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Trial record 1 of 1 for:    NCT01767467
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Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01767467
Recruitment Status : Completed
First Posted : January 14, 2013
Results First Posted : May 25, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Herpes Zoster
Interventions Biological: Herpes zoster vaccine (GSK 1437173A)
Drug: Placebo
Enrollment 568
Recruitment Details  
Pre-assignment Details Out of the 568 subjects enrolled, only 562 subjects received vaccination as per protocol and hence started the study.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose). Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Period Title: Vaccination Phase (up to Month 2)
Started 283 279
Completed 266 259
Not Completed 17 20
Reason Not Completed
Adverse Event             8             8
Protocol Violation             1             0
Withdrawal by Subject             7             10
Suspected Herpes Zoster episode             0             1
Physician Decision             1             0
Subject unavailable             0             1
Period Title: End of Study Phase (up to Month 13)
Started 283 279
Completed 236 216
Not Completed 47 63
Reason Not Completed
Adverse Event             29             39
Protocol Violation             2             0
Withdrawal by Subject             9             14
Migrated/Moved from study area             0             3
Lost to Follow-up             6             4
Suspected Herpes Zoster episode             0             1
Physician Decision             1             0
Subject Unavailable             0             2
Arm/Group Title GSK1437173A Group Placebo Group Total
Hide Arm/Group Description Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose). Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose). Total of all reporting groups
Overall Number of Baseline Participants 283 279 562
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 279 participants 562 participants
56.8  (15.5) 57.8  (14.9) 57.3  (15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 279 participants 562 participants
Female
114
  40.3%
114
  40.9%
228
  40.6%
Male
169
  59.7%
165
  59.1%
334
  59.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 283 participants 279 participants 562 participants
African Heritage / African American
1
   0.4%
1
   0.4%
2
   0.4%
American Indian or Alaskan Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian - Central / South Asian Heritage
5
   1.8%
6
   2.2%
11
   2.0%
Asian - East Asian Heritage
57
  20.1%
60
  21.5%
117
  20.8%
Asian - South East Asian Heritage
4
   1.4%
1
   0.4%
5
   0.9%
White - Arabic / North African Heritage
0
   0.0%
1
   0.4%
1
   0.2%
White - Caucasian / European Heritage
198
  70.0%
186
  66.7%
384
  68.3%
Other
7
   2.5%
12
   4.3%
19
   3.4%
Missing
11
   3.9%
11
   3.9%
22
   3.9%
1.Primary Outcome
Title Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations
Hide Description

Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration.

This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.

Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 148 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
80.4
(73.1 to 86.5)
0.8
(0.0 to 4.2)
2.Primary Outcome
Title Adjusted Geometric Mean Concentration of Anti-gE Antibodies
Hide Description The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 148 130
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
22132.9
(16642.8 to 32153.9)
777.6
(702.8 to 860.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1437173A Group, Placebo Group
Comments The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
Type of Statistical Test Non-Inferiority
Comments The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (>) 3.
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1
Method Repeated measurement model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Geometric Mean Concentration
Estimated Value 29.75
Confidence Interval (2-Sided) 95%
21.09 to 41.96
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 278 274
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 278 participants 271 participants
199
  71.6%
26
   9.6%
Grade 3 Pain, Dose 1 Number Analyzed 278 participants 271 participants
16
   5.8%
0
   0.0%
Any Redness, Dose 1 Number Analyzed 278 participants 271 participants
80
  28.8%
1
   0.4%
Grade 3 Redness, Dose 1 Number Analyzed 278 participants 271 participants
2
   0.7%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 278 participants 271 participants
47
  16.9%
2
   0.7%
Grade 3 Swelling, Dose 1 Number Analyzed 278 participants 271 participants
1
   0.4%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 255 participants 248 participants
172
  67.5%
31
  12.5%
Grade 3 Pain, Dose 2 Number Analyzed 255 participants 248 participants
20
   7.8%
0
   0.0%
Any Redness, Dose 2 Number Analyzed 255 participants 248 participants
82
  32.2%
5
   2.0%
Grade 3 Redness, Dose 2 Number Analyzed 255 participants 248 participants
10
   3.9%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 255 participants 248 participants
42
  16.5%
1
   0.4%
Grade 3 Swelling, Dose 2 Number Analyzed 255 participants 248 participants
5
   2.0%
0
   0.0%
Any Pain, Across doses Number Analyzed 278 participants 274 participants
221
  79.5%
45
  16.4%
Grade 3 Pain, Across doses Number Analyzed 278 participants 274 participants
29
  10.4%
0
   0.0%
Any Redness, Across doses Number Analyzed 278 participants 274 participants
115
  41.4%
5
   1.8%
Grade 3 Redness, Across doses Number Analyzed 278 participants 274 participants
12
   4.3%
0
   0.0%
Any Swelling, Across doses Number Analyzed 278 participants 274 participants
63
  22.7%
2
   0.7%
Grade 3 Swelling, Across doses Number Analyzed 278 participants 274 participants
5
   1.8%
0
   0.0%
4.Primary Outcome
Title Number of Days With Solicited Local Symptoms
Hide Description Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.
