0/54 (0%)	0
Other (Not Including Serious) Adverse Events
	GSK1437173A _LD Group		GSK1437173A _MD Group		GSK1437173A _HD Group		Placebo + GSK1437173A _HD Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	134/164 (81.7%)		142/166 (85.5%)		140/165 (84.8%)		124/165 (75.2%)		19/54 (35.2%)
General disorders
Fatigue	69/164 (42.1%)	92	85/166 (51.2%)	118	73/165 (44.2%)	99	47/165 (28.5%)	58	12/54 (22.2%)	17
Pain	115/164 (70.1%)	193	121/166 (72.9%)	205	122/165 (73.9%)	199	93/165 (56.4%)	95	9/54 (16.7%)	11
Pyrexia	20/164 (12.2%)	21	19/166 (11.4%)	21	22/165 (13.3%)	23	9/165 (5.5%)	9	0/54 (0%)	0
Swelling	43/164 (26.2%)	55	32/166 (19.3%)	43	45/165 (27.3%)	54	30/165 (18.2%)	30	1/54 (1.9%)	1
Musculoskeletal and connective tissue disorders
Myalgia	75/164 (45.7%)	109	89/166 (53.6%)	128	70/165 (42.4%)	105	49/165 (29.7%)	57	9/54 (16.7%)	13
Nervous system disorders
Headache	48/164 (29.3%)	65	60/166 (36.1%)	73	51/165 (30.9%)	64	36/165 (21.8%)	40	9/54 (16.7%)	14
Skin and subcutaneous tissue disorders
Erythema	68/164 (41.5%)	91	65/166 (39.2%)	102	68/165 (41.2%)	96	50/165 (30.3%)	50	2/54 (3.7%)	4

Limitations/Caveats

[Not Specified]

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Certain Agreements

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.