Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01165229
• Collaborator: (none)
• Enrollment: 14,819
• Locations: 213
• Arms: 2
• Actual Duration (Months): 59.7
• Patients Per Site: 69.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

Condition or Disease	Intervention/Treatment	Phase
Herpes Zoster; Herpes Zoster Vaccine	Biological: Herpes Zoster Vaccine GSK1437173A; Biological: Placebo	Phase 3

Detailed Description

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14819 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
• Actual Study Start Date: Aug 2, 2010
• Actual Primary Completion Date: Jul 24, 2015
• Actual Study Completion Date: Jul 24, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zoster vaccine group Subjects will receive Herpes Zoster Vaccine GSK1437173A according to a 0, 2-month schedule	Biological: Herpes Zoster Vaccine GSK1437173A; Intramuscular injection
Placebo Comparator: Placebo group Subjects will receive NaCl solution placebo according to a 0, 2-month schedule	Biological: Placebo; Intramuscular injection.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Any Episodes of Herpes Zoster (HZ) [During the entire study period (3 to 5 year period following Day 0)]

   Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).

2. Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) [During the entire study period (3 to 5 year period following Day 0)]

   Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).

3. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ [During the entire study period (3 to 5 year period following Day 0)]

   Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.

Secondary Outcome Measures

1. Number of Subjects With Post-herpetic Neuralgia (PHN) [During the entire study period (3 to 5 year period following Day 0)]

   PHN cases in the mTVc.

2. Number of Days With Severe 'Worst' HZ-associated Pain [During the entire study period (3 to 5 year period following Day 0)]

   Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.

3. Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations [During the entire study period (3 to 5 year period following Day 0)]

   The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.

4. Number of Subjects With Overall Mortality and HZ-related Mortality [During the entire study period (3 to 5 year period following Day 0)]

   The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.

5. Number of Subjects With Confirmed HZ Episode Related Hospitalizations [During the entire study period (3 to 5 year period following Day 0)]

   Incidence of overall and HZ-related hospitalizations during the study.

6. Number of Subjects With HZ Related Complications [During the entire study period (3 to 5 year period following Day 0)]

   Incidence of HZ complications during the study in subjects with confirmed HZ.

7. Number of Subjects Receiving Pain Medication Associated With HZ [During the entire study period (3 to 5 year period following Day 0)]

   Incidence of use of pain medications throughout the study

8. Number of Days With Pain Medication Associated With HZ [During the entire study period (3 to 5 year period following Day 0)]

   Incidence of reduction of duration of pain medication associated with HZ throughout the study.

9. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

   Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

10. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

11. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Within the 30 days (Days 0-29) after each vaccination]

    Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. 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.

12. Number of Subjects With Any and Related Serious Adverse Events (SAEs) [From Month 0 to Month 14]

    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.

13. Number of Subjects With Fatal Serious Adverse Events (SAEs) [During the entire study period (3 to 5 year period following Day 0)]

    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.

14. Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication [During the entire study period (3 to 5 year period following day 0)]

    The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated

15. Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) [During the entire study period (3 to 5 year period following Day 0)]

    Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects

16. Number of Subjects With Any and Related Medically Attended Visits [From Month 0 to Month 8 post-vaccination]

    Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.

17. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA [During the entire study period (3 to 5 year period following Day 0)]

    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

18. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ [During the entire study period (3 to 5 year period following Day 0)]

    Occurrence of PHN during the entire study period in all subjects with confirmed HZ.

19. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. [During the entire study period (3 to 5 year period following Day 0)]

    The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .

20. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ. [During the entire study period (3 to 5 year period following Day 0)]

    Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.

21. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. 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.

22. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

23. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA [Within 30 days (Days 0 - 29) after each vaccination]

    Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.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.

24. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs [From Month 0 to Month 14]

    Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.

25. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs [During the entire study period (3 to 5 year period following Day 0)]

    Fatal SAEs during the entire study period in subjects ≥ 70 YOA.

26. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs [During the entire study period (3 to 5 year period following Day 0)]

    Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.

27. Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits [From Month 0 to Month 8 post-vaccination]

    Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes will comply with the requirements of the protocol.

• Written informed consent obtained from the subject.

• A male or female aged 70 years or older at the time of the first vaccination.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.

• Previous vaccination against varicella or HZ.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.

• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.

• Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.

• Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.

• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

• Acute disease and/or fever at the time of enrolment.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Mesa	Arizona	United States	85213
2	GSK Investigational Site	Phoenix	Arizona	United States	85018
3	GSK Investigational Site	Phoenix	Arizona	United States	85020
4	GSK Investigational Site	Phoenix	Arizona	United States	85050
5	GSK Investigational Site	Tucson	Arizona	United States	85704
6	GSK Investigational Site	Spring Valley	California	United States	91978
7	GSK Investigational Site	Vista	California	United States	92083
8	GSK Investigational Site	Clearwater	Florida	United States	33761
9	GSK Investigational Site	DeLand	Florida	United States	32720
10	GSK Investigational Site	Jacksonville	Florida	United States	32205
11	GSK Investigational Site	Jacksonville	Florida	United States	32216
12	GSK Investigational Site	West Palm Beach	Florida	United States	33409
13	GSK Investigational Site	Meridian	Idaho	United States	83642
14	GSK Investigational Site	Overland Park	Kansas	United States	66212
15	GSK Investigational Site	Wichita	Kansas	United States	67207
16	GSK Investigational Site	Baltimore	Maryland	United States	21209
17	GSK Investigational Site	Columbia	Maryland	United States	21045
18	GSK Investigational Site	Kansas City	Missouri	United States	64114
19	GSK Investigational Site	Las Vegas	Nevada	United States	89104
20	GSK Investigational Site	Las Vegas	Nevada	United States	89119
21	GSK Investigational Site	Edison	New Jersey	United States	08817
22	GSK Investigational Site	Somers Point	New Jersey	United States	08244
23	GSK Investigational Site	Cary	North Carolina	United States	27518
24	GSK Investigational Site	Charlotte	North Carolina	United States	28209
25	GSK Investigational Site	Hickory	North Carolina	United States	28602
26	GSK Investigational Site	Salisbury	North Carolina	United States	28144
27	GSK Investigational Site	Wilmington	North Carolina	United States	28401
28	GSK Investigational Site	Winston-Salem	North Carolina	United States	27103
29	GSK Investigational Site	Cleveland	Ohio	United States	44122
30	GSK Investigational Site	Wadsworth	Ohio	United States	44281
31	GSK Investigational Site	Carnegie	Pennsylvania	United States	15106
32	GSK Investigational Site	Pleasant Hills	Pennsylvania	United States	15236
33	GSK Investigational Site	Uniontown	Pennsylvania	United States	15401
34	GSK Investigational Site	Greer	South Carolina	United States	29650
35	GSK Investigational Site	Mount Pleasant	South Carolina	United States	29464
36	GSK Investigational Site	Bristol	Tennessee	United States	37620
37	GSK Investigational Site	San Antonio	Texas	United States	78229
38	GSK Investigational Site	Murray	Utah	United States	84123
39	GSK Investigational Site	Arlington	Virginia	United States	22203
40	GSK Investigational Site	Norfolk	Virginia	United States	23502
41	GSK Investigational Site	Richmond	Virginia	United States	23294
42	GSK Investigational Site	Winchester	Virginia	United States	22601
43	GSK Investigational Site	Renton	Washington	United States	98057
44	GSK Investigational Site	Glebe	New South Wales	Australia	2037
45	GSK Investigational Site	Maroubra	New South Wales	Australia	2035
46	GSK Investigational Site	Umina	New South Wales	Australia	2257
47	GSK Investigational Site	Westmead	New South Wales	Australia	2145
48	GSK Investigational Site	Wollongong	New South Wales	Australia	2522
49	GSK Investigational Site	Caboolture	Queensland	Australia	4510
50	GSK Investigational Site	Kippa Ring	Queensland	Australia	4021
51	GSK Investigational Site	Geelong	Victoria	Australia	3220
52	GSK Investigational Site	Ivanhoe	Victoria	Australia	3079
53	GSK Investigational Site	Belo Horizonte	Minas Gerais	Brazil	30150-221
54	GSK Investigational Site	Curitiba/Paraná	Paraná	Brazil	80810-050
55	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035003
56	GSK Investigational Site	Curitiba/PR		Brazil	80240-280
57	GSK Investigational Site	São Paulo		Brazil	04038 002
58	GSK Investigational Site	São Paulo		Brazil	04266-010
59	GSK Investigational Site	São Paulo		Brazil	04312903
60	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 1M9
61	GSK Investigational Site	Victoria	British Columbia	Canada	V8V 3P9
62	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada	A0A 1G0
63	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
64	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2
65	GSK Investigational Site	Toronto	Ontario	Canada	M4S 1Y2
66	GSK Investigational Site	Toronto	Ontario	Canada	M9W 4L6
67	GSK Investigational Site	Woodstock	Ontario	Canada	N4S 5P5
68	GSK Investigational Site	Gatineau	Quebec	Canada	J8Y 6S8
69	GSK Investigational Site	Mirabel	Quebec	Canada	J7J 2K8
70	GSK Investigational Site	Pointe-Claire	Quebec	Canada	H9R 4S3
71	GSK Investigational Site	Quebec City	Quebec	Canada	G1E 7G9
72	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 2G2
73	GSK Investigational Site	Trois Rivières	Quebec	Canada	G8T 7A1
74	GSK Investigational Site	Quebec		Canada	G1W 4R4
75	GSK Investigational Site	Brno		Czechia	662 10
76	GSK Investigational Site	Ceske Budejovice		Czechia	370 04
77	GSK Investigational Site	Hradec Kralove		Czechia	500 01
78	GSK Investigational Site	Tallinn		Estonia	13619
79	GSK Investigational Site	Tartu		Estonia	50106
80	GSK Investigational Site	Espoo		Finland	02230
81	GSK Investigational Site	Helsinki		Finland	00100
82	GSK Investigational Site	Helsinki		Finland	00930
83	GSK Investigational Site	Jarvenpaa		Finland	04400
84	GSK Investigational Site	Kokkola		Finland	67100
85	GSK Investigational Site	Oulu		Finland	90220
86	GSK Investigational Site	Pori		Finland	28100
87	GSK Investigational Site	Seinajoki		Finland	60100
88	GSK Investigational Site	Tampere		Finland	33100
89	GSK Investigational Site	Turku		Finland	20520
90	GSK Investigational Site	Angers		France	49000
91	GSK Investigational Site	Cherbourg		France	50100
92	GSK Investigational Site	Château Gontier		France	53200
93	GSK Investigational Site	Clermont-Ferrand		France	63003
94	GSK Investigational Site	Laval		France	53000
95	GSK Investigational Site	Laval		France	53100
96	GSK Investigational Site	Montrevault		France	49110
97	GSK Investigational Site	Muret		France	31600
98	GSK Investigational Site	Nantes		France	44300
99	GSK Investigational Site	Rosiers d'Egletons		France	19300
100	GSK Investigational Site	Saint Cyr Sur Loir		France	37540
101	GSK Investigational Site	Segré		France	49500
102	GSK Investigational Site	Soulaines sur Aubance		France	49610
103	GSK Investigational Site	Tours		France	37100
104	GSK Investigational Site	Deggingen	Baden-Wuerttemberg	Germany	73326
105	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg	Germany	74363
106	GSK Investigational Site	Mannheim	Baden-Wuerttemberg	Germany	68161
107	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg	Germany	72074
108	GSK Investigational Site	Wangen	Baden-Wuerttemberg	Germany	88239
109	GSK Investigational Site	Weinheim	Baden-Wuerttemberg	Germany	69469
110	GSK Investigational Site	Dachau	Bayern	Germany	85221
111	GSK Investigational Site	Kuenzing	Bayern	Germany	94550
112	GSK Investigational Site	Muenchen	Bayern	Germany	80339
113	GSK Investigational Site	Rednitzhembach	Bayern	Germany	91126
114	GSK Investigational Site	Wallerfing	Bayern	Germany	94574
115	GSK Investigational Site	Wuerzburg	Bayern	Germany	97070
116	GSK Investigational Site	Potsdam	Brandenburg	Germany	14467
117	GSK Investigational Site	Floersheim	Hessen	Germany	65439
118	GSK Investigational Site	Frankfurt	Hessen	Germany	60389
119	GSK Investigational Site	Duelmen	Niedersachsen	Germany	48249
120	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45355
121	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45359
122	GSK Investigational Site	Goch	Nordrhein-Westfalen	Germany	47574
123	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	51069
124	GSK Investigational Site	Witten	Nordrhein-Westfalen	Germany	58455
125	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55116
126	GSK Investigational Site	Rhaunen	Rheinland-Pfalz	Germany	55624
127	GSK Investigational Site	Koethen	Sachsen-Anhalt	Germany	06366
128	GSK Investigational Site	Magdeburg	Sachsen-Anhalt	Germany	39112
129	GSK Investigational Site	Dresden	Sachsen	Germany	01097
130	GSK Investigational Site	Freiberg	Sachsen	Germany	09599
131	GSK Investigational Site	Leipzig	Sachsen	Germany	04315
132	GSK Investigational Site	Pirna	Sachsen	Germany	01796
133	GSK Investigational Site	Luebeck	Schleswig-Holstein	Germany	23554
134	GSK Investigational Site	Berlin		Germany	10629
135	GSK Investigational Site	Berlin		Germany	10717
136	GSK Investigational Site	Berlin		Germany	10787
137	GSK Investigational Site	Berlin		Germany	12157
138	GSK Investigational Site	Berlin		Germany	12351
139	GSK Investigational Site	Berlin		Germany	13347
140	GSK Investigational Site	Hamburg		Germany	20251
141	GSK Investigational Site	Hamburg		Germany	22143
142	GSK Investigational Site	Hamburg		Germany	22415
143	GSK Investigational Site	Kwun Tong		Hong Kong
144	GSK Investigational Site	Shatin		Hong Kong
145	GSK Investigational Site	Chieti	Abruzzo	Italy	66013
146	GSK Investigational Site	Pescara	Abruzzo	Italy	65100
147	GSK Investigational Site	Roma	Lazio	Italy	00163
148	GSK Investigational Site	Genova	Liguria	Italy	16132
149	GSK Investigational Site	Monza	Lombardia	Italy	20052
150	GSK Investigational Site	Cuneo	Piemonte	Italy	12100
151	GSK Investigational Site	Cagliari	Sardegna	Italy	09127
152	GSK Investigational Site	Sassari	Sardegna	Italy	07100
153	GSK Investigational Site	Catania	Sicilia	Italy	95129
154	GSK Investigational Site	Ragusa (RG)	Sicilia	Italy	97100
155	GSK Investigational Site	Fukuoka		Japan	810-0021
156	GSK Investigational Site	Fukuoka		Japan	812-0025
157	GSK Investigational Site	Fukuoka		Japan	813-8588
158	GSK Investigational Site	Fukuoka		Japan	816-0864
159	GSK Investigational Site	Kanagawa		Japan	224-8503
160	GSK Investigational Site	Kanagawa		Japan	247-8533
161	GSK Investigational Site	Kyoto		Japan	611-0041
162	GSK Investigational Site	Tokyo		Japan	141-0001
163	GSK Investigational Site	Tokyo		Japan	142-8666
164	GSK Investigational Site	Tokyo		Japan	154-0024
165	GSK Investigational Site	Ansan		Korea, Republic of	425-707
166	GSK Investigational Site	Bucheon-si,		Korea, Republic of	420-767
167	GSK Investigational Site	Incheon		Korea, Republic of	400-711
168	GSK Investigational Site	Kangnam-gu, Seoul		Korea, Republic of
169	GSK Investigational Site	Kangwon-do		Korea, Republic of	220-701
170	GSK Investigational Site	Seoul		Korea, Republic of	135-710
171	GSK Investigational Site	Seoul		Korea, Republic of	150-950
172	GSK Investigational Site	Seoul		Korea, Republic of	152-703
173	GSK Investigational Site	Zapopan, Jalisco	Jalisco	Mexico	45190
174	GSK Investigational Site	Cuernavaca	Morelos	Mexico	62210
175	GSK Investigational Site	Durango		Mexico	34000
176	GSK Investigational Site	Monterrey		Mexico
177	GSK Investigational Site	Alcover( Tarragona)		Spain	43460
178	GSK Investigational Site	Balenyà (Barcelona)		Spain	08550
179	GSK Investigational Site	Barcelona		Spain	08025
180	GSK Investigational Site	Barcelona		Spain	08035
181	GSK Investigational Site	Centelles		Spain
182	GSK Investigational Site	La Roca Del Valles (Barcelona)		Spain	08430
183	GSK Investigational Site	Madrid		Spain	28040
184	GSK Investigational Site	Madrid		Spain	28046
185	GSK Investigational Site	Majadahonda		Spain
186	GSK Investigational Site	Peralada( Girona)		Spain	17491
187	GSK Investigational Site	Valencia		Spain	46020
188	GSK Investigational Site	Vic/ Barcelona		Spain	08500
189	GSK Investigational Site	Borås		Sweden	SE-506 30
190	GSK Investigational Site	Eskilstuna		Sweden	SE-631 88
191	GSK Investigational Site	Göteborg		Sweden	SE-413 45
192	GSK Investigational Site	Jönköping		Sweden	SE-551 85
193	GSK Investigational Site	Karlskrona		Sweden	SE-371 41
194	GSK Investigational Site	Linköping		Sweden	SE-58758
195	GSK Investigational Site	Malmö		Sweden	SE-211 52
196	GSK Investigational Site	Skövde		Sweden	SE-541 85
197	GSK Investigational Site	Stockholm		Sweden	SE-111 57
198	GSK Investigational Site	Uppsala		Sweden	SE-751 85
199	GSK Investigational Site	Vällingby		Sweden	SE-162 68
200	GSK Investigational Site	Örebro		Sweden	SE-703 62
201	GSK Investigational Site	Taichung		Taiwan	40447
202	GSK Investigational Site	Taipei		Taiwan	112
203	GSK Investigational Site	Taipei		Taiwan
204	GSK Investigational Site	Taoyuan		Taiwan	333
205	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire	United Kingdom	PR7 7NA
206	GSK Investigational Site	Atherstone	Warwickshire	United Kingdom	CV9 1EU
207	GSK Investigational Site	Bradford on Avon	Wiltshire	United Kingdom	BA15 1DQ
208	GSK Investigational Site	Bangor		United Kingdom	BT19 1PP
209	GSK Investigational Site	Belfast		United Kingdom	BT7 2EB
210	GSK Investigational Site	Broughshane		United Kingdom	BT42 4JP
211	GSK Investigational Site	Ledbury		United Kingdom	HR8 2AA
212	GSK Investigational Site	Newtonabbey		United Kingdom	BT37 9QW
213	GSK Investigational Site	Waterloo, Liverpool		United Kingdom	L22 0LG