Time Frame Within the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 278 271
Median (Inter-Quartile Range)
Unit of Measure: Days
Pain, Dose 1 Number Analyzed 278 participants 271 participants
3.0
(2.0 to 4.0)
1.0
(1.0 to 2.0)
Pain, Dose 2 Number Analyzed 255 participants 248 participants
3.0
(2.0 to 4.0)
2.0
(1.0 to 3.0)
Redness, Dose 1 Number Analyzed 278 participants 271 participants
3.0
(2.0 to 5.0)
1.0
(1.0 to 1.0)
Redness, Dose 2 Number Analyzed 255 participants 248 participants
3.0
(2.0 to 5.0)
4.0
(2.0 to 6.0)
Swelling, Dose 1 Number Analyzed 278 participants 271 participants
3.0
(2.0 to 4.0)
1.5
(1.0 to 2.0)
Swelling, Dose 2 Number Analyzed 255 participants 248 participants
3.0
(2.0 to 4.0)
4.0
(4.0 to 4.0)
5.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 278 274
Measure Type: Count of Participants
Unit of Measure: Participants
Any fatigue, Dose 1 Number Analyzed 278 participants 271 participants
122
  43.9%
73
  26.9%
Grade 3 fatigue, Dose 1 Number Analyzed 278 participants 271 participants
11
   4.0%
8
   3.0%
Related fatigue, Dose 1 Number Analyzed 278 participants 271 participants
37
  13.3%
11
   4.1%
Any gastrointestinal, Dose 1 Number Analyzed 278 participants 271 participants
48
  17.3%
24
   8.9%
Grade 3 gastrointestinal, Dose 1 Number Analyzed 278 participants 271 participants
5
   1.8%
2
   0.7%
Related gastrointestinal, Dose 1 Number Analyzed 278 participants 271 participants
13
   4.7%
1
   0.4%
Any headache, Dose 1 Number Analyzed 278 participants 271 participants
70
  25.2%
40
  14.8%
Grade 3 headache, Dose 1 Number Analyzed 278 participants 271 participants
3
   1.1%
3
   1.1%
Related headache, Dose 1 Number Analyzed 278 participants 271 participants
29
  10.4%
10
   3.7%
Any myalgia, Dose 1 Number Analyzed 278 participants 271 participants
80
  28.8%
35
  12.9%
Grade 3 myalgia, Dose 1 Number Analyzed 278 participants 271 participants
11
   4.0%
0
   0.0%
Related myalgia, Dose 1 Number Analyzed 278 participants 271 participants
33
  11.9%
10
   3.7%
Any shivering, Dose 1 Number Analyzed 278 participants 271 participants
39
  14.0%
16
   5.9%
Grade 3 shivering, Dose 1 Number Analyzed 278 participants 271 participants
2
   0.7%
0
   0.0%
Related shivering, Dose 1 Number Analyzed 278 participants 271 participants
14
   5.0%
2
   0.7%
Any temperature, Dose 1 Number Analyzed 278 participants 271 participants
33
  11.9%
15
   5.5%
Grade 3 temperature, Dose 1 Number Analyzed 278 participants 271 participants
0
   0.0%
1
   0.4%
Related temperature, Dose 1 Number Analyzed 278 participants 271 participants
18
   6.5%
3
   1.1%
Any fatigue, Dose 2 Number Analyzed 255 participants 247 participants
126
  49.4%
67
  27.1%
Grade 3 fatigue, Dose 2 Number Analyzed 255 participants 247 participants
16
   6.3%
6
   2.4%
Related fatigue, Dose 2 Number Analyzed 255 participants 247 participants
49
  19.2%
13
   5.3%
Any gastrointestinal, Dose 2 Number Analyzed 255 participants 247 participants
53
  20.8%
16
   6.5%
Grade 3 gastrointestinal, Dose 2 Number Analyzed 255 participants 247 participants
5
   2.0%
2
   0.8%
Related gastrointestinal, Dose 2 Number Analyzed 255 participants 247 participants
