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Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

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ClinicalTrials.gov Identifier: NCT01610414
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Herpes Zoster
Interventions Biological: Herpes Zoster vaccine GSK1437173A
Biological: Placebo
Enrollment 1877
Recruitment Details  
Pre-assignment Details Some of the enrolled subjects were allocated subject numbers, but were not administered all doses of study vaccine, hence they did not start the study.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule. Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Period Title: Study Start - Month 13
Started 922 924
Completed 807 795
Not Completed 115 129
Reason Not Completed
Serious Adverse Event             65             67
Adverse Event             14             14
Protocol Violation             3             1
Withdrawal by Subject             23             30
Migrated/moved from study area             2             4
Lost to Follow-up             4             6
Suspected HZ episode             1             3
Other reasons for withdrawal             3             4
Period Title: Month 13 - Month 25
Started 922 924
Completed 857 854
Not Completed 65 70
Reason Not Completed
Serious Adverse Event             35             38
Adverse Event             8             4
Withdrawal by Subject             7             8
Migrated/moved from study area             4             2
Protocol Violation             0             2
Lost to Follow-up             5             9
Other reasons for withdrawal             6             7
Period Title: After Month 25
Started 922 924
Completed 874 871
Not Completed 48 53
Reason Not Completed
Study end not reached             48             53
Arm/Group Title GSK1437173A Group Placebo Group Total
Hide Arm/Group Description Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule. Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule. Total of all reporting groups
Overall Number of Baseline Participants 922 924 1846
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 922 participants 924 participants 1846 participants
54.8  (11.7) 55.1  (11.4) 55.0  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 922 participants 924 participants 1846 participants
Female
342
  37.1%
346
  37.4%
688
  37.3%
Male
580
  62.9%
578
  62.6%
1158
  62.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 922 participants 924 participants 1846 participants
African Heritage/African American
15
   1.6%
25
   2.7%
40
   2.2%
American Indian or Alaskan Native
2
   0.2%
0
   0.0%
2
   0.1%
Asian - Central/South Asian Heritage
6
   0.7%
5
   0.5%
11
   0.6%
Asian - East Asian Heritage
83
   9.0%
91
   9.8%
174
   9.4%
Asian - Japanese Heritage
43
   4.7%
38
   4.1%
81
   4.4%
Asian - South East Asian Heritage
18
   2.0%
16
   1.7%
34
   1.8%
White - Arabic/North African Heritage
9
   1.0%
12
   1.3%
21
   1.1%
White - Caucasian/European Heritage
715
  77.5%
712
  77.1%
1427
  77.3%
Mixed Origin
31
   3.4%
25
   2.7%
56
   3.0%
1.Primary Outcome
Title Number of Subjects With Confirmed Herpes Zoster (HZ) Episode
Hide Description

A suspected case of HZ was 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 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.

A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.

Time Frame From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 870 851
Measure Type: Count of Participants
Unit of Measure: Participants
49
   5.6%
135
  15.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1437173A Group, Placebo Group
Comments Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.
Type of Statistical Test Superiority
Comments Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson method
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 68.17
Confidence Interval (2-Sided) 95%
55.56 to 77.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Duration of 'Worst' HZ-associated Pain
Hide Description Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) [=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days].
Time Frame From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis, who developed a confirmed case of HZ prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 49 135
Measure Type: Number
Unit of Measure: T (day)
892.0 6275.0
3.Secondary Outcome
Title Number of Subjects With Confirmed HZ-associated Complications
Hide Description This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.
Time Frame From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 870 851
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.3%
13
   1.5%
4.Secondary Outcome
Title Number of Subjects With Postherpetic Neuralgia (PHN)
Hide Description This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.
Time Frame From Month 0 until study end (21 months median follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 870 851
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.1%
9
   1.1%
5.Secondary Outcome
Title Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects
Hide Description Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.