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.
• Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Díez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barberà J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.
• Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.
• Kovac M, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01165229
• Other Study ID Numbers: 113077; 2009-015791-94
• First Posted: Jul 19, 2010
• Last Update Posted: Apr 27, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Immunogenicity; Subjects 70 years and older; Efficacy; Herpes Zoster; Safety; Adults; Vaccine
• Additional relevant MeSH terms: Herpes Simplex; Herpes Zoster

Study Results

Participant Flow

Pre-assignment Detail	Only 13900 subjects from the total enrolled number were vaccinated and included in the Total Vaccinated Cohort. In the placebo group,1 subject had an unknown withdrawal status before the study site closure. This was not identified during database freeze, leading to 1190 subjects in place of 1189 that actually completed the placebo group

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Period Title: Overall Study
STARTED	6950	6950
COMPLETED	5770	5760
NOT COMPLETED	1180	1190

Baseline Characteristics

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group	Total
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Total of all reporting groups
Overall Participants	6950	6950	13900
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	75.6 (4.7)	75.6 (4.7)	75.6 (4.7)
Sex: Female, Male (Count of Participants)
Female	3789 54.5%	3836 55.2%	7625 54.9%
Male	3161 45.5%	3114 44.8%	6275 45.1%
Race/Ethnicity, Customized (Count of Participants)
African Heritage / African American	79 1.1%	67 1%	146 1.1%
American Indian or Alaskan Native	1 0%	8 0.1%	9 0.1%
Asian - Central/South Asian Heritage	3 0%	6 0.1%	9 0.1%
Asian - East Asian Heritage	907 13.1%	908 13.1%	1815 13.1%
Asian - Japanese Heritage	298 4.3%	300 4.3%	598 4.3%
Asian - South East Asian Heritage	8 0.1%	4 0.1%	12 0.1%
Native Hawaiian or Other Pacific Islander	3 0%	3 0%	6 0%
White - Arabic / North African Heritage	40 0.6%	47 0.7%	87 0.6%
White - Caucasian / European Heritage	5307 76.4%	5301 76.3%	10608 76.3%
Other	304 4.4%	306 4.4%	610 4.4%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Any Episodes of Herpes Zoster (HZ)
Description	Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	5114	1427	6541	5189	1433	6622
Count of Participants [Participants]	17 0.2%	6 0.1%	23 0.2%	169 NaN	54 NaN	223 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.
	Type of Statistical Test	Other
	Comments	The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	90.02
	Confidence Interval	(2-Sided) 95%; 83.54 to 94.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact method
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	89.08
	Confidence Interval	(2-Sided) 95%; 74.65 to 96.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	89.79
	Confidence Interval	(2-Sided) 95%; 84.29 to 93.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
Description	Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A 70-79YOA Group	Zoster-022/006 Pooled GSK1437173A >=80YOA Group	Zoster-022/006 Pooled GSK1437173A >=70YOA Group	Zoster-022/006 Pooled Placebo 70-79YOA Group	Zoster-022/006 Pooled Placebo >=80YOA Group	Zoster-022/006 Pooled Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6468	1782	8250	6554	1792	8346
Count of Participants [Participants]	2 0%	2 0%	4 0%	29 NaN	7 NaN	36 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	93.04
	Confidence Interval	(2-Sided) 95%; 72.47 to 99.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A >=80YOA Group and Zoster-022/006 Pooled Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	0.1844
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	71.16
	Confidence Interval	(2-Sided) 95%; -51.51 to 97.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A >=70YOA Group and Zoster-022/006 Pooled Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	88.78
	Confidence Interval	(2-Sided) 95%; 68.70 to 97.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
Description	Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A 70-79YOA Group	Zoster-022/006 Pooled GSK1437173A >=80YOA Group	Zoster-022/006 Pooled GSK1437173A >=70YOA Group	Zoster-022/006 Pooled Placebo 70-79YOA Group	Zoster-022/006 Pooled Placebo >=80YOA Group	Zoster-022/006 Pooled Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6468	1782	8250	6554	1792	8346
Count of Participants [Participants]	19 0.3%	6 0.1%	25 0.2%	216 NaN	68 NaN	284 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	91.27
	Confidence Interval	(2-Sided) 95%; 86.04 to 94.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A >=80YOA Group and Zoster-022/006 Pooled Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	91.37
	Confidence Interval	(2-Sided) 95%; 80.22 to 96.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A >=70 YOA Group and Zoster-022/006 Pooled Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	91.30
	Confidence Interval	(2-Sided) 95%; 86.88 to 94.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Subjects With Post-herpetic Neuralgia (PHN)
Description	PHN cases in the mTVc.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	5114	1427	6541	5189	1433	6622
Count of Participants [Participants]	2 0%	2 0%	4 0%	22 NaN	6 NaN	28 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	90.80
	Confidence Interval	(2-Sided) 95%; 62.57 to 98.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	0.3072
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	65.76
	Confidence Interval	(2-Sided) 95%; -91.58 to 96.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	85.49
	Confidence Interval	(2-Sided) 95%; 58.52 to 96.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Days With Severe 'Worst' HZ-associated Pain
Description	Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	15	3	18	150	48	198
Mean (Standard Deviation) [Days]	21.8 (31.41)	98.7 (57.73)	34.6 (45.54)	47.9 (100.08)	50.4 (106.51)	48.5 (101.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.3749
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	21.70
	Confidence Interval	(2-Sided) 95%; -34.40 to 54.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo>=80YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.2466
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	51.76
	Confidence Interval	(2-Sided) 95%; -65.55 to 85.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo>=70YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.1877
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	28.40
	Confidence Interval	(2-Sided) 95%; -17.69 to 56.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
Description	The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	5114	1427	6541	5189	1433	6622
Mortality	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Hospitalization	0 0%	0 0%	0 0%	3 NaN	2 NaN	5 NaN
Mortality or hospitalization	0 0%	0 0%	0 0%	3 NaN	2 NaN	5 NaN

7. Secondary Outcome

Title	Number of Subjects With Overall Mortality and HZ-related Mortality
Description	The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	5114	1427	6541	5189	1433	6622
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN

8. Secondary Outcome

Title	Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Description	Incidence of overall and HZ-related hospitalizations during the study.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	5114	1427	6541	5189	1433	6622
Count of Participants [Participants]	0 0%	0 0%	0 0%	3 NaN	2 NaN	5 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.
Statistical Test of Hypothesis	p-Value	0.2533
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -144.13 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.
Statistical Test of Hypothesis	p-Value	0.5024
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -435.14 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.
Statistical Test of Hypothesis	p-Value	0.0636
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -9.92 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Number of Subjects With HZ Related Complications
Description	Incidence of HZ complications during the study in subjects with confirmed HZ.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	17	6	23	169	54	223
At least one complication	1 0%	0 0%	1 0%	6 NaN	4 NaN	10 NaN
HZ vasculitis	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Disseminated Disease	0 0%	0 0%	0 0%	0 NaN	2 NaN	2 NaN
Ophthalmic Disease	1 0%	0 0%	1 0%	4 NaN	2 NaN	6 NaN
Neurologic Disease	0 0%	0 0%	0 0%	3 NaN	0 NaN	3 NaN
Visceral Disease	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Stroke	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.
Statistical Test of Hypothesis	p-Value	0.4947
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	-65.69
	Confidence Interval	(2-Sided) 95%; -827.06 to 73.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -558.05 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; -433.32 to 83.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Number of Subjects Receiving Pain Medication Associated With HZ
Description	Incidence of use of pain medications throughout the study
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	17	6	23	169	54	223
At least 1 pain medication	7 0.1%	3 0%	10 0.1%	123 NaN	37 NaN	160 NaN
1 pain medication only	5 0.1%	0 0%	5 0%	43 NaN	17 NaN	60 NaN
2 pain medications only	0 0%	1 0%	1 0%	30 NaN	4 NaN	34 NaN
3 pain medications or more	2 0%	2 0%	4 0%	50 NaN	16 NaN	66 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.
Statistical Test of Hypothesis	p-Value	0.0112
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	43.42
	Confidence Interval	(2-Sided) 95%; 10.77 to 70.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%
Statistical Test of Hypothesis	p-Value	0.3903
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	27.03
	Confidence Interval	(2-Sided) 95%; -26.43 to 73.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A >=70YOA group and Zoster-022 Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.
Statistical Test of Hypothesis	p-Value	0.0083
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	39.60
	Confidence Interval	(2-Sided) 95%; 10.79 to 64.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Number of Days With Pain Medication Associated With HZ
Description	Incidence of reduction of duration of pain medication associated with HZ throughout the study.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022 GSK1437173A 70-79YOA Group	Zoster-022 GSK1437173A >=80YOA Group	Zoster-022 GSK1437173A >=70YOA Group	Zoster-022 Placebo 70-79YOA Group	Zoster-022 Placebo >=80YOA Group	Zoster-022 Placebo >=70YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	7	3	10	123	37	160
Mean (Standard Deviation) [Days]	38.7 (56.44)	274.7 (337.00)	109.5 (200.88)	218.6 (593.80)	135.0 (207.31)	199.3 (530.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.0232
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	58.94
	Confidence Interval	(2-Sided) 95%; 11.45 to 80.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.8324
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	-14.56
	Confidence Interval	(2-Sided) 95%; -303.30 to 67.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group
	Type of Statistical Test	Other
	Comments	Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.0404
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	49.25
	Confidence Interval	(2-Sided) 95%; 2.92 to 73.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame	Within 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 - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	505	505
Any Pain, Dose 1	297 4.3%	26 0.4%
Grade 3 Pain, Dose 1	12 0.2%	1 0%
Any Redness, Dose 1	143 2.1%	3 0%
Grade 3 Redness, Dose 1	9 0.1%	0 0%
Any Swelling, Dose 1	85 1.2%	2 0%
Grade 3 Swelling, Dose 1	2 0%	0 0%
Any Pain, Dose 2	282 4.1%	23 0.3%
Grade 3 Pain, Dose 2	12 0.2%	0 0%
Any Redness, Dose 2	137 2%	3 0%
Grade 3 Redness, Dose 2	15 0.2%	0 0%
Any Swelling, Dose 2	68 1%	0 0%
Grade 3 Swelling, Dose 2	7 0.1%	0 0%
Any Pain, Across Doses	347 5%	43 0.6%
Grade 3 Pain, Across Doses	22 0.3%	1 0%
Any Redness, Across Doses	198 2.8%	5 0.1%
Grade 3 Redness, Across Doses	20 0.3%	0 0%
Any Swelling, Across Doses	114 1.6%	2 0%
Grade 3 Swelling, Across Doses	8 0.1%	0 0%

13. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	Within 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 - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	504	505
Any Fatigue, Dose 1	104 1.5%	56 0.8%
Grade 3 Fatigue, Dose 1	8 0.1%	4 0.1%
Related Fatigue, Dose 1	85 1.2%	34 0.5%
Any Gastrointestinal, Dose 1	25 0.4%	28 0.4%
Grade 3 Gastrointestinal, Dose 1	3 0%	2 0%
Related Gastrointestinal, Dose 1	16 0.2%	14 0.2%
Any Headache, Dose 1	72 1%	42 0.6%
Grade 3 Headache, Dose 1	2 0%	4 0.1%
Related Headache, Dose 1	58 0.8%	27 0.4%
Any Myalgia, Dose 1	106 1.5%	27 0.4%
Grade 3 Myalgia, Dose 1	6 0.1%	2 0%
Related Myalgia, Dose 1	91 1.3%	16 0.2%
Any Shivering, Dose 1	38 0.5%	17 0.2%
Grade 3 Shivering, Dose 1	1 0%	1 0%
Related Shivering, Dose 1	32 0.5%	12 0.2%
Any Temperature, Dose 1	39 0.6%	9 0.1%
Grade 3 Temperature, Dose 1	0 0%	2 0%
Related Temperature, Dose 1	31 0.4%	4 0.1%
Any Fatigue, Dose 2	122 1.8%	39 0.6%
Grade 3 Fatigue, Dose 2	9 0.1%	0 0%
Related Fatigue, Dose 2	105 1.5%	30 0.4%
Any Gastrointestinal, Dose 2	37 0.5%	19 0.3%
Grade 3 Gastrointestinal, Dose 2	3 0%	1 0%
Related Gastrointestinal, Dose 2	26 0.4%	13 0.2%
Any Headache, Dose 2	76 1.1%	26 0.4%
Grade 3 Headache, Dose 2	4 0.1%	0 0%
Related Headache, Dose 2	63 0.9%	20 0.3%
Any Myalgia, Dose 2	113 1.6%	18 0.3%
Grade 3 Myalgia, Dose 2	7 0.1%	0 0%
Related Myalgia, Dose 2	94 1.4%	16 0.2%
Any Shivering, Dose 2	59 0.8%	11 0.2%
Grade 3 Shivering, Dose 2	5 0.1%	1 0%
Related Shivering, Dose 2	47 0.7%	9 0.1%
Any Temperature, Dose 2	38 0.5%	6 0.1%
Grade 3 Temperature, Dose 2	0 0%	2 0%
Related Temperature, Dose 2	35 0.5%	2 0%
Any Fatigue, Across Doses	166 2.4%	77 1.1%
Grade 3 Fatigue, Across Doses	16 0.2%	4 0.1%
Related Fatigue, Across Doses	140 2%	52 0.7%
Any Gastrointestinal, Across Doses	55 0.8%	40 0.6%
Grade 3 Gastrointestinal, Across Doses	5 0.1%	2 0%
Related Gastrointestinal, Across Doses	38 0.5%	21 0.3%
Any Headache, Across Doses	124 1.8%	55 0.8%
Grade 3 Headache, Across Doses	5 0.1%	4 0.1%
Related Headache, Across Doses	104 1.5%	37 0.5%
Any Myalgia, Across Doses	157 2.3%	41 0.6%
Grade 3 Myalgia, Across Doses	12 0.2%	2 0%
Related Myalgia, Across Doses	137 2%	29 0.4%
Any Shivering, Across Doses	75 1.1%	22 0.3%
Grade 3 Shivering, Across Doses	6 0.1%	2 0%
Related Shivering, Across Doses	64 0.9%	16 0.2%
Any Temperature, Across Doses	62 0.9%	13 0.2%
Grade 3 Temperature, Across Doses	0 0%	2 0%
Related Temperature, Across Doses	54 0.8%	6 0.1%

14. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description	Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. 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	Within the 30 days (Days 0-29) after each vaccination

Outcome Measure Data

Analysis Population Description

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6950	6950
Any unsolicited AE(s)	3859 55.5%	2263 32.6%
Grade 3 unsolicited AE(s)	485 7%	265 3.8%
Related unsolicited AE(s)	2853 41.1%	529 7.6%

15. Secondary Outcome

Title	Number of Subjects With Any and Related 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 14

Outcome Measure Data

Analysis Population Description

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6950	6950
Any SAE(s)	891 12.8%	939 13.5%
Related SAE(s)	12 0.2%	7 0.1%

16. Secondary Outcome

Title	Number of Subjects With Fatal 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	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6950	6950
Count of Participants [Participants]	426 6.1%	459 6.6%

17. Secondary Outcome

Title	Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication
Description	The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated
Time Frame	During the entire study period (3 to 5 year period following day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6950	6950
Count of Participants [Participants]	57 0.8%	84 1.2%

18. Secondary Outcome

Title	Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Description	Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6950	6950
Any pIMD	92 1.3%	97 1.4%
Related pIMDs	8 0.1%	6 0.1%

19. Secondary Outcome

Title	Number of Subjects With Any and Related Medically Attended Visits
Description	Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.
Time Frame	From Month 0 to Month 8 post-vaccination

Outcome Measure Data

Analysis Population Description

This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.

Arm/Group Title	Zoster-022 GSK1437173A Group	Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	6950	6950
Any medically attended visits	2882 41.5%	2911 41.9%
Related medically attended visits	165 2.4%	66 0.9%

20. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA
Description	Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group	Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Zoster-022/006 Pooled GSK1437173A >=80 YOA Group	Zoster-022/006 Pooled GSK1437173A >=50 YOA Group	Zoster-022/006 Pooled Placebo 50-59 YOA Group	Zoster-022/006 Pooled Placebo 60-69 YOA Group	Zoster-022/006 Pooled Placebo 70-79 YOA Group	Zoster-022/006 Pooled Placebo >=80 YOA Group	Zoster-022/006 Pooled Placebo >=50 YOA Group
Arm/Group Description	Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	3491	2140	6468	1782	13881	3523	2166	6554	1792	14035
Count of Participants [Participants]	0 0%	0 0%	2 0%	2 NaN	4 NaN	8 NaN	2 NaN	29 NaN	7 NaN	46 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	0.0081
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; 40.88 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022/006 Pooled Placebo 60-69 YOA Group
	Comments	Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	0.5097
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -442.83 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ
Description	Occurrence of PHN during the entire study period in all subjects with confirmed HZ.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group	Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Zoster-022/006 Pooled GSK1437173A >=80 YOA Group	Zoster-022/006 Pooled GSK1437173A >=50 YOA Group	Zoster-022/006 Pooled Placebo 50-59 YOA Group	Zoster-022/006 Pooled Placebo 60-69 YOA Group	Zoster-022/006 Pooled Placebo 70-79 YOA Group	Zoster-022/006 Pooled Placebo >=80 YOA Group	Zoster-022/006 Pooled Placebo >=50 YOA Group
Arm/Group Description	Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 50 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 50 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	4	3	19	6	32	103	90	216	68	477
Count of Participants [Participants]	0 0%	0 0%	2 0%	2 NaN	4 NaN	8 NaN	2 NaN	29 NaN	7 NaN	46 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -649.86 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022/006 Pooled Placebo 60-69 YOA Group
	Comments	Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -3938.70 to 100.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022/006 Pooled Placebo 70-79 YOA Group
	Comments	Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	21.60
	Confidence Interval	(2-Sided) 95%; -149.41 to 78.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 Placebo 70-79YOA Group, Zoster-022/006 Pooled Placebo >=80 YOA Group
	Comments	Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A >=80 YOA Group versus Zoster-022/006 Pooled Placebo>=80 YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	0.1528
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	-223.81
	Confidence Interval	(2-Sided) 95%; -883.05 to 18.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 Placebo >=80YOA Group, Zoster-022/006 Pooled Placebo >=50 YOA Group
	Comments	Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A >=50 YOA Group versus Zoster-022/006 Pooled Placebo >=50 YOA Group
	Type of Statistical Test	Other
	Comments	The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%
Statistical Test of Hypothesis	p-Value	0.5417
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 95%; -161.53 to 65.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.
Description	The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Zoster-022/006 Pooled GSK1437173A >=80 YOA Group	Zoster-022/006 Pooled GSK1437173A >=70 YOA Group	Zoster-022/006 Pooled Placebo 70-79 YOA Group	Zoster-022/006 Pooled Placebo >=80 YOA Group	Zoster-022/006 Pooled Placebo >=70 YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	19	6	25	216	68	284
Count of Participants [Participants]	17 0.2%	3 0%	20 0.1%	193 NaN	61 NaN	254 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A 70-79YOA Group, Zoster-022 Placebo 70-79YOA Group
	Comments	Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group
	Type of Statistical Test	Other
	Comments	The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.2885
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	23.75
	Confidence Interval	(2-Sided) 95%; -25.80 to 53.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=80YOA Group, Zoster-022 Placebo >=80YOA Group
	Comments	Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A >=80 YOA Group and Zoster-022/006 pooled Placebo >=80 YOA Group
	Type of Statistical Test	Other
	Comments	The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.1940
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	54.93
	Confidence Interval	(2-Sided) 95%; -50.03 to 86.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Zoster-022 GSK1437173A >=70YOA Group, Zoster-022 Placebo >=70YOA Group
	Comments	Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A >=70 YOA Group and Zoster-022/006 pooled Placebo>=70 YOA Group
	Type of Statistical Test	Other
	Comments	The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.
Statistical Test of Hypothesis	p-Value	0.1243
	Comments
	Method	Poisson exact test
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	30.48
	Confidence Interval	(2-Sided) 95%; -10.52 to 56.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.
Description	Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group	Zoster-022/006 Pooled GSK1437173A >=80 YOA Group	Zoster-022/006 Pooled GSK1437173A >=70 YOA Group	Zoster-022/006 Pooled Placebo 70-79 YOA Group	Zoster-022/006 Pooled Placebo >=80 YOA Group	Zoster-022/006 Pooled Placebo >=70 YOA Group
Arm/Group Description	Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.	Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	17	3	20	193	61	254
Mean (Standard Deviation) [Days]	20.3 (29.71)	98.7 (57.73)	32.1 (43.80)	48.3 (96.34)	45.2 (95.58)	47.5 (95.98)

24. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. 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	Within 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 - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	2258	2263
Any Pain, Dose 1	1336 19.2%	128 1.8%
Grade 3 Pain, Dose 1	42 0.6%	1 0%
Any Redness, Dose 1	606 8.7%	17 0.2%
Grade 3 Redness, Dose 1	43 0.6%	0 0%
Any Swelling, Dose 1	355 5.1%	17 0.2%
Grade 3 Swelling, Dose 1	17 0.2%	0 0%
Any Pain, Dose 2	1241 17.9%	107 1.5%
Grade 3 Pain, Dose 2	60 0.9%	3 0%
Any Redness, Dose 2	582 8.4%	14 0.2%
Grade 3 Redness, Dose 2	39 0.6%	0 0%
Any Swelling, Dose 2	344 4.9%	10 0.1%
Grade 3 Swelling, Dose 2	15 0.2%	0 0%
Any Pain, Across Doses	1562 22.5%	199 2.9%
Grade 3 Pain, Across Doses	90 1.3%	4 0.1%
Any Redness, Across Doses	851 12.2%	27 0.4%
Grade 3 Redness, Across Doses	70 1%	0 0%
Any Swelling, Across Doses	519 7.5%	25 0.4%
Grade 3 Swelling, Across Doses	30 0.4%	0 0%

25. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	Within 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 - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	2252	2264
Any Fatigue, Dose 1	545 7.8%	231 3.3%
Grade 3 Fatigue, Dose 1	31 0.4%	13 0.2%
Related Fatigue, Dose 1	441 6.3%	147 2.1%
Any Gastrointestinal, Dose 1	170 2.4%	123 1.8%
Grade 3 Gastrointestinal, Dose 1	15 0.2%	6 0.1%
Related Gastrointestinal, Dose 1	101 1.5%	67 1%
Any Headache, Dose 1	380 5.5%	189 2.7%
Grade 3 Headache, Dose 1	7 0.1%	8 0.1%
Related Headache, Dose 1	293 4.2%	132 1.9%
Any Myalgia, Dose 1	530 7.6%	159 2.3%
Grade 3 Myalgia, Dose 1	26 0.4%	7 0.1%
Related Myalgia, Dose 1	445 6.4%	101 1.5%
Any Shivering, Dose 1	206 3%	73 1.1%
Grade 3 Shivering, Dose 1	15 0.2%	3 0%
Related Shivering, Dose 1	173 2.5%	50 0.7%
Any Temperature, Dose 1	142 2%	34 0.5%
Grade 3 Temperature, Dose 1	1 0%	2 0%
Related Temperature, Dose 1	111 1.6%	16 0.2%
Any Fatigue, Dose 2	579 8.3%	169 2.4%
Grade 3 Fatigue, Dose 2	53 0.8%	4 0.1%
Related Fatigue, Dose 2	495 7.1%	116 1.7%
Any Gastrointestinal, Dose 2	188 2.7%	75 1.1%
Grade 3 Gastrointestinal, Dose 2	14 0.2%	5 0.1%
Related Gastrointestinal, Dose 2	142 2%	35 0.5%
Any Headache, Dose 2	455 6.5%	133 1.9%
Grade 3 Headache, Dose 2	30 0.4%	2 0%
Related Headache, Dose 2	386 5.6%	86 1.2%
Any Myalgia, Dose 2	560 8.1%	112 1.6%
Grade 3 Myalgia, Dose 2	42 0.6%	4 0.1%
Related Myalgia, Dose 2	484 7%	75 1.1%
Any Shivering, Dose 2	334 4.8%	55 0.8%
Grade 3 Shivering, Dose 2	36 0.5%	4 0.1%
Related Shivering, Dose 2	292 4.2%	34 0.5%
Any Temperature, Dose 2	224 3.2%	30 0.4%
Grade 3 Temperature, Dose 2	2 0%	3 0%
Related Temperature, Dose 2	189 2.7%	14 0.2%
Any Fatigue, Across Doses	825 11.9%	326 4.7%
Grade 3 Fatigue, Across Doses	79 1.1%	17 0.2%
Related Fatigue, Across Doses	699 10.1%	220 3.2%
Any Gastrointestinal, Across Doses	304 4.4%	172 2.5%
Grade 3 Gastrointestinal,Across Doses	26 0.4%	10 0.1%
Related Gastrointestinal,Across Doses	210 3%	91 1.3%
Any Headache, Across Doses	653 9.4%	268 3.9%
Grade 3 Headache, Across Doses	34 0.5%	10 0.1%
Related Headache, Across Doses	547 7.9%	185 2.7%
Any Myalgia, Across Doses	790 11.4%	225 3.2%
Grade 3 Myalgia, Across Doses	62 0.9%	10 0.1%
Related Myalgia, Across Doses	689 9.9%	157 2.3%
Any Shivering, Across Doses	439 6.3%	110 1.6%
Grade 3 Shivering, Across Doses	49 0.7%	6 0.1%
Related Shivering, Across Doses	380 5.5%	75 1.1%
Any Temperature, Across Doses	323 4.6%	61 0.9%
Grade 3 Temperature, Across Doses	3 0%	3 0%
Related Temperature, Across Doses	265 3.8%	30 0.4%

26. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA
Description	Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.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	Within 30 days (Days 0 - 29) after each vaccination

Outcome Measure Data

Analysis Population Description

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	8758	8773
Any unsolicited AE(s)	4366 62.8%	2732 39.3%
Grade 3 unsolicited AE(s)	553 8%	335 4.8%
Related unsolicited AE(s)	2961 42.6%	578 8.3%

27. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs
Description	Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.
Time Frame	From Month 0 to Month 14

Outcome Measure Data

Analysis Population Description

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	8758	8773
Any SAE(s)	1117 16.1%	1171 16.8%
Related SAE(s)	12 0.2%	7 0.1%

28. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
Description	Fatal SAEs during the entire study period in subjects ≥ 70 YOA.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	8758	8773
Count of Participants [Participants]	128 1.8%	144 2.1%

29. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs
Description	Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.
Time Frame	During the entire study period (3 to 5 year period following Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	8758	8773
Any pIMD(s)	110 1.6%	118 1.7%
Related pIMD(s)	8 0.1%	8 0.1%

30. Secondary Outcome

Title	Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits
Description	Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.
Time Frame	From Month 0 to Month 8 post-vaccination

Outcome Measure Data

Analysis Population Description

The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.