20
   7.8%
4
   1.6%
Any headache, Dose 2 Number Analyzed 255 participants 247 participants
90
  35.3%
42
  17.0%
Grade 3 headache, Dose 2 Number Analyzed 255 participants 247 participants
10
   3.9%
3
   1.2%
Related headache, Dose 2 Number Analyzed 255 participants 247 participants
42
  16.5%
9
   3.6%
Any myalgia, Dose 2 Number Analyzed 255 participants 247 participants
93
  36.5%
25
  10.1%
Grade 3 myalgia, Dose 2 Number Analyzed 255 participants 247 participants
14
   5.5%
5
   2.0%
Related myalgia, Dose 2 Number Analyzed 255 participants 247 participants
50
  19.6%
7
   2.8%
Any shivering, Dose 2 Number Analyzed 255 participants 247 participants
48
  18.8%
7
   2.8%
Grade 3 shivering, Dose 2 Number Analyzed 255 participants 247 participants
9
   3.5%
0
   0.0%
Related shivering, Dose 2 Number Analyzed 255 participants 247 participants
27
  10.6%
1
   0.4%
Any temperature, Dose 2 Number Analyzed 255 participants 247 participants
51
  20.0%
11
   4.5%
Grade 3 teamperature, Dose 2 Number Analyzed 255 participants 247 participants
3
   1.2%
0
   0.0%
Related temperature, Dose 2 Number Analyzed 255 participants 247 participants
28
  11.0%
3
   1.2%
Any fatigue, Across doses Number Analyzed 278 participants 274 participants
162
  58.3%
102
  37.2%
Grade 3 fatigue, Across doses Number Analyzed 278 participants 274 participants
23
   8.3%
10
   3.6%
Related fatigue, Across doses Number Analyzed 278 participants 274 participants
63
  22.7%
22
   8.0%
Any gastrointestinal, Across doses Number Analyzed 278 participants 274 participants
76
  27.3%
29
  10.6%
Grade 3 gastrointestinal, Across doses Number Analyzed 278 participants 274 participants
9
   3.2%
3
   1.1%
Related gastrointestinal, Across doses Number Analyzed 278 participants 274 participants
28
  10.1%
5
   1.8%
Any headache, Across doses Number Analyzed 278 participants 274 participants
115
  41.4%
64
  23.4%
Grade 3 headache, Across doses Number Analyzed 278 participants 274 participants
12
   4.3%
6
   2.2%
Related headache, Across doses Number Analyzed 278 participants 274 participants
52
  18.7%
16
   5.8%
Any myalgia, Across doses Number Analyzed 278 participants 274 participants
122
  43.9%
48
  17.5%
Grade 3 myalgia, Across doses Number Analyzed 278 participants 274 participants
22
   7.9%
5
   1.8%
Related myalgia, Across doses Number Analyzed 278 participants 274 participants
63
  22.7%
15
   5.5%
Any shivering, Across doses Number Analyzed 278 participants 274 participants
69
  24.8%
18
   6.6%
Grade 3 shivering, Across doses Number Analyzed 278 participants 274 participants
11
   4.0%
0
   0.0%
Related shivering, Across doses Number Analyzed 278 participants 274 participants
36
  12.9%
2
   0.7%
Any temperature, Across doses Number Analyzed 278 participants 274 participants
68
  24.5%
21
   7.7%
Grade 3 temperature, Across doses Number Analyzed 278 participants 274 participants
3
   1.1%
1
   0.4%
Related teamperature, Across doses Number Analyzed 278 participants 274 participants
36
  12.9%
4
   1.5%
6.Primary Outcome
Title Number of Days With Solicited General Symptoms
Hide Description Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.