Time Frame At Months 0, 1, 2, 13 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the adapted According-to-Protocol (ATP) cohort for humoral immunogenicity, which included data from the ATP cohorts for humoral immunogenicity at Months 0,1,2,13 and 25. The ATP cohort for humoral immunogenicity included all subjects from humoral immunogenicity sub-cohort in ATP cohort for analysis of immunogenicity.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 82 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-gE, Month 0 Number Analyzed 82 participants 76 participants
762.8
(568.6 to 1023.5)
555.0
(404.3 to 761.8)
Anti-gE, Month 1 Number Analyzed 78 participants 71 participants
1844.2
(1282.2 to 2652.4)
556.6
(407.3 to 760.6)
Anti-gE, Month 2 Number Analyzed 82 participants 76 participants
12753.2
(7973.0 to 20399.4)
443.8
(330.8 to 595.4)
Anti-gE, Month 13 Number Analyzed 54 participants 45 participants
3183.8
(1869.8 to 5421.2)
503.6
(307.8 to 824.1)
Anti-gE, Month 25 Number Analyzed 39 participants 28 participants
2819.0
(1387.1 to 5729.1)
527.0
(274.3 to 1012.6)
6.Secondary 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 vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 901 892
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 896 participants 890 participants
688
  76.8%
56
   6.3%
Grade 3 Pain, Dose 1 Number Analyzed 896 participants 890 participants
59
   6.6%
3
   0.3%
Any Redness, Dose 1 Number Analyzed 896 participants 890 participants
187
  20.9%
5
   0.6%
Grade 3 Redness, Dose 1 Number Analyzed 896 participants 890 participants
7
   0.8%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 896 participants 890 participants
101
  11.3%
7
   0.8%
Grade 3 Swelling, Dose 1 Number Analyzed 896 participants 890 participants
1
   0.1%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 840 participants 834 participants
638
  76.0%
45
   5.4%
Grade 3 Pain, Dose 2 Number Analyzed 840 participants 834 participants
63
   7.5%
0
   0.0%
Any Redness, Dose 2 Number Analyzed 840 participants 834 participants
231
  27.5%
4
   0.5%
Grade 3 Redness, Dose 2 Number Analyzed 840 participants 834 participants
24
   2.9%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 840 participants 834 participants
132
  15.7%
3
   0.4%
Grade 3 Swelling, Dose 2 Number Analyzed 840 participants 834 participants
12
   1.4%
0
   0.0%
Any Pain, Across doses Number Analyzed 901 participants 892 participants
756
  83.9%
83
   9.3%
Grade 3 Pain, Across doses Number Analyzed 901 participants 892 participants
99
  11.0%
3
   0.3%
Any Redness, Across doses Number Analyzed 901 participants 892 participants
301
  33.4%
9
   1.0%
Grade 3 Redness, Across doses Number Analyzed 901 participants 892 participants
28
   3.1%
0
   0.0%
Any Swelling, Across doses Number Analyzed 901 participants 892 participants
168
  18.6%
9
   1.0%
Grade 3 Swelling, Across doses Number Analyzed 901 participants 892 participants
13
   1.4%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °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 vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 901 894
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 896 participants 892 participants
356
  39.7%
282
  31.6%
Grade 3 Fatigue, Dose 1 Number Analyzed 896 participants 892 participants
30
   3.3%
16
   1.8%
Related Fatigue, Dose 1 Number Analyzed 896 participants 892 participants
124
  13.8%
55
   6.2%
Any Gastrointestinal, Dose 1 Number Analyzed 896 participants 892 participants
150
  16.7%
134
  15.0%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 896 participants 892 participants
6
   0.7%
7
   0.8%
Related Gastrointestinal, Dose 1 Number Analyzed 896 participants 892 participants
41
   4.6%
22
   2.5%
Any Headache, Dose 1 Number Analyzed 896 participants 892 participants
156
  17.4%
121
  13.6%
Grade 3 Headache, Dose 1 Number Analyzed 896 participants 892 participants
2
   0.2%
3
   0.3%
Related Headache, Dose 1 Number Analyzed 896 participants 892 participants
51
   5.7%
32
   3.6%
Any Myalgia, Dose 1 Number Analyzed 896 participants 892 participants