Arm/Group Title	Zoster-022/006 Pooled GSK1437173A Group	Zoster-022/006 Pooled Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.	Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Measure Participants	8758	8773
Any medically attended visits	3593 51.7%	3648 52.5%
Related medically attended visits	180 2.6%	80 1.2%

Adverse Events

Time Frame	Solicited symptoms: within 7 days (Days 0-6) after vaccination; Unsolicited adverse events: within 30 days (Days 0-29) after vaccination; Serious Adverse Events (SAEs): during the entire study period (3 to 5 year period following Day 0).
Arm/Group Title	Zoster-022 GSK1437173A Group		Zoster-022 Placebo Group
Arm/Group Description	Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.		Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
All Cause Mortality
	Zoster-022 GSK1437173A Group		Zoster-022 Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	426/6950 (6.1%)		459/6950 (6.6%)
Serious Adverse Events
	Zoster-022 GSK1437173A Group		Zoster-022 Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1153/6950 (16.6%)		1214/6950 (17.5%)
Blood and lymphatic system disorders
Anaemia	6/6950 (0.1%)	6	13/6950 (0.2%)	15
Anaemia vitamin b12 deficiency	1/6950 (0%)	1	0/6950 (0%)	0
Coagulopathy	0/6950 (0%)	0	2/6950 (0%)	2
Disseminated intravascular coagulation	1/6950 (0%)	1	1/6950 (0%)	1
Haemorrhagic anaemia	1/6950 (0%)	1	1/6950 (0%)	1
Hypersplenism	0/6950 (0%)	0	1/6950 (0%)	1
Immune thrombocytopenic purpura	1/6950 (0%)	1	0/6950 (0%)	0
Iron deficiency anaemia	5/6950 (0.1%)	5	4/6950 (0.1%)	4
Lymphadenitis	1/6950 (0%)	1	0/6950 (0%)	0
Lymphadenopathy	1/6950 (0%)	1	1/6950 (0%)	1
Microcytic anaemia	0/6950 (0%)	0	1/6950 (0%)	1
Nephrogenic anaemia	1/6950 (0%)	1	0/6950 (0%)	0
Normochromic normocytic anaemia	0/6950 (0%)	0	1/6950 (0%)	1
Pancytopenia	1/6950 (0%)	1	0/6950 (0%)	0
Pernicious anaemia	1/6950 (0%)	1	0/6950 (0%)	0
Thrombocytopenia	0/6950 (0%)	0	3/6950 (0%)	3
Cardiac disorders
Acute coronary syndrome	3/6950 (0%)	3	4/6950 (0.1%)	6
Acute left ventricular failure	0/6950 (0%)	0	1/6950 (0%)	1
Acute myocardial infarction	21/6950 (0.3%)	22	28/6950 (0.4%)	29
Angina pectoris	13/6950 (0.2%)	13	6/6950 (0.1%)	6
Angina unstable	7/6950 (0.1%)	7	7/6950 (0.1%)	7
Aortic valve disease	1/6950 (0%)	1	0/6950 (0%)	0
Aortic valve incompetence	0/6950 (0%)	0	1/6950 (0%)	1
Aortic valve stenosis	1/6950 (0%)	1	3/6950 (0%)	3
Arrhythmia	5/6950 (0.1%)	5	9/6950 (0.1%)	9
Arrhythmia supraventricular	0/6950 (0%)	0	1/6950 (0%)	1
Arteriosclerosis coronary artery	1/6950 (0%)	1	3/6950 (0%)	3
Atrial fibrillation	40/6950 (0.6%)	45	54/6950 (0.8%)	56
Atrial flutter	6/6950 (0.1%)	6	5/6950 (0.1%)	5
Atrioventricular block	0/6950 (0%)	0	4/6950 (0.1%)	4
Atrioventricular block complete	4/6950 (0.1%)	4	2/6950 (0%)	2
Atrioventricular block first degree	1/6950 (0%)	1	1/6950 (0%)	1
Atrioventricular block second degree	1/6950 (0%)	1	3/6950 (0%)	3
Bradyarrhythmia	1/6950 (0%)	1	1/6950 (0%)	1
Bradycardia	4/6950 (0.1%)	4	8/6950 (0.1%)	8
Cardiac arrest	23/6950 (0.3%)	23	17/6950 (0.2%)	17
Cardiac disorder	0/6950 (0%)	0	1/6950 (0%)	1
Cardiac failure	51/6950 (0.7%)	52	57/6950 (0.8%)	62
Cardiac failure acute	0/6950 (0%)	0	1/6950 (0%)	1
Cardiac failure chronic	3/6950 (0%)	3	6/6950 (0.1%)	6
Cardiac failure congestive	23/6950 (0.3%)	23	33/6950 (0.5%)	37
Cardiac tamponade	1/6950 (0%)	1	0/6950 (0%)	0
Cardiac valve disease	2/6950 (0%)	2	1/6950 (0%)	1
Cardio-respiratory arrest	3/6950 (0%)	3	5/6950 (0.1%)	5
Cardiogenic shock	6/6950 (0.1%)	6	2/6950 (0%)	2
Cardiomegaly	0/6950 (0%)	0	2/6950 (0%)	2
Cardiomyopathy	1/6950 (0%)	1	2/6950 (0%)	2
Cardiopulmonary failure	0/6950 (0%)	0	2/6950 (0%)	2
Chronotropic incompetence	0/6950 (0%)	0	1/6950 (0%)	1
Congestive cardiomyopathy	2/6950 (0%)	2	1/6950 (0%)	1
Cor pulmonale	1/6950 (0%)	1	0/6950 (0%)	0
Coronary artery disease	28/6950 (0.4%)	29	25/6950 (0.4%)	25
Coronary artery insufficiency	2/6950 (0%)	2	0/6950 (0%)	0
Coronary artery occlusion	1/6950 (0%)	1	0/6950 (0%)	0
Coronary artery stenosis	3/6950 (0%)	3	6/6950 (0.1%)	6
Diastolic dysfunction	0/6950 (0%)	0	1/6950 (0%)	1
Extrasystoles	2/6950 (0%)	2	0/6950 (0%)	0
Heart valve incompetence	0/6950 (0%)	0	2/6950 (0%)	2
Hypertensive heart disease	0/6950 (0%)	0	1/6950 (0%)	1
Ischaemic cardiomyopathy	0/6950 (0%)	0	4/6950 (0.1%)	4
Left ventricular failure	1/6950 (0%)	1	0/6950 (0%)	0
Left ventricular hypertrophy	1/6950 (0%)	1	0/6950 (0%)	0
Mitral valve incompetence	2/6950 (0%)	2	3/6950 (0%)	3
Myocardial infarction	41/6950 (0.6%)	43	45/6950 (0.6%)	45
Myocardial ischaemia	5/6950 (0.1%)	6	16/6950 (0.2%)	16
Palpitations	1/6950 (0%)	1	3/6950 (0%)	3
Pericarditis	1/6950 (0%)	1	0/6950 (0%)	0
Right ventricular failure	2/6950 (0%)	2	1/6950 (0%)	1
Sinus arrest	0/6950 (0%)	0	1/6950 (0%)	1
Sinus node dysfunction	5/6950 (0.1%)	5	6/6950 (0.1%)	6
Sinus tachycardia	0/6950 (0%)	0	1/6950 (0%)	1
Supraventricular tachycardia	3/6950 (0%)	3	0/6950 (0%)	0
Tachyarrhythmia	0/6950 (0%)	0	1/6950 (0%)	1
Tachycardia	3/6950 (0%)	3	2/6950 (0%)	2
Tricuspid valve incompetence	2/6950 (0%)	2	0/6950 (0%)	0
Ventricular arrhythmia	1/6950 (0%)	1	0/6950 (0%)	0
Ventricular extrasystoles	1/6950 (0%)	1	1/6950 (0%)	1
Ventricular fibrillation	2/6950 (0%)	2	3/6950 (0%)	3
Ventricular tachycardia	2/6950 (0%)	2	6/6950 (0.1%)	8
Congenital, familial and genetic disorders
Congenital cystic kidney disease	0/6950 (0%)	0	1/6950 (0%)	1
Hypertrophic cardiomyopathy	1/6950 (0%)	1	0/6950 (0%)	0
Pyloric stenosis	1/6950 (0%)	1	0/6950 (0%)	0
Renal dysplasia	1/6950 (0%)	1	0/6950 (0%)	0
Ear and labyrinth disorders
Sudden hearing loss	1/6950 (0%)	1	1/6950 (0%)	1
Vertigo	3/6950 (0%)	3	4/6950 (0.1%)	4
Vertigo positional	2/6950 (0%)	2	1/6950 (0%)	1
Vestibular disorder	0/6950 (0%)	0	3/6950 (0%)	3
Endocrine disorders
Autoimmune thyroiditis	0/6950 (0%)	0	1/6950 (0%)	1
Cushingoid	0/6950 (0%)	0	1/6950 (0%)	1
Goitre	1/6950 (0%)	1	1/6950 (0%)	1
Hyperparathyroidism primary	1/6950 (0%)	1	0/6950 (0%)	0
Hyperthyroidism	1/6950 (0%)	1	1/6950 (0%)	1
Hypothyroidism	0/6950 (0%)	0	3/6950 (0%)	3
Eye disorders
Age-related macular degeneration	0/6950 (0%)	0	1/6950 (0%)	1
Amaurosis fugax	1/6950 (0%)	1	1/6950 (0%)	1
Cataract	7/6950 (0.1%)	7	7/6950 (0.1%)	7
Choroidal effusion	0/6950 (0%)	0	1/6950 (0%)	1
Diplopia	1/6950 (0%)	1	0/6950 (0%)	0
Glaucoma	0/6950 (0%)	0	1/6950 (0%)	1
Iridocele	1/6950 (0%)	1	0/6950 (0%)	0
Iritis	0/6950 (0%)	0	1/6950 (0%)	1
Ocular hypertension	0/6950 (0%)	0	1/6950 (0%)	1
Ocular vascular disorder	1/6950 (0%)	1	0/6950 (0%)	0
Optic ischaemic neuropathy	2/6950 (0%)	2	0/6950 (0%)	0
Retinal degeneration	1/6950 (0%)	1	0/6950 (0%)	0
Retinal detachment	0/6950 (0%)	0	4/6950 (0.1%)	4
Retinal haemorrhage	0/6950 (0%)	0	1/6950 (0%)	1
Gastrointestinal disorders
Abdominal adhesions	0/6950 (0%)	0	1/6950 (0%)	1
Abdominal discomfort	1/6950 (0%)	1	1/6950 (0%)	1
Abdominal hernia	2/6950 (0%)	2	2/6950 (0%)	2
Abdominal pain	1/6950 (0%)	1	7/6950 (0.1%)	7
Abdominal pain upper	2/6950 (0%)	2	2/6950 (0%)	2
Abdominal strangulated hernia	0/6950 (0%)	0	1/6950 (0%)	1
Anal prolapse	0/6950 (0%)	0	1/6950 (0%)	1
Ascites	1/6950 (0%)	1	0/6950 (0%)	0
Autoimmune pancreatitis	1/6950 (0%)	1	0/6950 (0%)	0
Barrett's oesophagus	1/6950 (0%)	1	0/6950 (0%)	0
Chronic gastritis	0/6950 (0%)	0	2/6950 (0%)	2
Colitis	0/6950 (0%)	0	1/6950 (0%)	1
Colitis ischaemic	3/6950 (0%)	3	1/6950 (0%)	1
Colitis ulcerative	1/6950 (0%)	1	0/6950 (0%)	0
Constipation	3/6950 (0%)	3	2/6950 (0%)	2
Crohn's disease	1/6950 (0%)	1	1/6950 (0%)	1
Diaphragmatic hernia	0/6950 (0%)	0	1/6950 (0%)	1
Diaphragmatic hernia, obstructive	1/6950 (0%)	1	0/6950 (0%)	0
Diarrhoea	0/6950 (0%)	0	4/6950 (0.1%)	4
Diverticulum	3/6950 (0%)	3	3/6950 (0%)	3
Diverticulum intestinal	1/6950 (0%)	1	2/6950 (0%)	2
Diverticulum intestinal haemorrhagic	0/6950 (0%)	0	1/6950 (0%)	2
Duodenal ulcer	1/6950 (0%)	1	1/6950 (0%)	1
Duodenal ulcer haemorrhage	1/6950 (0%)	1	1/6950 (0%)	1
Duodenal ulcer perforation	1/6950 (0%)	1	1/6950 (0%)	1
Enteritis	1/6950 (0%)	1	0/6950 (0%)	0
Enterovesical fistula	1/6950 (0%)	1	0/6950 (0%)	0
Faecal incontinence	1/6950 (0%)	1	0/6950 (0%)	0
Gastric haemorrhage	0/6950 (0%)	0	1/6950 (0%)	1
Gastric perforation	1/6950 (0%)	1	0/6950 (0%)	0
Gastric ulcer	4/6950 (0.1%)	4	6/6950 (0.1%)	6
Gastric ulcer haemorrhage	2/6950 (0%)	2	4/6950 (0.1%)	4
Gastric ulcer perforation	1/6950 (0%)	1	0/6950 (0%)	0
Gastritis	3/6950 (0%)	3	6/6950 (0.1%)	6
Gastritis haemorrhagic	1/6950 (0%)	1	1/6950 (0%)	1
Gastrointestinal angiodysplasia	0/6950 (0%)	0	1/6950 (0%)	2
Gastrointestinal haemorrhage	3/6950 (0%)	3	4/6950 (0.1%)	5
Gastrooesophageal reflux disease	3/6950 (0%)	3	2/6950 (0%)	2
Haematochezia	0/6950 (0%)	0	2/6950 (0%)	2
Haemorrhoids	2/6950 (0%)	2	1/6950 (0%)	1
Hiatus hernia	1/6950 (0%)	1	1/6950 (0%)	1
Ileus	6/6950 (0.1%)	6	7/6950 (0.1%)	7
Incarcerated inguinal hernia	2/6950 (0%)	2	0/6950 (0%)	0
Incarcerated umbilical hernia	0/6950 (0%)	0	2/6950 (0%)	2
Inguinal hernia	5/6950 (0.1%)	5	10/6950 (0.1%)	10
Inguinal hernia strangulated	1/6950 (0%)	1	0/6950 (0%)	0
Intestinal haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Intestinal infarction	0/6950 (0%)	0	2/6950 (0%)	2
Intestinal ischaemia	2/6950 (0%)	2	2/6950 (0%)	2
Intestinal obstruction	6/6950 (0.1%)	6	6/6950 (0.1%)	6
Intestinal perforation	1/6950 (0%)	1	2/6950 (0%)	2
Large intestinal obstruction	2/6950 (0%)	2	0/6950 (0%)	0
Large intestine perforation	3/6950 (0%)	3	2/6950 (0%)	2
Large intestine polyp	3/6950 (0%)	3	4/6950 (0.1%)	4
Mallory-weiss syndrome	1/6950 (0%)	1	1/6950 (0%)	1
Melaena	0/6950 (0%)	0	1/6950 (0%)	1
Mesenteric artery embolism	0/6950 (0%)	0	1/6950 (0%)	1
Mesenteric artery thrombosis	1/6950 (0%)	1	0/6950 (0%)	0
Mesenteritis	1/6950 (0%)	1	0/6950 (0%)	0
Mouth ulceration	0/6950 (0%)	0	1/6950 (0%)	1
Nausea	2/6950 (0%)	2	0/6950 (0%)	0
Oesophageal haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Oesophageal spasm	2/6950 (0%)	2	0/6950 (0%)	0
Oesophageal ulcer	1/6950 (0%)	1	0/6950 (0%)	0
Oesophageal ulcer haemorrhage	0/6950 (0%)	0	1/6950 (0%)	1