Time Frame Withing the 7-day (Day 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose)
Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose)
Overall Number of Participants Analyzed 278 271
Median (Inter-Quartile Range)
Unit of Measure: Days
Fatigue, Dose 1 Number Analyzed 278 participants 271 participants
3.0
(1.0 to 6.0)
3.0
(2.0 to 7.0)
Fatigue, Dose 2 Number Analyzed 255 participants 247 participants
3.0
(2.0 to 5.0)
3.0
(1.0 to 7.0)
Gastrointestinal symptoms, Dose 1 Number Analyzed 278 participants 271 participants
2.5
(1.0 to 5.0)
3.5
(1.5 to 6.0)
Gastrointestinal symptoms, Dose 2 Number Analyzed 255 participants 247 participants
2.0
(1.0 to 3.0)
6.0
(2.5 to 7.0)
Headache, Dose 1 Number Analyzed 278 participants 271 participants
2.0
(1.0 to 3.0)
1.5
(1.0 to 3.0)
Headache, Dose 2 Number Analyzed 255 participants 247 participants
2.0
(1.0 to 3.0)
1.0
(1.0 to 3.0)
Myalgia, Dose 1 Number Analyzed 278 participants 271 participants
3.5
(2.0 to 5.5)
3.0
(1.0 to 4.0)
Myalgia, Dose 2 Number Analyzed 255 participants 247 participants
2.0
(2.0 to 4.0)
3.0
(1.0 to 7.0)
Shivering, Dose 1 Number Analyzed 278 participants 271 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.5)
Shivering, Dose 2 Number Analyzed 255 participants 247 participants
1.0
(1.0 to 2.0)
4.0
(2.0 to 4.0)
Temperature, Dose 1 Number Analyzed 278 participants 271 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 3.0)
Temperature, Dose 2 Number Analyzed 255 participants 247 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 4.0)
7.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study. It also included 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-day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all all subjects with at least one vaccine dose administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 283 279
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
134
  47.3%
128
  45.9%
Grade 3 AEs
25
   8.8%
28
  10.0%
Related AEs
19
   6.7%
5
   1.8%
8.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination
Time Frame From first vaccination up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 283 279
Measure Type: Count of Participants
Unit of Measure: Participants
At least one SAE
17
   6.0%
29
  10.4%
Related SAEs
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMds assessed by the investigator as causally related to the study vaccination
Time Frame From first vaccination up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 283 279
Measure Type: Count of Participants
Unit of Measure: Participants
Any pIMDs
1
   0.4%
0
   0.0%
Related pIMDs
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Hide Description Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 184 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
69.0
(61.8 to 75.6)
0.6
(0.0 to 3.3)
11.Secondary Outcome
Title Anti-gE Antibody Concentrations
Hide Description Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 184 165
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
15795.5
(11603.3 to 21502.2)
791.6
(648.9 to 965.5)
12.Secondary Outcome
Title Time to Occurrence of Any Confirmed HZ Case
Hide Description

Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination.

Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method.

Time Frame From Month 0 until study end (Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 283 279
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Person-year rate
0.020
(0.009 to 0.045)
0.071
(0.045 to 0.111)
13.Secondary Outcome
Title Anti-gE Antibody Concentrations
Hide Description Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.
Time Frame At Months 0, 1, 2 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 217 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-gE, Month 0 Number Analyzed 217 participants 198 participants
964.0
(814.5 to 1140.8)
883.7
(749.9 to 1041.4)
Anti-gE, Month 1 Number Analyzed 215 participants 196 participants
4216.5
(3328.6 to 5341.4)
824.2
(699.4 to 971.3)
Anti-gE, Month 2 Number Analyzed 217 participants 198 participants
13445.6
(10158.9 to 17795.6)
832.0
(701.1 to 987.3)
Anti-gE, Month 13 Number Analyzed 167 participants 142 participants
5202.7
(4074.8 to 6642.8)
895.4
(734.5 to 1091.5)
14.Secondary Outcome
Title Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations
Hide Description Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.
Time Frame At Months 1, 2 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 217 198
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
VRR, anti-gE, Month 1 Number Analyzed 215 participants 196 participants
44.2
(37.4 to 51.1)
0.0
(0.0 to 1.9)
VRR, anti-gE, Month 2 Number Analyzed 217 participants 198 participants
65.4
(58.7 to 71.7)
0.5
(0.0 to 2.8)
VRR, anti-gE, Month 13 Number Analyzed 165 participants 140 participants
52.1
(44.2 to 59.9)
3.6
(1.2 to 8.1)
15.Secondary Outcome
Title Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers
Hide Description Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).