Oesophagitis	1/6950 (0%)	1	0/6950 (0%)	0
Pancreatic disorder	0/6950 (0%)	0	1/6950 (0%)	1
Pancreatitis	3/6950 (0%)	3	8/6950 (0.1%)	8
Pancreatitis acute	5/6950 (0.1%)	5	4/6950 (0.1%)	5
Peptic ulcer haemorrhage	0/6950 (0%)	0	1/6950 (0%)	1
Pharyngo-oesophageal diverticulum	1/6950 (0%)	1	0/6950 (0%)	0
Proctitis	0/6950 (0%)	0	1/6950 (0%)	1
Rectal haemorrhage	2/6950 (0%)	2	3/6950 (0%)	3
Rectal perforation	0/6950 (0%)	0	1/6950 (0%)	1
Rectal polyp	1/6950 (0%)	1	0/6950 (0%)	0
Rectal prolapse	1/6950 (0%)	1	0/6950 (0%)	0
Retroperitoneal haemorrhage	0/6950 (0%)	0	2/6950 (0%)	2
Salivary gland calculus	1/6950 (0%)	1	0/6950 (0%)	0
Small intestinal obstruction	2/6950 (0%)	2	4/6950 (0.1%)	4
Subileus	1/6950 (0%)	1	0/6950 (0%)	0
Thrombosis mesenteric vessel	1/6950 (0%)	1	0/6950 (0%)	0
Umbilical hernia	2/6950 (0%)	2	2/6950 (0%)	2
Upper gastrointestinal haemorrhage	2/6950 (0%)	2	2/6950 (0%)	2
Vomiting	0/6950 (0%)	0	1/6950 (0%)	1
General disorders
Accidental death	1/6950 (0%)	1	0/6950 (0%)	0
Administration site erythema	1/6950 (0%)	1	0/6950 (0%)	0
Administration site pain	1/6950 (0%)	1	0/6950 (0%)	0
Adverse drug reaction	1/6950 (0%)	1	1/6950 (0%)	1
Asthenia	2/6950 (0%)	2	0/6950 (0%)	0
Cardiac death	0/6950 (0%)	0	1/6950 (0%)	1
Chest discomfort	0/6950 (0%)	0	3/6950 (0%)	4
Chest pain	20/6950 (0.3%)	20	19/6950 (0.3%)	20
Chills	1/6950 (0%)	1	0/6950 (0%)	0
Cyst	1/6950 (0%)	1	0/6950 (0%)	0
Death	17/6950 (0.2%)	17	29/6950 (0.4%)	29
Device battery issue	0/6950 (0%)	0	1/6950 (0%)	1
Device deposit issue	0/6950 (0%)	0	1/6950 (0%)	1
Device dislocation	1/6950 (0%)	1	2/6950 (0%)	2
Device leakage	1/6950 (0%)	1	0/6950 (0%)	0
Device occlusion	0/6950 (0%)	0	1/6950 (0%)	1
Drowning	0/6950 (0%)	0	1/6950 (0%)	1
Fatigue	1/6950 (0%)	1	0/6950 (0%)	0
General physical health deterioration	1/6950 (0%)	1	2/6950 (0%)	2
Generalised oedema	0/6950 (0%)	0	1/6950 (0%)	1
Ill-defined disorder	1/6950 (0%)	1	0/6950 (0%)	0
Incarcerated hernia	1/6950 (0%)	1	1/6950 (0%)	1
Inflammation	1/6950 (0%)	1	0/6950 (0%)	0
Malaise	1/6950 (0%)	1	0/6950 (0%)	0
Multi-organ failure	9/6950 (0.1%)	9	12/6950 (0.2%)	12
Non-cardiac chest pain	0/6950 (0%)	0	4/6950 (0.1%)	4
Oedema peripheral	1/6950 (0%)	1	1/6950 (0%)	1
Organ failure	2/6950 (0%)	2	1/6950 (0%)	1
Peripheral swelling	1/6950 (0%)	1	2/6950 (0%)	2
Pyrexia	2/6950 (0%)	2	1/6950 (0%)	1
Sudden cardiac death	2/6950 (0%)	2	3/6950 (0%)	3
Sudden death	13/6950 (0.2%)	13	4/6950 (0.1%)	4
Systemic inflammatory response syndrome	1/6950 (0%)	1	1/6950 (0%)	1
Thrombosis in device	1/6950 (0%)	1	0/6950 (0%)	0
Hepatobiliary disorders
Acute hepatic failure	0/6950 (0%)	0	1/6950 (0%)	1
Bile duct obstruction	1/6950 (0%)	1	0/6950 (0%)	0
Bile duct stone	3/6950 (0%)	3	3/6950 (0%)	3
Biliary colic	1/6950 (0%)	1	1/6950 (0%)	1
Biliary dilatation	0/6950 (0%)	0	1/6950 (0%)	1
Cholangitis	5/6950 (0.1%)	5	5/6950 (0.1%)	5
Cholangitis acute	0/6950 (0%)	0	2/6950 (0%)	2
Cholecystitis	7/6950 (0.1%)	8	15/6950 (0.2%)	17
Cholecystitis acute	7/6950 (0.1%)	7	4/6950 (0.1%)	4
Cholecystitis chronic	0/6950 (0%)	0	1/6950 (0%)	1
Cholelithiasis	14/6950 (0.2%)	14	14/6950 (0.2%)	14
Cholestasis	1/6950 (0%)	1	0/6950 (0%)	0
Chronic hepatic failure	0/6950 (0%)	0	1/6950 (0%)	1
Cirrhosis alcoholic	2/6950 (0%)	2	0/6950 (0%)	0
Drug-induced liver injury	0/6950 (0%)	0	1/6950 (0%)	1
Gallbladder perforation	0/6950 (0%)	0	1/6950 (0%)	1
Hepatic cirrhosis	2/6950 (0%)	2	3/6950 (0%)	3
Hepatic failure	2/6950 (0%)	2	1/6950 (0%)	1
Hepatic function abnormal	1/6950 (0%)	1	0/6950 (0%)	0
Hepatitis acute	0/6950 (0%)	0	1/6950 (0%)	1
Hepatitis alcoholic	1/6950 (0%)	1	0/6950 (0%)	0
Hyperbilirubinaemia	1/6950 (0%)	1	0/6950 (0%)	0
Ischaemic hepatitis	0/6950 (0%)	0	1/6950 (0%)	1
Jaundice cholestatic	2/6950 (0%)	2	0/6950 (0%)	0
Immune system disorders
Allergic granulomatous angiitis	1/6950 (0%)	1	0/6950 (0%)	0
Amyloidosis	1/6950 (0%)	1	1/6950 (0%)	1
Anaphylactic reaction	1/6950 (0%)	1	1/6950 (0%)	1
Drug hypersensitivity	0/6950 (0%)	0	2/6950 (0%)	2
Infections and infestations
Abdominal abscess	1/6950 (0%)	1	1/6950 (0%)	1
Abdominal infection	1/6950 (0%)	1	0/6950 (0%)	0
Acarodermatitis	0/6950 (0%)	0	1/6950 (0%)	1
Alcaligenes infection	1/6950 (0%)	1	0/6950 (0%)	0
Anal abscess	1/6950 (0%)	1	0/6950 (0%)	0
Anal fistula infection	0/6950 (0%)	0	1/6950 (0%)	1
Anorectal cellulitis	0/6950 (0%)	0	1/6950 (0%)	1
Appendiceal abscess	0/6950 (0%)	0	1/6950 (0%)	1
Appendicitis	5/6950 (0.1%)	5	5/6950 (0.1%)	5
Appendicitis perforated	0/6950 (0%)	0	1/6950 (0%)	1
Arteriosclerotic gangrene	0/6950 (0%)	0	1/6950 (0%)	1
Arthritis bacterial	1/6950 (0%)	1	1/6950 (0%)	1
Arthritis infective	0/6950 (0%)	0	2/6950 (0%)	2
Atypical pneumonia	1/6950 (0%)	1	0/6950 (0%)	0
Bacteraemia	1/6950 (0%)	1	0/6950 (0%)	0
Bacterial sepsis	2/6950 (0%)	2	2/6950 (0%)	2
Biliary tract infection	1/6950 (0%)	1	0/6950 (0%)	0
Bronchitis	8/6950 (0.1%)	8	7/6950 (0.1%)	8
Bronchitis bacterial	0/6950 (0%)	0	1/6950 (0%)	1
Bronchopneumonia	1/6950 (0%)	1	4/6950 (0.1%)	4
Candida infection	0/6950 (0%)	0	1/6950 (0%)	1
Candida sepsis	0/6950 (0%)	0	1/6950 (0%)	1
Cavernous sinus thrombosis	0/6950 (0%)	0	1/6950 (0%)	1
Cellulitis	8/6950 (0.1%)	8	14/6950 (0.2%)	14
Cholecystitis infective	1/6950 (0%)	1	1/6950 (0%)	1
Clostridium bacteraemia	0/6950 (0%)	0	1/6950 (0%)	1
Clostridium difficile colitis	1/6950 (0%)	1	5/6950 (0.1%)	5
Clostridium difficile infection	1/6950 (0%)	1	1/6950 (0%)	1
Colonic abscess	1/6950 (0%)	1	0/6950 (0%)	0
Cystitis	4/6950 (0.1%)	4	0/6950 (0%)	0
Cystitis klebsiella	1/6950 (0%)	1	0/6950 (0%)	0
Device related infection	1/6950 (0%)	1	1/6950 (0%)	1
Diabetic foot infection	0/6950 (0%)	0	1/6950 (0%)	1
Diverticulitis	5/6950 (0.1%)	5	11/6950 (0.2%)	11
Empyema	1/6950 (0%)	1	2/6950 (0%)	2
Encephalitis	1/6950 (0%)	1	1/6950 (0%)	1
Encephalitis viral	1/6950 (0%)	1	1/6950 (0%)	1
Endocarditis	3/6950 (0%)	3	0/6950 (0%)	0
Enterocolitis viral	1/6950 (0%)	1	0/6950 (0%)	0
Epididymitis	1/6950 (0%)	1	0/6950 (0%)	0
Erysipelas	3/6950 (0%)	4	7/6950 (0.1%)	7
Escherichia infection	1/6950 (0%)	1	0/6950 (0%)	0
Escherichia sepsis	1/6950 (0%)	1	2/6950 (0%)	2
Escherichia urinary tract infection	0/6950 (0%)	0	1/6950 (0%)	1
Gangrene	1/6950 (0%)	1	0/6950 (0%)	0
Gastroenteritis	8/6950 (0.1%)	8	8/6950 (0.1%)	8
Gastroenteritis clostridial	0/6950 (0%)	0	2/6950 (0%)	2
Gastroenteritis norovirus	1/6950 (0%)	1	1/6950 (0%)	1
Gastroenteritis salmonella	1/6950 (0%)	1	0/6950 (0%)	0
Gastroenteritis viral	2/6950 (0%)	2	2/6950 (0%)	2
Graft infection	1/6950 (0%)	1	0/6950 (0%)	0
Haematoma infection	0/6950 (0%)	0	1/6950 (0%)	1
Helicobacter infection	0/6950 (0%)	0	1/6950 (0%)	1
Herpes simplex	0/6950 (0%)	0	1/6950 (0%)	1
Herpes zoster	1/6950 (0%)	1	3/6950 (0%)	3
Herpes zoster disseminated	0/6950 (0%)	0	1/6950 (0%)	1
Herpes zoster meningitis	0/6950 (0%)	0	1/6950 (0%)	1
Herpes zoster oticus	1/6950 (0%)	1	0/6950 (0%)	0
Incision site infection	0/6950 (0%)	0	1/6950 (0%)	1
Infected dermal cyst	1/6950 (0%)	1	0/6950 (0%)	0
Infection	1/6950 (0%)	1	1/6950 (0%)	1
Infectious colitis	1/6950 (0%)	1	1/6950 (0%)	1
Infective exacerbation of chronic obstructive airways disease	2/6950 (0%)	2	1/6950 (0%)	1
Influenza	2/6950 (0%)	2	1/6950 (0%)	1
Intestinal gangrene	2/6950 (0%)	2	0/6950 (0%)	0
Kidney infection	1/6950 (0%)	1	0/6950 (0%)	0
Klebsiella bacteraemia	0/6950 (0%)	0	1/6950 (0%)	1
Klebsiella sepsis	0/6950 (0%)	0	1/6950 (0%)	1
Labyrinthitis	1/6950 (0%)	1	1/6950 (0%)	1
Liver abscess	2/6950 (0%)	2	1/6950 (0%)	1
Lobar pneumonia	4/6950 (0.1%)	4	8/6950 (0.1%)	8
Localised infection	1/6950 (0%)	1	0/6950 (0%)	0
Lower respiratory tract infection	1/6950 (0%)	1	1/6950 (0%)	1
Lung abscess	0/6950 (0%)	0	1/6950 (0%)	1
Lung infection	1/6950 (0%)	1	2/6950 (0%)	2
Medical device site infection	0/6950 (0%)	0	1/6950 (0%)	1
Meningitis	0/6950 (0%)	0	1/6950 (0%)	1
Nasopharyngitis	0/6950 (0%)	0	1/6950 (0%)	1
Necrotising fasciitis	1/6950 (0%)	1	1/6950 (0%)	1
Necrotising fasciitis streptococcal	0/6950 (0%)	0	1/6950 (0%)	1
Neuroborreliosis	1/6950 (0%)	1	0/6950 (0%)	0
Neutropenic sepsis	1/6950 (0%)	1	0/6950 (0%)	0
Oesophageal candidiasis	0/6950 (0%)	0	2/6950 (0%)	2
Ophthalmic herpes zoster	0/6950 (0%)	0	1/6950 (0%)	1
Orchitis	0/6950 (0%)	0	3/6950 (0%)	3
Oropharyngeal candidiasis	0/6950 (0%)	0	1/6950 (0%)	1
Osteomyelitis	1/6950 (0%)	1	1/6950 (0%)	1
Ovarian abscess	0/6950 (0%)	0	1/6950 (0%)	1
Pancreatic abscess	1/6950 (0%)	1	0/6950 (0%)	0
Peritonitis	4/6950 (0.1%)	4	4/6950 (0.1%)	4
Peritonitis bacterial	0/6950 (0%)	0	1/6950 (0%)	1
Pharyngitis	0/6950 (0%)	0	1/6950 (0%)	1
Pneumonia	70/6950 (1%)	73	81/6950 (1.2%)	86
Pneumonia bacterial	3/6950 (0%)	4	0/6950 (0%)	0
Pneumonia influenzal	2/6950 (0%)	2	0/6950 (0%)	0
Pneumonia klebsiella	1/6950 (0%)	1	2/6950 (0%)	2
Pneumonia pneumococcal	1/6950 (0%)	1	0/6950 (0%)	0
Pneumonia streptococcal	1/6950 (0%)	1	0/6950 (0%)	0
Pneumonia viral	0/6950 (0%)	0	1/6950 (0%)	1
Post procedural infection	0/6950 (0%)	0	3/6950 (0%)	3
Postoperative abscess	3/6950 (0%)	3	0/6950 (0%)	0
Postoperative wound infection	0/6950 (0%)	0	2/6950 (0%)	2
Pseudomembranous colitis	0/6950 (0%)	0	1/6950 (0%)	1
Pseudomonas infection	1/6950 (0%)	1	0/6950 (0%)	0
Psittacosis	1/6950 (0%)	1	0/6950 (0%)	0
Psoas abscess	0/6950 (0%)	0	1/6950 (0%)	1
Pulmonary tuberculosis	1/6950 (0%)	1	1/6950 (0%)	1
Purulence	1/6950 (0%)	1	0/6950 (0%)	0
Pyelonephritis	3/6950 (0%)	3	4/6950 (0.1%)	4
Pyelonephritis acute	4/6950 (0.1%)	4	0/6950 (0%)	0
Rectal abscess	1/6950 (0%)	1	0/6950 (0%)	0
Renal abscess	1/6950 (0%)	1	0/6950 (0%)	0
Respiratory moniliasis	0/6950 (0%)	0	1/6950 (0%)	1
Respiratory tract infection	1/6950 (0%)	1	3/6950 (0%)	3
Sepsis	26/6950 (0.4%)	27	17/6950 (0.2%)	17
Septic shock	11/6950 (0.2%)	11	14/6950 (0.2%)	14
Sinusitis	2/6950 (0%)	2	0/6950 (0%)	0
Soft tissue infection	1/6950 (0%)	1	0/6950 (0%)	0
Staphylococcal infection	4/6950 (0.1%)	4	1/6950 (0%)	1
Staphylococcal osteomyelitis	0/6950 (0%)	0	1/6950 (0%)	1
Staphylococcal sepsis	1/6950 (0%)	1	1/6950 (0%)	1
Streptococcal sepsis	0/6950 (0%)	0	1/6950 (0%)	1
Tonsillitis	0/6950 (0%)	0	1/6950 (0%)	1
Tooth abscess	1/6950 (0%)	1	0/6950 (0%)	0
Tuberculosis	2/6950 (0%)	3	0/6950 (0%)	0
Upper respiratory tract infection	0/6950 (0%)	0	3/6950 (0%)	3
Urinary tract infection	28/6950 (0.4%)	32	24/6950 (0.3%)	27
Urinary tract infection bacterial	2/6950 (0%)	2	0/6950 (0%)	0
Urosepsis	7/6950 (0.1%)	8	9/6950 (0.1%)	9
Vestibular neuronitis	0/6950 (0%)	0	3/6950 (0%)	3
Viral infection	2/6950 (0%)	2	2/6950 (0%)	2
Vulvitis	1/6950 (0%)	1	0/6950 (0%)	0
Wound infection	3/6950 (0%)	3	2/6950 (0%)	2
Injury, poisoning and procedural complications
Accident	1/6950 (0%)	1	0/6950 (0%)	0
Accidental overdose	1/6950 (0%)	1	0/6950 (0%)	0
Ankle fracture	3/6950 (0%)	3	5/6950 (0.1%)	5
Back injury	2/6950 (0%)	2	0/6950 (0%)	0
Bone fissure	0/6950 (0%)	0	1/6950 (0%)	1
Carbon monoxide poisoning	1/6950 (0%)	1	1/6950 (0%)	1
Cervical vertebral fracture	0/6950 (0%)	0	2/6950 (0%)	2
Chest injury	1/6950 (0%)	1	0/6950 (0%)	0
Clavicle fracture	0/6950 (0%)	0	1/6950 (0%)	1
Compression fracture	1/6950 (0%)	1	0/6950 (0%)	0
Concussion	4/6950 (0.1%)	4	3/6950 (0%)	3
Contusion	4/6950 (0.1%)	4	5/6950 (0.1%)	5
Coronary artery reocclusion	1/6950 (0%)	1	0/6950 (0%)	0
Coronary artery restenosis	0/6950 (0%)	0	1/6950 (0%)	1
Craniocerebral injury	0/6950 (0%)	0	2/6950 (0%)	2
Deep vein thrombosis postoperative	1/6950 (0%)	1	0/6950 (0%)	0
Eye penetration	1/6950 (0%)	1	0/6950 (0%)	0
Face injury	1/6950 (0%)	1	0/6950 (0%)	0
Facial bones fracture	2/6950 (0%)	2	4/6950 (0.1%)	4
Fall	8/6950 (0.1%)	8	5/6950 (0.1%)	5
Femoral neck fracture	2/6950 (0%)	2	6/6950 (0.1%)	6
Femur fracture	10/6950 (0.1%)	10	15/6950 (0.2%)	15
Fibula fracture	0/6950 (0%)	0	1/6950 (0%)	1
Foot fracture	2/6950 (0%)	2	2/6950 (0%)	2
Forearm fracture	1/6950 (0%)	1	0/6950 (0%)	0
Foreign body	0/6950 (0%)	0	1/6950 (0%)	1
Fractured sacrum	0/6950 (0%)	0	1/6950 (0%)	1
Gun shot wound	0/6950 (0%)	0	1/6950 (0%)	1
Hand fracture	2/6950 (0%)	2	1/6950 (0%)	1
Head injury	5/6950 (0.1%)	5	4/6950 (0.1%)	4
Hip fracture	7/6950 (0.1%)	7	2/6950 (0%)	2
Humerus fracture	3/6950 (0%)	3	6/6950 (0.1%)	6
Incisional hernia	0/6950 (0%)	0	1/6950 (0%)	1
Injury	0/6950 (0%)	0	1/6950 (0%)	1
Jaw fracture	0/6950 (0%)	0	1/6950 (0%)	1
Joint dislocation	3/6950 (0%)	3	0/6950 (0%)	0
Joint injury	2/6950 (0%)	2	2/6950 (0%)	2
Kidney contusion	1/6950 (0%)	1	0/6950 (0%)	0
Laceration	1/6950 (0%)	1	2/6950 (0%)	3
Ligament sprain	2/6950 (0%)	2	0/6950 (0%)	0
Limb crushing injury	1/6950 (0%)	1	0/6950 (0%)	0
Limb injury	0/6950 (0%)	0	1/6950 (0%)	1
Lower limb fracture	1/6950 (0%)	1	0/6950 (0%)	0
Lumbar vertebral fracture	2/6950 (0%)	2	2/6950 (0%)	2
Meniscus injury	3/6950 (0%)	3	2/6950 (0%)	2
Multiple fractures	1/6950 (0%)	1	0/6950 (0%)	0
Multiple injuries	1/6950 (0%)	1	2/6950 (0%)	2
Muscle rupture	0/6950 (0%)	0	2/6950 (0%)	2
Overdose	2/6950 (0%)	2	0/6950 (0%)	0
Patella fracture	3/6950 (0%)	3	1/6950 (0%)	1
Pelvic fracture	2/6950 (0%)	2	4/6950 (0.1%)	4
Pneumothorax traumatic	1/6950 (0%)	1	0/6950 (0%)	0
Post procedural complication	1/6950 (0%)	1	2/6950 (0%)	2
Post procedural haemorrhage	0/6950 (0%)	0	3/6950 (0%)	3
Post procedural pulmonary embolism	1/6950 (0%)	1	0/6950 (0%)	0
Postoperative wound complication	1/6950 (0%)	1	0/6950 (0%)	0
Procedural intestinal perforation	1/6950 (0%)	1	0/6950 (0%)	0
Procedural pain	1/6950 (0%)	1	0/6950 (0%)	0
Pubis fracture	2/6950 (0%)	2	3/6950 (0%)	3
Radius fracture	5/6950 (0.1%)	5	5/6950 (0.1%)	5
Respiratory fume inhalation disorder	0/6950 (0%)	0	1/6950 (0%)	1
Rib fracture	6/6950 (0.1%)	6	7/6950 (0.1%)	7
Road traffic accident	1/6950 (0%)	1	1/6950 (0%)	1
Skin wound	1/6950 (0%)	1	0/6950 (0%)	0
Skull fracture	3/6950 (0%)	3	0/6950 (0%)	0
Spinal compression fracture	6/6950 (0.1%)	6	1/6950 (0%)	1
Spinal cord injury	0/6950 (0%)	0	1/6950 (0%)	1
Spinal cord injury cervical	1/6950 (0%)	1	0/6950 (0%)	0
Spinal fracture	1/6950 (0%)	1	1/6950 (0%)	1
Splenic rupture	0/6950 (0%)	0	1/6950 (0%)	1
Subdural haematoma	9/6950 (0.1%)	10	6/6950 (0.1%)	6
Subdural haemorrhage	0/6950 (0%)	0	1/6950 (0%)	1
Synovial rupture	0/6950 (0%)	0	1/6950 (0%)	1
Tendon rupture	4/6950 (0.1%)	4	4/6950 (0.1%)	4
Thermal burn	0/6950 (0%)	0	1/6950 (0%)	1
Thoracic vertebral fracture	0/6950 (0%)	0	1/6950 (0%)	1
Tibia fracture	2/6950 (0%)	2	3/6950 (0%)	3
Toxicity to various agents	4/6950 (0.1%)	4	2/6950 (0%)	2
Traumatic fracture	0/6950 (0%)	0	1/6950 (0%)	1
Traumatic intracranial haemorrhage	1/6950 (0%)	1	1/6950 (0%)	1
Ulna fracture	0/6950 (0%)	0	1/6950 (0%)	1
Upper limb fracture	4/6950 (0.1%)	4	4/6950 (0.1%)	4
Vascular graft occlusion	1/6950 (0%)	1	1/6950 (0%)	1
Vascular pseudoaneurysm	1/6950 (0%)	1	0/6950 (0%)	0
Wound	1/6950 (0%)	1	0/6950 (0%)	0
Wound dehiscence	0/6950 (0%)	0	1/6950 (0%)	1
Wound evisceration	0/6950 (0%)	0	1/6950 (0%)	1
Wound haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Wrist fracture	0/6950 (0%)	0	2/6950 (0%)	2
Investigations
Blood creatine phosphokinase increased	0/6950 (0%)	0	1/6950 (0%)	1
Blood glucose fluctuation	1/6950 (0%)	1	0/6950 (0%)	0
Blood pressure increased	0/6950 (0%)	0	1/6950 (0%)	1
C-reactive protein increased	0/6950 (0%)	0	1/6950 (0%)	1
Haemoglobin decreased	0/6950 (0%)	0	1/6950 (0%)	1
Heart rate decreased	1/6950 (0%)	1	0/6950 (0%)	0
Liver function test abnormal	0/6950 (0%)	0	1/6950 (0%)	1
Weight increased	1/6950 (0%)	1	0/6950 (0%)	0
Metabolism and nutrition disorders
Cachexia	2/6950 (0%)	2	2/6950 (0%)	2
Decreased appetite	0/6950 (0%)	0	2/6950 (0%)	2
Dehydration	8/6950 (0.1%)	8	8/6950 (0.1%)	8
Diabetes mellitus	2/6950 (0%)	2	3/6950 (0%)	3
Diabetes mellitus inadequate control	0/6950 (0%)	0	2/6950 (0%)	2
Diabetic ketoacidosis	1/6950 (0%)	1	1/6950 (0%)	1
Electrolyte imbalance	1/6950 (0%)	1	1/6950 (0%)	1
Failure to thrive	0/6950 (0%)	0	2/6950 (0%)	2
Gout	2/6950 (0%)	2	0/6950 (0%)	0
Hypercholesterolaemia	0/6950 (0%)	0	1/6950 (0%)	1
Hyperglycaemia	1/6950 (0%)	1	2/6950 (0%)	2
Hyperkalaemia	0/6950 (0%)	0	2/6950 (0%)	2
Hyperlipidaemia	1/6950 (0%)	1	1/6950 (0%)	1
Hypocalcaemia	0/6950 (0%)	0	1/6950 (0%)	1
Hypoglycaemia	6/6950 (0.1%)	6	4/6950 (0.1%)	4
Hypokalaemia	7/6950 (0.1%)	7	2/6950 (0%)	2
Hyponatraemia	2/6950 (0%)	2	5/6950 (0.1%)	5
Hypophagia	1/6950 (0%)	1	0/6950 (0%)	0
Hypovolaemia	0/6950 (0%)	0	1/6950 (0%)	1
Lactic acidosis	0/6950 (0%)	0	1/6950 (0%)	1
Malnutrition	1/6950 (0%)	1	2/6950 (0%)	2
Marasmus	0/6950 (0%)	0	1/6950 (0%)	1
Type 2 diabetes mellitus	5/6950 (0.1%)	5	6/6950 (0.1%)	6
Uraemic acidosis	0/6950 (0%)	0	1/6950 (0%)	1
Musculoskeletal and connective tissue disorders
Acquired claw toe	0/6950 (0%)	0	1/6950 (0%)	1
Arthralgia	0/6950 (0%)	0	1/6950 (0%)	1
Arthritis	1/6950 (0%)	1	1/6950 (0%)	1
Arthrofibrosis	0/6950 (0%)	0	1/6950 (0%)	1
Arthropathy	0/6950 (0%)	0	1/6950 (0%)	1
Back pain	2/6950 (0%)	2	5/6950 (0.1%)	5
Bursitis	2/6950 (0%)	2	0/6950 (0%)	0
Cervical spinal stenosis	0/6950 (0%)	0	1/6950 (0%)	1
Chondrocalcinosis	0/6950 (0%)	0	1/6950 (0%)	1
Chondropathy	0/6950 (0%)	0	1/6950 (0%)	1
Foot deformity	1/6950 (0%)	1	1/6950 (0%)	1
Gouty arthritis	2/6950 (0%)	2	1/6950 (0%)	1
Intervertebral disc disorder	1/6950 (0%)	1	0/6950 (0%)	0
Intervertebral disc protrusion	5/6950 (0.1%)	5	4/6950 (0.1%)	4
Joint effusion	0/6950 (0%)	0	1/6950 (0%)	1
Lumbar spinal stenosis	0/6950 (0%)	0	1/6950 (0%)	1
Meniscal degeneration	0/6950 (0%)	0	1/6950 (0%)	1
Mixed connective tissue disease	0/6950 (0%)	0	1/6950 (0%)	1
Muscular weakness	0/6950 (0%)	0	1/6950 (0%)	1
Musculoskeletal pain	2/6950 (0%)	2	1/6950 (0%)	1
Myositis	1/6950 (0%)	1	0/6950 (0%)	0
Osteoarthritis	26/6950 (0.4%)	26	17/6950 (0.2%)	17
Osteochondritis	1/6950 (0%)	1	0/6950 (0%)	0
Osteoporosis	0/6950 (0%)	0	2/6950 (0%)	2
Osteoporotic fracture	1/6950 (0%)	1	0/6950 (0%)	0
Pain in extremity	0/6950 (0%)	0	1/6950 (0%)	1
Pathological fracture	1/6950 (0%)	1	1/6950 (0%)	1
Polymyalgia rheumatica	5/6950 (0.1%)	5	4/6950 (0.1%)	4
Polymyositis	0/6950 (0%)	0	1/6950 (0%)	1
Pseudarthrosis	0/6950 (0%)	0	1/6950 (0%)	1
Rhabdomyolysis	0/6950 (0%)	0	2/6950 (0%)	2
Rheumatoid arthritis	2/6950 (0%)	2	1/6950 (0%)	1
Rotator cuff syndrome	3/6950 (0%)	3	2/6950 (0%)	2
Sjogren's syndrome	1/6950 (0%)	1	0/6950 (0%)	0
Spinal column stenosis	6/6950 (0.1%)	6	6/6950 (0.1%)	6
Spinal osteoarthritis	3/6950 (0%)	3	5/6950 (0.1%)	5
Spinal pain	0/6950 (0%)	0	1/6950 (0%)	1
Spondyloarthropathy	2/6950 (0%)	2	0/6950 (0%)	0
Spondylolisthesis	1/6950 (0%)	1	0/6950 (0%)	0
Still's disease adult onset	1/6950 (0%)	1	0/6950 (0%)	0
Synovial cyst	0/6950 (0%)	0	1/6950 (0%)	1
Synovitis	0/6950 (0%)	0	1/6950 (0%)	1
Systemic lupus erythematosus	0/6950 (0%)	0	2/6950 (0%)	2
Tenosynovitis	1/6950 (0%)	1	0/6950 (0%)	0
Trigger finger	0/6950 (0%)	0	2/6950 (0%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma	0/6950 (0%)	0	1/6950 (0%)	1
Acute monocytic leukaemia	0/6950 (0%)	0	1/6950 (0%)	1
Acute myeloid leukaemia	2/6950 (0%)	2	0/6950 (0%)	0
Adenocarcinoma	1/6950 (0%)	1	3/6950 (0%)	3
Adenocarcinoma gastric	3/6950 (0%)	3	1/6950 (0%)	1
Adenocarcinoma of colon	4/6950 (0.1%)	4	4/6950 (0.1%)	4
Adenocarcinoma pancreas	1/6950 (0%)	1	1/6950 (0%)	1
Adrenal adenoma	1/6950 (0%)	1	0/6950 (0%)	0
Adrenal gland cancer	0/6950 (0%)	0	1/6950 (0%)	1
Anaplastic astrocytoma	0/6950 (0%)	0	1/6950 (0%)	1
Anaplastic thyroid cancer	1/6950 (0%)	1	0/6950 (0%)	0
B precursor type acute leukaemia	1/6950 (0%)	1	0/6950 (0%)	0
B-cell lymphoma	1/6950 (0%)	1	2/6950 (0%)	2
Basal cell carcinoma	5/6950 (0.1%)	5	3/6950 (0%)	3
Benign neoplasm of thyroid gland	0/6950 (0%)	0	1/6950 (0%)	1
Benign ovarian tumour	1/6950 (0%)	1	0/6950 (0%)	0
Bile duct cancer	2/6950 (0%)	2	0/6950 (0%)	0
Bladder cancer	6/6950 (0.1%)	6	13/6950 (0.2%)	13
Bladder cancer recurrent	2/6950 (0%)	2	1/6950 (0%)	1
Bladder neoplasm	3/6950 (0%)	3	4/6950 (0.1%)	4
Bladder papilloma	1/6950 (0%)	1	1/6950 (0%)	1
Bladder transitional cell carcinoma	1/6950 (0%)	1	2/6950 (0%)	2
Bladder transitional cell carcinoma recurrent	1/6950 (0%)	1	0/6950 (0%)	0
Bone cancer	1/6950 (0%)	1	0/6950 (0%)	0
Bowen's disease	0/6950 (0%)	0	2/6950 (0%)	2
Brain neoplasm benign	1/6950 (0%)	1	0/6950 (0%)	0
Breast cancer	5/6950 (0.1%)	5	4/6950 (0.1%)	4