Time Frame At Months 0, 1, 2 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the adapted ATP cohort for Cell-Mediated Immunogenicity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 58 51
Mean (Standard Deviation)
Unit of Measure: CD4 [2+] T-cells/million T-cells
CD4 [2+], Month 0 Number Analyzed 52 participants 49 participants
226.78  (659.84) 147.30  (191.91)
CD4 [2+], Month 1 Number Analyzed 58 participants 51 participants
1261.67  (2318.36) 196.74  (332.52)
CD4 [2+], Month 2 Number Analyzed 53 participants 50 participants
6083.98  (10467.57) 318.20  (1000.90)
CD4 [2+], Month 13 Number Analyzed 44 participants 36 participants
3626.87  (7758.18) 181.23  (387.90)
16.Secondary Outcome
Title Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers
Hide Description

Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as:

For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells).

For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.

Time Frame At Months 1, 2 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the adapted ATP cohort for Cell Mediated Immunity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 48 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
CD4 [2+], Month 1 Number Analyzed 48 participants 47 participants
37.5
(24.0 to 52.6)
2.1
(0.1 to 11.3)
CD4 [2+], Month 2 Number Analyzed 43 participants 44 participants
83.7
(69.3 to 93.2)
6.8
(1.4 to 18.7)
CD4 [2+], Month 13 Number Analyzed 33 participants 31 participants
66.7
(48.2 to 82.0)
6.5
(0.8 to 21.4)
17.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination
Time Frame From first vaccination at Month 0 up to study end at Month 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 283 279
Measure Type: Count of Participants
Unit of Measure: Participants
At least one SAE, up to Month 6
50
  17.7%
60
  21.5%
Related SAEs, up to Month 6
0
   0.0%
1
   0.4%
At least one SAE, up to Month 13
66
  23.3%
82
  29.4%
Related SAEs, up to Month 13
1
   0.4%
1
   0.4%
18.Secondary Outcome
Title Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Time Frame From first vaccination at Month 0 up to study end at Month 13
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Overall Number of Participants Analyzed 283 279
Measure Type: Count of Participants
Unit of Measure: Participants
Up to Month 6
3
   1.1%
1
   0.4%
Up to Month 13
3
   1.1%
2
   0.7%
19.Secondary Outcome
Title Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies
Hide Description GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).
Time Frame At Months 0 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling.
Arm/Group Title GSK1437173A HZ Cases Sub-Group GSK1437173A Non-HZ Cases Sub-Group Placebo HZ Cases Sub-Group Placebo Non-HZ Cases Sub-Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Overall Number of Participants Analyzed 2 257 12 240
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/ml
PRE
115.9
(0.0 to 7406196)
973.6
(835.6 to 1134.4)
984.5
(500.7 to 1935.7)
866.3
(745.5 to 1006.6)
Month 2
184.0
(0.0 to 4187800000)
12517.4
(9662.0 to 16216.6)
960.5
(454.2 to 2031.1)
802.9
(686.7 to 938.9)
20.Secondary Outcome
Title Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations
Hide Description MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling, only on the subjects with available results at Month 2.
Arm/Group Title GSK1437173A HZ Cases Sub-Group GSK1437173A Non-HZ Cases Sub-Group Placebo HZ Cases Sub-Group Placebo Non-HZ Cases Sub-Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Overall Number of Participants Analyzed 2 253 12 233
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
1.59
(0.00 to 565.45)
13.07
(9.93 to 17.22)
0.98
(0.80 to 1.19)
0.94
(0.88 to 1.00)
Time Frame Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose). Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
All-Cause Mortality
GSK1437173A Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   29/283 (10.25%)      37/279 (13.26%)    
Hide Serious Adverse Events
GSK1437173A Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/283 (23.32%)      82/279 (29.39%)    
Blood and lymphatic system disorders     
Anaemia  1  1/283 (0.35%)  1 1/279 (0.36%)  1
Coagulopathy  1  1/283 (0.35%)  2 0/279 (0.00%)  0
Cytopenia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Febrile neutropenia  1  14/283 (4.95%)  16 11/279 (3.94%)  16
Neutropenia  1  3/283 (1.06%)  4 2/279 (0.72%)  2
Normochromic normocytic anaemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pancytopenia  1  2/283 (0.71%)  3 2/279 (0.72%)  2
Thrombocytopenia  1  4/283 (1.41%)  4 1/279 (0.36%)  4
Cardiac disorders     
Cardiac arrest  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Cardiac failure  1  2/283 (0.71%)  2 0/279 (0.00%)  0
Cardiac failure congestive  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Cardiovascular disorder  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Myocardial infarction  1  1/283 (0.35%)  1 1/279 (0.36%)  1
Myocarditis  1  0/283 (0.00%)  0 2/279 (0.72%)  2
Pericardial effusion  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Ear and labyrinth disorders     
Deafness neurosensory  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Eye disorders     
Conjunctival haemorrhage  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Ophthalmoplegia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Gastrointestinal disorders     
Anal fistula  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Ascites  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Chronic gastritis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Diarrhoea  1  0/283 (0.00%)  0 2/279 (0.72%)  2
Gastric haemorrhage  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Gastrointestinal haemorrhage  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Gastrooesophageal reflux disease  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Ileus  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Ileus paralytic  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Inguinal hernia  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Intestinal obstruction  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Nausea  1  0/283 (0.00%)  0 1/279 (0.36%)  1