Breast cancer metastatic	0/6950 (0%)	0	2/6950 (0%)	2
Bronchial carcinoma	1/6950 (0%)	1	0/6950 (0%)	0
Carcinoid tumour pulmonary	0/6950 (0%)	0	1/6950 (0%)	1
Central nervous system neoplasm	0/6950 (0%)	0	1/6950 (0%)	1
Cholangiocarcinoma	2/6950 (0%)	2	3/6950 (0%)	3
Cholesteatoma	1/6950 (0%)	1	0/6950 (0%)	0
Chronic lymphocytic leukaemia	0/6950 (0%)	0	1/6950 (0%)	1
Chronic myeloid leukaemia	1/6950 (0%)	1	0/6950 (0%)	0
Colon adenoma	0/6950 (0%)	0	1/6950 (0%)	1
Colon cancer	9/6950 (0.1%)	9	6/6950 (0.1%)	6
Colon cancer metastatic	3/6950 (0%)	3	3/6950 (0%)	3
Colon neoplasm	0/6950 (0%)	0	2/6950 (0%)	2
Diffuse large b-cell lymphoma	1/6950 (0%)	1	0/6950 (0%)	0
Diffuse large b-cell lymphoma stage iv	0/6950 (0%)	0	1/6950 (0%)	1
Endometrial adenocarcinoma	0/6950 (0%)	0	2/6950 (0%)	2
Fallopian tube cancer	0/6950 (0%)	0	1/6950 (0%)	1
Follicular thyroid cancer	0/6950 (0%)	0	1/6950 (0%)	1
Gallbladder cancer	1/6950 (0%)	1	0/6950 (0%)	0
Gastric cancer	6/6950 (0.1%)	6	3/6950 (0%)	3
Gastrointestinal carcinoma	2/6950 (0%)	2	0/6950 (0%)	0
Gastrointestinal stromal tumour	1/6950 (0%)	1	0/6950 (0%)	0
Gastrointestinal tract adenoma	1/6950 (0%)	1	0/6950 (0%)	0
Glioblastoma	0/6950 (0%)	0	1/6950 (0%)	1
Glioblastoma multiforme	1/6950 (0%)	1	0/6950 (0%)	0
Hepatic cancer	2/6950 (0%)	2	6/6950 (0.1%)	6
Hepatic cancer metastatic	1/6950 (0%)	1	0/6950 (0%)	0
Hepatic neoplasm	0/6950 (0%)	0	2/6950 (0%)	2
Hepatocellular carcinoma	2/6950 (0%)	4	1/6950 (0%)	1
Hypergammaglobulinaemia benign monoclonal	0/6950 (0%)	0	1/6950 (0%)	1
Intestinal adenocarcinoma	1/6950 (0%)	1	0/6950 (0%)	0
Invasive ductal breast carcinoma	2/6950 (0%)	2	2/6950 (0%)	2
Invasive lobular breast carcinoma	0/6950 (0%)	0	2/6950 (0%)	2
Invasive papillary breast carcinoma	0/6950 (0%)	0	1/6950 (0%)	1
Large cell lung cancer	0/6950 (0%)	0	1/6950 (0%)	1
Large intestine benign neoplasm	1/6950 (0%)	1	0/6950 (0%)	0
Laryngeal cancer	1/6950 (0%)	1	0/6950 (0%)	0
Lung adenocarcinoma	1/6950 (0%)	1	6/6950 (0.1%)	6
Lung adenocarcinoma metastatic	1/6950 (0%)	1	2/6950 (0%)	2
Lung adenocarcinoma stage iii	0/6950 (0%)	0	1/6950 (0%)	1
Lung cancer metastatic	6/6950 (0.1%)	6	4/6950 (0.1%)	4
Lung neoplasm	1/6950 (0%)	1	3/6950 (0%)	3
Lung neoplasm malignant	22/6950 (0.3%)	23	13/6950 (0.2%)	13
Lymphoma	2/6950 (0%)	3	3/6950 (0%)	3
Malignant fibrous histiocytoma of bone	1/6950 (0%)	1	0/6950 (0%)	0
Malignant lymphoma unclassifiable high grade	0/6950 (0%)	0	1/6950 (0%)	1
Malignant mast cell neoplasm	0/6950 (0%)	0	1/6950 (0%)	1
Malignant melanoma	3/6950 (0%)	3	4/6950 (0.1%)	4
Malignant melanoma in situ	1/6950 (0%)	1	1/6950 (0%)	1
Malignant neoplasm of ampulla of vater	2/6950 (0%)	2	0/6950 (0%)	0
Malignant palate neoplasm	1/6950 (0%)	1	0/6950 (0%)	0
Meningioma	0/6950 (0%)	0	2/6950 (0%)	2
Mesothelioma	1/6950 (0%)	1	0/6950 (0%)	0
Metastases to adrenals	1/6950 (0%)	1	0/6950 (0%)	0
Metastases to bone	2/6950 (0%)	2	4/6950 (0.1%)	4
Metastases to central nervous system	4/6950 (0.1%)	4	2/6950 (0%)	2
Metastases to gastrointestinal tract	0/6950 (0%)	0	1/6950 (0%)	1
Metastases to liver	5/6950 (0.1%)	5	5/6950 (0.1%)	5
Metastases to lung	2/6950 (0%)	2	1/6950 (0%)	1
Metastases to lymph nodes	1/6950 (0%)	1	1/6950 (0%)	1
Metastases to peritoneum	3/6950 (0%)	3	0/6950 (0%)	0
Metastases to stomach	1/6950 (0%)	1	0/6950 (0%)	0
Metastasis	0/6950 (0%)	0	1/6950 (0%)	1
Metastatic carcinoma of the bladder	2/6950 (0%)	2	1/6950 (0%)	1
Metastatic gastric cancer	1/6950 (0%)	1	2/6950 (0%)	2
Metastatic malignant melanoma	2/6950 (0%)	2	2/6950 (0%)	2
Metastatic neoplasm	1/6950 (0%)	1	2/6950 (0%)	2
Metastatic renal cell carcinoma	1/6950 (0%)	1	1/6950 (0%)	1
Metastatic squamous cell carcinoma	0/6950 (0%)	0	2/6950 (0%)	2
Myelodysplastic syndrome	1/6950 (0%)	1	1/6950 (0%)	1
Neoplasm malignant	2/6950 (0%)	2	3/6950 (0%)	3
Neoplasm prostate	0/6950 (0%)	0	1/6950 (0%)	1
Non-hodgkin's lymphoma	0/6950 (0%)	0	3/6950 (0%)	3
Non-small cell lung cancer	1/6950 (0%)	1	1/6950 (0%)	1
Non-small cell lung cancer stage iv	0/6950 (0%)	0	2/6950 (0%)	2
Oesophageal adenocarcinoma	0/6950 (0%)	0	2/6950 (0%)	2
Oesophageal adenocarcinoma metastatic	1/6950 (0%)	1	0/6950 (0%)	0
Oesophageal cancer metastatic	2/6950 (0%)	2	1/6950 (0%)	1
Oesophageal carcinoma	6/6950 (0.1%)	6	1/6950 (0%)	1
Oesophageal squamous cell carcinoma	1/6950 (0%)	1	1/6950 (0%)	1
Ovarian cancer	4/6950 (0.1%)	4	0/6950 (0%)	0
Ovarian cancer recurrent	0/6950 (0%)	0	1/6950 (0%)	1
Ovarian epithelial cancer	0/6950 (0%)	0	1/6950 (0%)	1
Ovarian germ cell teratoma benign	1/6950 (0%)	1	0/6950 (0%)	0
Pancreatic carcinoma	7/6950 (0.1%)	7	10/6950 (0.1%)	10
Pancreatic carcinoma metastatic	3/6950 (0%)	3	2/6950 (0%)	2
Pancreatic neoplasm	3/6950 (0%)	3	0/6950 (0%)	0
Pancreatic neuroendocrine tumour	1/6950 (0%)	1	0/6950 (0%)	0
Papillary thyroid cancer	0/6950 (0%)	0	1/6950 (0%)	1
Paraganglion neoplasm	1/6950 (0%)	1	0/6950 (0%)	0
Parathyroid tumour benign	1/6950 (0%)	1	0/6950 (0%)	0
Pituitary tumour benign	1/6950 (0%)	1	1/6950 (0%)	1
Plasma cell myeloma	1/6950 (0%)	1	1/6950 (0%)	1
Prostate cancer	19/6950 (0.3%)	19	18/6950 (0.3%)	18
Prostate cancer metastatic	3/6950 (0%)	3	2/6950 (0%)	2
Prostate cancer recurrent	3/6950 (0%)	3	0/6950 (0%)	0
Prostate cancer stage iv	0/6950 (0%)	0	1/6950 (0%)	1
Prostatic adenoma	0/6950 (0%)	0	1/6950 (0%)	1
Rectal adenocarcinoma	4/6950 (0.1%)	4	1/6950 (0%)	1
Rectal adenoma	0/6950 (0%)	0	1/6950 (0%)	1
Rectal cancer	1/6950 (0%)	1	2/6950 (0%)	2
Rectal cancer recurrent	1/6950 (0%)	1	0/6950 (0%)	0
Renal cancer	1/6950 (0%)	1	2/6950 (0%)	2
Renal cancer metastatic	0/6950 (0%)	0	1/6950 (0%)	1
Renal cell carcinoma	3/6950 (0%)	3	4/6950 (0.1%)	4
Renal cell carcinoma recurrent	0/6950 (0%)	0	1/6950 (0%)	1
Renal oncocytoma	1/6950 (0%)	1	0/6950 (0%)	0
Salivary gland cancer	1/6950 (0%)	1	0/6950 (0%)	0
Sarcoma	0/6950 (0%)	0	1/6950 (0%)	1
Skin cancer	0/6950 (0%)	0	1/6950 (0%)	1
Small cell lung cancer	1/6950 (0%)	1	1/6950 (0%)	1
Small cell lung cancer metastatic	0/6950 (0%)	0	2/6950 (0%)	2
Small intestine adenocarcinoma	1/6950 (0%)	1	0/6950 (0%)	0
Squamous cell carcinoma	2/6950 (0%)	2	3/6950 (0%)	3
Squamous cell carcinoma of lung	2/6950 (0%)	2	0/6950 (0%)	0
Squamous cell carcinoma of skin	0/6950 (0%)	0	2/6950 (0%)	2
Squamous cell carcinoma of the oral cavity	1/6950 (0%)	1	0/6950 (0%)	0
Sweat gland tumour	1/6950 (0%)	1	0/6950 (0%)	0
T-cell lymphoma	0/6950 (0%)	0	1/6950 (0%)	1
Throat cancer	1/6950 (0%)	1	1/6950 (0%)	1
Thyroid cancer	2/6950 (0%)	2	0/6950 (0%)	0
Tongue neoplasm malignant stage unspecified	1/6950 (0%)	1	0/6950 (0%)	0
Transitional cell carcinoma	2/6950 (0%)	2	0/6950 (0%)	0
Transitional cell carcinoma metastatic	0/6950 (0%)	0	1/6950 (0%)	1
Urethral neoplasm	1/6950 (0%)	1	0/6950 (0%)	0
Vulval cancer	1/6950 (0%)	1	0/6950 (0%)	0
Nervous system disorders
Amnesia	1/6950 (0%)	1	0/6950 (0%)	0
Amyotrophic lateral sclerosis	2/6950 (0%)	2	0/6950 (0%)	0
Ataxia	0/6950 (0%)	0	1/6950 (0%)	1
Balance disorder	0/6950 (0%)	0	2/6950 (0%)	2
Basal ganglia haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Basilar artery thrombosis	0/6950 (0%)	0	1/6950 (0%)	1
Brain injury	0/6950 (0%)	0	1/6950 (0%)	1
Brain stem infarction	0/6950 (0%)	0	1/6950 (0%)	1
Brain stem syndrome	1/6950 (0%)	1	0/6950 (0%)	0
Carotid artery occlusion	1/6950 (0%)	1	0/6950 (0%)	0
Carotid artery stenosis	1/6950 (0%)	1	1/6950 (0%)	1
Carotid sinus syndrome	0/6950 (0%)	0	1/6950 (0%)	1
Carpal tunnel syndrome	1/6950 (0%)	1	0/6950 (0%)	0
Central nervous system lesion	0/6950 (0%)	0	1/6950 (0%)	1
Cerebellar haemorrhage	0/6950 (0%)	0	2/6950 (0%)	2
Cerebellar ischaemia	0/6950 (0%)	0	1/6950 (0%)	1
Cerebral artery embolism	1/6950 (0%)	1	1/6950 (0%)	1
Cerebral artery thrombosis	1/6950 (0%)	1	0/6950 (0%)	0
Cerebral atrophy	0/6950 (0%)	0	1/6950 (0%)	1
Cerebral haemorrhage	6/6950 (0.1%)	6	7/6950 (0.1%)	7
Cerebral infarction	16/6950 (0.2%)	16	17/6950 (0.2%)	17
Cerebral ischaemia	2/6950 (0%)	2	3/6950 (0%)	3
Cerebrospinal fluid leakage	0/6950 (0%)	0	1/6950 (0%)	1
Cerebrovascular accident	34/6950 (0.5%)	34	31/6950 (0.4%)	33
Cerebrovascular disorder	3/6950 (0%)	3	1/6950 (0%)	1
Cervical myelopathy	1/6950 (0%)	1	0/6950 (0%)	0
Cognitive disorder	1/6950 (0%)	1	1/6950 (0%)	1
Coma	0/6950 (0%)	0	1/6950 (0%)	1
Dementia	4/6950 (0.1%)	4	2/6950 (0%)	2
Dementia alzheimer's type	2/6950 (0%)	2	0/6950 (0%)	0
Dementia with lewy bodies	0/6950 (0%)	0	1/6950 (0%)	1
Diabetic coma	1/6950 (0%)	1	0/6950 (0%)	0
Dizziness	1/6950 (0%)	1	5/6950 (0.1%)	5
Drop attacks	0/6950 (0%)	0	1/6950 (0%)	1
Dural arteriovenous fistula	0/6950 (0%)	0	1/6950 (0%)	1
Dyspraxia	1/6950 (0%)	1	0/6950 (0%)	0
Epilepsy	2/6950 (0%)	2	4/6950 (0.1%)	4
Generalised tonic-clonic seizure	2/6950 (0%)	2	0/6950 (0%)	0
Guillain-barre syndrome	1/6950 (0%)	1	2/6950 (0%)	2
Haemorrhage intracranial	1/6950 (0%)	1	2/6950 (0%)	2
Haemorrhagic stroke	0/6950 (0%)	0	4/6950 (0.1%)	4
Headache	0/6950 (0%)	0	1/6950 (0%)	1
Hemiplegia	1/6950 (0%)	1	0/6950 (0%)	0
Hydrocephalus	1/6950 (0%)	1	1/6950 (0%)	1
Hypertonia	0/6950 (0%)	0	1/6950 (0%)	1
Hypoaesthesia	2/6950 (0%)	2	0/6950 (0%)	0
Hypoxic-ischaemic encephalopathy	0/6950 (0%)	0	1/6950 (0%)	1
Intracranial aneurysm	0/6950 (0%)	0	1/6950 (0%)	1
Intraventricular haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Ischaemic stroke	7/6950 (0.1%)	7	6/6950 (0.1%)	6
Lacunar infarction	2/6950 (0%)	2	2/6950 (0%)	2
Loss of consciousness	1/6950 (0%)	1	1/6950 (0%)	1
Lumbar radiculopathy	0/6950 (0%)	0	2/6950 (0%)	2
Memory impairment	0/6950 (0%)	0	1/6950 (0%)	1
Miller fisher syndrome	0/6950 (0%)	0	1/6950 (0%)	1
Mixed dementia	1/6950 (0%)	1	1/6950 (0%)	1
Myasthenia gravis	0/6950 (0%)	0	1/6950 (0%)	1
Myoclonus	1/6950 (0%)	1	0/6950 (0%)	0
Nerve compression	0/6950 (0%)	0	1/6950 (0%)	1
Neuralgia	0/6950 (0%)	0	1/6950 (0%)	1
Neuropathy peripheral	0/6950 (0%)	0	1/6950 (0%)	1
Paralysis	1/6950 (0%)	1	0/6950 (0%)	0
Parkinson's disease	1/6950 (0%)	1	0/6950 (0%)	0
Parkinsonism	0/6950 (0%)	0	2/6950 (0%)	2
Partial seizures	0/6950 (0%)	0	1/6950 (0%)	1
Polyneuropathy	0/6950 (0%)	0	1/6950 (0%)	1
Post herpetic neuralgia	0/6950 (0%)	0	1/6950 (0%)	1
Presyncope	1/6950 (0%)	1	2/6950 (0%)	2
Progressive supranuclear palsy	0/6950 (0%)	0	1/6950 (0%)	1
Radiculopathy	0/6950 (0%)	0	1/6950 (0%)	1
Restless legs syndrome	0/6950 (0%)	0	1/6950 (0%)	1
Sciatica	4/6950 (0.1%)	4	4/6950 (0.1%)	4
Seizure	2/6950 (0%)	2	0/6950 (0%)	0
Senile dementia	0/6950 (0%)	0	2/6950 (0%)	2
Somnolence	0/6950 (0%)	0	1/6950 (0%)	1
Spondylitic myelopathy	0/6950 (0%)	0	1/6950 (0%)	1
Status epilepticus	0/6950 (0%)	0	1/6950 (0%)	1
Subarachnoid haemorrhage	5/6950 (0.1%)	5	7/6950 (0.1%)	7
Syncope	11/6950 (0.2%)	11	20/6950 (0.3%)	22
Thalamic infarction	0/6950 (0%)	0	1/6950 (0%)	1
Thalamus haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Thrombotic cerebral infarction	0/6950 (0%)	0	2/6950 (0%)	2
Transient global amnesia	1/6950 (0%)	1	1/6950 (0%)	1
Transient ischaemic attack	20/6950 (0.3%)	22	14/6950 (0.2%)	15
Trigeminal neuralgia	1/6950 (0%)	1	0/6950 (0%)	0
Vascular dementia	0/6950 (0%)	0	1/6950 (0%)	1
Vertebrobasilar insufficiency	1/6950 (0%)	1	0/6950 (0%)	0
Viiith nerve lesion	1/6950 (0%)	1	0/6950 (0%)	0
Viith nerve paralysis	2/6950 (0%)	2	2/6950 (0%)	2
Psychiatric disorders
Abnormal behaviour	0/6950 (0%)	0	1/6950 (0%)	1
Acute psychosis	0/6950 (0%)	0	1/6950 (0%)	1
Affective disorder	1/6950 (0%)	1	0/6950 (0%)	0
Alcohol withdrawal syndrome	0/6950 (0%)	0	1/6950 (0%)	1
Anxiety disorder	1/6950 (0%)	1	0/6950 (0%)	0
Breathing-related sleep disorder	0/6950 (0%)	0	1/6950 (0%)	1
Completed suicide	1/6950 (0%)	1	1/6950 (0%)	1
Confusional state	2/6950 (0%)	2	0/6950 (0%)	0
Delirium	2/6950 (0%)	2	3/6950 (0%)	3
Depressed mood	2/6950 (0%)	2	0/6950 (0%)	0
Depression	4/6950 (0.1%)	4	3/6950 (0%)	3
Disorientation	1/6950 (0%)	1	0/6950 (0%)	0
Hallucination	0/6950 (0%)	0	2/6950 (0%)	2
Major depression	0/6950 (0%)	0	2/6950 (0%)	2
Mental disorder	1/6950 (0%)	1	0/6950 (0%)	0
Mental disorder due to a general medical condition	0/6950 (0%)	0	1/6950 (0%)	1
Mental status changes	0/6950 (0%)	0	2/6950 (0%)	2
Panic attack	0/6950 (0%)	0	1/6950 (0%)	1
Panic disorder	1/6950 (0%)	1	0/6950 (0%)	0
Psychotic disorder	1/6950 (0%)	1	0/6950 (0%)	0
Schizoaffective disorder bipolar type	0/6950 (0%)	0	1/6950 (0%)	1
Schizophrenia	0/6950 (0%)	0	1/6950 (0%)	1
Somatoform disorder	1/6950 (0%)	1	0/6950 (0%)	0
Suicidal ideation	0/6950 (0%)	0	1/6950 (0%)	1
Renal and urinary disorders
Acute kidney injury	18/6950 (0.3%)	19	19/6950 (0.3%)	20
Acute prerenal failure	1/6950 (0%)	1	1/6950 (0%)	1
Bladder neck obstruction	1/6950 (0%)	1	0/6950 (0%)	0
Bladder perforation	0/6950 (0%)	0	2/6950 (0%)	2
Bladder prolapse	0/6950 (0%)	0	2/6950 (0%)	2
Calculus ureteric	0/6950 (0%)	0	1/6950 (0%)	1
Chronic kidney disease	4/6950 (0.1%)	4	11/6950 (0.2%)	12
Cystitis haemorrhagic	1/6950 (0%)	1	0/6950 (0%)	0
Cystitis interstitial	0/6950 (0%)	0	1/6950 (0%)	1
Dysuria	1/6950 (0%)	1	0/6950 (0%)	0
Glomerulonephritis	0/6950 (0%)	0	1/6950 (0%)	1
Haematuria	3/6950 (0%)	3	2/6950 (0%)	2
Hydronephrosis	1/6950 (0%)	1	0/6950 (0%)	0
Nephroangiosclerosis	1/6950 (0%)	1	0/6950 (0%)	0
Nephrolithiasis	6/6950 (0.1%)	6	2/6950 (0%)	2
Nephropathy toxic	0/6950 (0%)	0	1/6950 (0%)	1
Neurogenic bladder	0/6950 (0%)	0	1/6950 (0%)	1
Prerenal failure	0/6950 (0%)	0	2/6950 (0%)	2
Renal cyst	2/6950 (0%)	2	1/6950 (0%)	1
Renal disorder	1/6950 (0%)	1	0/6950 (0%)	0
Renal failure	11/6950 (0.2%)	11	11/6950 (0.2%)	12
Renal hypertension	0/6950 (0%)	0	1/6950 (0%)	1
Renal mass	1/6950 (0%)	1	0/6950 (0%)	0
Tubulointerstitial nephritis	0/6950 (0%)	0	4/6950 (0.1%)	4
Urethral haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Urethral meatus stenosis	1/6950 (0%)	1	0/6950 (0%)	0
Urethral stenosis	2/6950 (0%)	2	2/6950 (0%)	2
Urinary incontinence	1/6950 (0%)	1	0/6950 (0%)	0
Urinary retention	3/6950 (0%)	3	3/6950 (0%)	3
Urinary tract disorder	1/6950 (0%)	1	1/6950 (0%)	1
Reproductive system and breast disorders
Atrophic vulvovaginitis	1/6950 (0%)	1	0/6950 (0%)	0
Benign prostatic hyperplasia	9/6950 (0.1%)	9	7/6950 (0.1%)	7
Breast dysplasia	1/6950 (0%)	1	0/6950 (0%)	0
Ovarian cyst	1/6950 (0%)	1	0/6950 (0%)	0
Prostatic obstruction	0/6950 (0%)	0	2/6950 (0%)	2
Prostatitis	1/6950 (0%)	1	2/6950 (0%)	2
Prostatomegaly	1/6950 (0%)	1	0/6950 (0%)	0
Rectocele	1/6950 (0%)	1	1/6950 (0%)	1
Uterine polyp	0/6950 (0%)	0	1/6950 (0%)	1
Uterine prolapse	0/6950 (0%)	0	4/6950 (0.1%)	4
Vaginal haemorrhage	1/6950 (0%)	1	0/6950 (0%)	0
Vaginal prolapse	0/6950 (0%)	0	1/6950 (0%)	1
Vaginal ulceration	0/6950 (0%)	0	1/6950 (0%)	1
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	2/6950 (0%)	2	3/6950 (0%)	3
Acute respiratory failure	2/6950 (0%)	2	4/6950 (0.1%)	5
Aspiration	0/6950 (0%)	0	1/6950 (0%)	1
Asthma	2/6950 (0%)	2	4/6950 (0.1%)	4
Atelectasis	0/6950 (0%)	0	1/6950 (0%)	1
Bronchiectasis	1/6950 (0%)	1	0/6950 (0%)	0
Bronchitis chronic	0/6950 (0%)	0	2/6950 (0%)	2
Bronchospasm	0/6950 (0%)	0	1/6950 (0%)	1
Chronic obstructive pulmonary disease	21/6950 (0.3%)	26	18/6950 (0.3%)	18
Diaphragmatic disorder	0/6950 (0%)	0	1/6950 (0%)	1
Dyspnoea	2/6950 (0%)	2	4/6950 (0.1%)	4
Emphysema	0/6950 (0%)	0	1/6950 (0%)	1
Epistaxis	1/6950 (0%)	1	3/6950 (0%)	3
Haemoptysis	3/6950 (0%)	3	0/6950 (0%)	0
Haemothorax	0/6950 (0%)	0	1/6950 (0%)	1
Hyperventilation	1/6950 (0%)	1	0/6950 (0%)	0
Hypoxia	0/6950 (0%)	0	2/6950 (0%)	2
Interstitial lung disease	1/6950 (0%)	1	1/6950 (0%)	1
Lung disorder	0/6950 (0%)	0	2/6950 (0%)	2
Nasal septum deviation	1/6950 (0%)	1	1/6950 (0%)	1
Pleural effusion	5/6950 (0.1%)	6	8/6950 (0.1%)	8
Pleurisy	1/6950 (0%)	1	0/6950 (0%)	0
Pleuritic pain	0/6950 (0%)	0	1/6950 (0%)	1
Pneumonia aspiration	10/6950 (0.1%)	10	3/6950 (0%)	3
Pneumothorax	0/6950 (0%)	0	2/6950 (0%)	2
Pulmonary cavitation	1/6950 (0%)	1	0/6950 (0%)	0
Pulmonary congestion	1/6950 (0%)	1	1/6950 (0%)	1
Pulmonary embolism	15/6950 (0.2%)	15	21/6950 (0.3%)	21
Pulmonary fibrosis	0/6950 (0%)	0	3/6950 (0%)	3
Pulmonary mass	0/6950 (0%)	0	1/6950 (0%)	1
Pulmonary oedema	2/6950 (0%)	2	4/6950 (0.1%)	4
Respiratory arrest	3/6950 (0%)	3	0/6950 (0%)	0
Respiratory distress	2/6950 (0%)	2	2/6950 (0%)	2
Respiratory failure	15/6950 (0.2%)	15	15/6950 (0.2%)	15
Skin and subcutaneous tissue disorders
Actinic keratosis	1/6950 (0%)	1	0/6950 (0%)	0
Angioedema	1/6950 (0%)	1	0/6950 (0%)	0
Decubitus ulcer	1/6950 (0%)	1	2/6950 (0%)	2
Dermal cyst	0/6950 (0%)	0	1/6950 (0%)	1
Dermatitis allergic	1/6950 (0%)	1	0/6950 (0%)	0
Dermatitis contact	1/6950 (0%)	1	1/6950 (0%)	1
Dermatomyositis	0/6950 (0%)	0	1/6950 (0%)	1
Diabetic foot	0/6950 (0%)	0	5/6950 (0.1%)	5
Drug eruption	0/6950 (0%)	0	1/6950 (0%)	1
Eczema	2/6950 (0%)	2	1/6950 (0%)	1
Lichen planus	1/6950 (0%)	1	0/6950 (0%)	0
Skin necrosis	0/6950 (0%)	0	2/6950 (0%)	2
Skin ulcer	1/6950 (0%)	1	1/6950 (0%)	1
Stasis dermatitis	1/6950 (0%)	1	0/6950 (0%)	0
Urticaria	1/6950 (0%)	1	0/6950 (0%)	0
Surgical and medical procedures
Hospitalisation	0/6950 (0%)	0	1/6950 (0%)	1
Rectal polypectomy	1/6950 (0%)	1	0/6950 (0%)	0
Vascular disorders
Aneurysm	0/6950 (0%)	0	1/6950 (0%)	1
Aneurysm ruptured	1/6950 (0%)	1	1/6950 (0%)	1
Aortic aneurysm	6/6950 (0.1%)	6	2/6950 (0%)	2
Aortic aneurysm rupture	4/6950 (0.1%)	4	4/6950 (0.1%)	4
Aortic arteriosclerosis	0/6950 (0%)	0	1/6950 (0%)	1
Aortic dissection	1/6950 (0%)	1	2/6950 (0%)	2
Aortic occlusion	1/6950 (0%)	1	0/6950 (0%)	0
Aortic rupture	0/6950 (0%)	0	1/6950 (0%)	1
Aortic stenosis	0/6950 (0%)	0	8/6950 (0.1%)	8
Arteriosclerosis	1/6950 (0%)	1	5/6950 (0.1%)	7
Arteriovenous fistula	1/6950 (0%)	1	0/6950 (0%)	0
Blood pressure inadequately controlled	0/6950 (0%)	0	1/6950 (0%)	1
Circulatory collapse	5/6950 (0.1%)	5	3/6950 (0%)	3
Deep vein thrombosis	6/6950 (0.1%)	6	9/6950 (0.1%)	10
Embolism	1/6950 (0%)	1	1/6950 (0%)	1
Femoral artery aneurysm	1/6950 (0%)	1	0/6950 (0%)	0
Femoral artery occlusion	0/6950 (0%)	0	1/6950 (0%)	1
Haematoma	1/6950 (0%)	1	6/6950 (0.1%)	6
Haemorrhage	1/6950 (0%)	1	3/6950 (0%)	3
Hypertension	22/6950 (0.3%)	22	25/6950 (0.4%)	27
Hypertensive crisis	7/6950 (0.1%)	8	6/6950 (0.1%)	6
Hypertensive emergency	0/6950 (0%)	0	1/6950 (0%)	1
Hypotension	6/6950 (0.1%)	6	5/6950 (0.1%)	5
Inferior vena caval occlusion	0/6950 (0%)	0	1/6950 (0%)	1
Intermittent claudication	0/6950 (0%)	0	2/6950 (0%)	2
Internal haemorrhage	2/6950 (0%)	2	0/6950 (0%)	0
Labile hypertension	1/6950 (0%)	1	0/6950 (0%)	0
Microscopic polyangiitis	0/6950 (0%)	0	1/6950 (0%)	1
Necrosis ischaemic	1/6950 (0%)	1	0/6950 (0%)	0
Orthostatic hypotension	2/6950 (0%)	2	4/6950 (0.1%)	4
Peripheral arterial occlusive disease	6/6950 (0.1%)	6	6/6950 (0.1%)	6
Peripheral artery aneurysm	0/6950 (0%)	0	1/6950 (0%)	1
Peripheral artery stenosis	0/6950 (0%)	0	1/6950 (0%)	1
Peripheral ischaemia	1/6950 (0%)	1	0/6950 (0%)	0
Peripheral vascular disorder	1/6950 (0%)	1	0/6950 (0%)	0
Shock haemorrhagic	1/6950 (0%)	1	0/6950 (0%)	0
Temporal arteritis	1/6950 (0%)	1	1/6950 (0%)	1
Thromboangiitis obliterans	0/6950 (0%)	0	1/6950 (0%)	1
Thrombophlebitis	1/6950 (0%)	1	0/6950 (0%)	0
Thrombosis	1/6950 (0%)	1	2/6950 (0%)	2
Varicose vein	0/6950 (0%)	0	1/6950 (0%)	1
Vasculitis	1/6950 (0%)	1	0/6950 (0%)	0
Venous thrombosis	1/6950 (0%)	1	0/6950 (0%)	0
Venous thrombosis limb	1/6950 (0%)	1	1/6950 (0%)	1
Other (Not Including Serious) Adverse Events
	Zoster-022 GSK1437173A Group		Zoster-022 Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3067/6950 (44.1%)		610/6950 (8.8%)
General disorders
Chills	353/6950 (5.1%)	415	39/6950 (0.6%)	46
Fatigue	474/6950 (6.8%)	592	169/6950 (2.4%)	192
Injection site erythema	864/6950 (12.4%)	1150	27/6950 (0.4%)	29
Injection site pain	1975/6950 (28.4%)	2762	148/6950 (2.1%)	165
Injection site swelling	613/6950 (8.8%)	773	16/6950 (0.2%)	18
Pain	428/6950 (6.2%)	669	60/6950 (0.9%)	67
Pyrexia	535/6950 (7.7%)	633	52/6950 (0.7%)	56
Musculoskeletal and connective tissue disorders
Myalgia	378/6950 (5.4%)	472	99/6950 (1.4%)	113
Nervous system disorders
Headache	586/6950 (8.4%)	717	243/6950 (3.5%)	307

Limitations/Caveats

[Not Specified]

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

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