General disorders     
Adhesion  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Asthenia  1  3/283 (1.06%)  3 2/279 (0.72%)  2
Chest pain  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Chills  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Death neonatal  1  1/283 (0.35%)  1 0/279 (0.00%)  0
General physical health deterioration  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Malaise  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Mucosal inflammation  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Multiple organ dysfunction syndrome  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Nodule  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Oedema peripheral  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pyrexia  1  3/283 (1.06%)  4 3/279 (1.08%)  3
Hepatobiliary disorders     
Acute hepatic failure  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Hepatitis fulminant  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Immune system disorders     
Acute graft versus host disease in skin  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Anaphylactic shock  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Graft versus host disease  1  1/283 (0.35%)  2 1/279 (0.36%)  1
Graft versus host disease in gastrointestinal tract  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Graft versus host disease in liver  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Infections and infestations     
Aspergillus infection  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Bacteraemia  1  1/283 (0.35%)  1 1/279 (0.36%)  1
Bacterial infection  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Bacterial sepsis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Bronchitis  1  1/283 (0.35%)  1 1/279 (0.36%)  1
Bronchopulmonary aspergillosis  1  3/283 (1.06%)  3 0/279 (0.00%)  0
Campylobacter colitis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Cellulitis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Chronic sinusitis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Corynebacterium bacteraemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Cytomegalovirus colitis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Cytomegalovirus infection  1  2/283 (0.71%)  2 0/279 (0.00%)  0
Diverticulitis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Ecthyma  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Epiglottitis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Escherichia bacteraemia  1  1/283 (0.35%)  2 0/279 (0.00%)  0
Fungal infection  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Gastroenteritis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Gastroenteritis viral  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Hepatitis b  1  2/283 (0.71%)  2 0/279 (0.00%)  0
Herpes zoster  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Infected skin ulcer  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Infection  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Lower respiratory tract infection  1  1/283 (0.35%)  1 2/279 (0.72%)  2
Lung infection  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Meningitis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Meningitis aseptic  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Meningitis cryptococcal  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Otitis externa  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Otitis media  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Perichondritis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pharyngotonsillitis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pneumocystis jirovecii infection  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pneumocystis jirovecii pneumonia  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pneumonia  1  11/283 (3.89%)  12 11/279 (3.94%)  12
Pneumonia cytomegaloviral  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pneumonia fungal  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pneumonia klebsiella  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pneumonia parainfluenzae viral  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pneumonia respiratory syncytial viral  1  2/283 (0.71%)  3 1/279 (0.36%)  1
Pneumonia streptococcal  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pulmonary mycosis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pyelonephritis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pyelonephritis acute  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pyomyositis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Respiratory tract infection  1  3/283 (1.06%)  3 2/279 (0.72%)  2
Respiratory tract infection viral  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Sepsis  1  5/283 (1.77%)  5 6/279 (2.15%)  6
Septic shock  1  3/283 (1.06%)  3 3/279 (1.08%)  3
Sinusitis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Staphylococcal bacteraemia  1  3/283 (1.06%)  4 1/279 (0.36%)  1
Staphylococcal infection  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Streptococcal bacteraemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Subcutaneous abscess  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Systemic candida  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Tooth abscess  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Tuberculosis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Upper respiratory tract infection  1  2/283 (0.71%)  2 0/279 (0.00%)  0
Urinary tract infection  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Urosepsis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Varicella zoster virus infection  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Injury, poisoning and procedural complications     
Fall  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Femoral neck fracture  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Foreign body in gastrointestinal tract  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Humerus fracture  1  1/283 (0.35%)  1 2/279 (0.72%)  2
Laceration  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Multiple fractures  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Overdose  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Spinal compression fracture  1  0/283 (0.00%)  0 2/279 (0.72%)  3
Tibia fracture  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Investigations     
Oxygen saturation decreased  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Fluid retention  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Hypokalaemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Type 2 diabetes mellitus  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Musculoskeletal and connective tissue disorders     
Fasciitis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Intervertebral disc disorder  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Intervertebral disc protrusion  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Spondylolisthesis  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia  1  2/283 (0.71%)  2 1/279 (0.36%)  1
Acute myeloid leukaemia  1  3/283 (1.06%)  3 8/279 (2.87%)  8
Anaplastic large-cell lymphoma  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Blastic plasmacytoid dendritic cell neoplasia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Brain neoplasm  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Cervix cancer metastatic  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Chronic lymphocytic leukaemia  1  1/283 (0.35%)  1 2/279 (0.72%)  2
Haemangioma  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Hodgkin's disease  1  3/283 (1.06%)  3 1/279 (0.36%)  1
Leukaemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Malignant melanoma  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Metastases to liver  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Metastases to peritoneum  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Myelodysplastic syndrome  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Myeloid leukaemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Non-hodgkin's lymphoma  1  1/283 (0.35%)  1 2/279 (0.72%)  2
Plasma cell leukaemia  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Plasma cell myeloma  1  2/283 (0.71%)  2 6/279 (2.15%)  6
Post transplant lymphoproliferative disorder  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Precursor t-lymphoblastic lymphoma/leukaemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
T-cell lymphoma  1  0/283 (0.00%)  0 2/279 (0.72%)  2
T-cell type acute leukaemia  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Nervous system disorders     
Cerebral haemorrhage  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Cerebral infarction  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Cerebrovascular accident  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Dysarthria  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Guillain-barre syndrome  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Haemorrhage intracranial  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Haemorrhagic transformation stroke  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Hepatic encephalopathy  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Loss of consciousness  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Parkinsonism  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Post herpetic neuralgia  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Syncope  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Psychiatric disorders     
Disorientation  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  5/283 (1.77%)  5 4/279 (1.43%)  4
Hydronephrosis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Urinary tract obstruction  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Renal failure  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Ovarian cyst ruptured  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Dyspnoea  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pleural effusion  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pneumonia aspiration  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pneumonitis  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Pneumothorax  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Pulmonary embolism  1  0/283 (0.00%)  0 2/279 (0.72%)  2
Respiratory failure  1  2/283 (0.71%)  2 2/279 (0.72%)  2
Rhinorrhoea  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Erythema nodosum  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Rash  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Surgical and medical procedures     
Finger amputation  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Stem cell transplant  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Vascular disorders     
Deep vein thrombosis  1  1/283 (0.35%)  1 1/279 (0.36%)  1
Embolism  1  0/283 (0.00%)  0 1/279 (0.36%)  1
Hypotension  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Ischaemia  1  1/283 (0.35%)  1 0/279 (0.00%)  0
Shock  1  0/283 (0.00%)  0 2/279 (0.72%)  2
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK1437173A Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   252/283 (89.05%)      146/279 (52.33%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  76/283 (26.86%)  101 29/279 (10.39%)  40
General disorders     
Chills  1  69/283 (24.38%)  89 19/279 (6.81%)  24
Fatigue  1  163/283 (57.60%)  250 102/279 (36.56%)  140
Pain  1  221/283 (78.09%)  372 46/279 (16.49%)  60
Pyrexia  1  74/283 (26.15%)  96 24/279 (8.60%)  30
Swelling  1  63/283 (22.26%)  89 2/279 (0.72%)  3
Musculoskeletal and connective tissue disorders     
Myalgia  1  123/283 (43.46%)  175 48/279 (17.20%)  60
Nervous system disorders     
Headache  1  115/283 (40.64%)  166 65/279 (23.30%)  86
Skin and subcutaneous tissue disorders     
Erythema  1  116/283 (40.99%)  165 6/279 (2.15%)  7
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767467    
Other Study ID Numbers: 116428
2012-003438-18 ( EudraCT Number )
First Submitted: January 10, 2013
First Posted: January 14, 2013
Results First Submitted: January 5, 2017
Results First Posted: May 25, 2017
Last Update Posted: June 6, 2018