340
  37.9%
170
  19.1%
Grade 3 Myalgia, Dose 1 Number Analyzed 896 participants 892 participants
22
   2.5%
11
   1.2%
Related Myalgia, Dose 1 Number Analyzed 896 participants 892 participants
170
  19.0%
50
   5.6%
Any Shivering, Dose 1 Number Analyzed 896 participants 892 participants
116
  12.9%
73
   8.2%
Grade 3 Shivering, Dose 1 Number Analyzed 896 participants 892 participants
6
   0.7%
6
   0.7%
Related Shivering, Dose 1 Number Analyzed 896 participants 892 participants
56
   6.3%
27
   3.0%
Any Temperature, Dose 1 Number Analyzed 896 participants 892 participants
60
   6.7%
28
   3.1%
Grade 3 Temperature, Dose 1 Number Analyzed 896 participants 892 participants
1
   0.1%
0
   0.0%
Related Temperature, Dose 1 Number Analyzed 896 participants 892 participants
27
   3.0%
7
   0.8%
Any Fatigue, Dose 2 Number Analyzed 836 participants 835 participants
395
  47.2%
212
  25.4%
Grade 3 Fatigue, Dose 2 Number Analyzed 836 participants 835 participants
48
   5.7%
20
   2.4%
Related Fatigue, Dose 2 Number Analyzed 836 participants 835 participants
153
  18.3%
41
   4.9%
Any Gastrointestinal, Dose 2 Number Analyzed 836 participants 835 participants
142
  17.0%
98
  11.7%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 836 participants 835 participants
13
   1.6%
12
   1.4%
Related Gastrointestinal, Dose 2 Number Analyzed 836 participants 835 participants
51
   6.1%
13
   1.6%
Any Headache, Dose 2 Number Analyzed 836 participants 835 participants
232
  27.8%
88
  10.5%
Grade 3 Headache, Dose 2 Number Analyzed 836 participants 835 participants
24
   2.9%
8
   1.0%
Related Any Headache, Dose 2 Number Analyzed 836 participants 835 participants
95
  11.4%
20
   2.4%
Any Myalgia, Dose 2 Number Analyzed 836 participants 835 participants
374
  44.7%
153
  18.3%
Grade 3 Myalgia, Dose 2 Number Analyzed 836 participants 835 participants
42
   5.0%
9
   1.1%
Related Myalgia, Dose 2 Number Analyzed 836 participants 835 participants
208
  24.9%
47
   5.6%
Any Shivering, Dose 2 Number Analyzed 836 participants 835 participants
185
  22.1%
59
   7.1%
Grade 3 Shivering, Dose 2 Number Analyzed 836 participants 835 participants
29
   3.5%
1
   0.1%
Related Shivering, Dose 2 Number Analyzed 836 participants 835 participants
102
  12.2%
16
   1.9%
Any Temperature, Dose 2 Number Analyzed 836 participants 835 participants
150
  17.9%
28
   3.4%
Grade 3 Temperature, Dose 2 Number Analyzed 836 participants 835 participants
2
   0.2%
1
   0.1%
Related Temperature, Dose 2 Number Analyzed 836 participants 835 participants
8
   1.0%
8
   1.0%
Any Fatigue, Across doses Number Analyzed 901 participants 894 participants
508
  56.4%
340
  38.0%
Grade 3 Fatigue, Across doses Number Analyzed 901 participants 894 participants
66
   7.3%
31
   3.5%
Related Fatigue, Across doses Number Analyzed 901 participants 894 participants
210
  23.3%
79
   8.8%
Any Gastrointestinal, Across doses Number Analyzed 901 participants 894 participants
238
  26.4%
183
  20.5%
Grade 3 Gastrointestinal, Across doses Number Analyzed 901 participants 894 participants
18
   2.0%
17
   1.9%
Related Gastrointestinal, Across doses Number Analyzed 901 participants 894 participants
79
   8.8%
30
   3.4%
Any Headache, Across doses Number Analyzed 901 participants 894 participants
302
  33.5%
166
  18.6%
Grade 3 Headache, Across doses Number Analyzed 901 participants 894 participants
26
   2.9%
10
   1.1%
Related Headache, Across doses Number Analyzed 901 participants 894 participants
123
  13.7%
46
   5.1%
Any Myalgia, Across doses Number Analyzed 901 participants 894 participants
484
  53.7%
234
  26.2%
Grade 3 Myalgia, Across doses Number Analyzed 901 participants 894 participants
56
   6.2%
19
   2.1%
Related Myalgia, Across doses Number Analyzed 901 participants 894 participants
279
  31.0%
83
   9.3%
Any Shivering, Across doses Number Analyzed 901 participants 894 participants
237
  26.3%
115
  12.9%
Grade 3 Shivering, Across doses Number Analyzed 901 participants 894 participants
35
   3.9%
7
   0.8%
Related Shivering, Across doses Number Analyzed 901 participants 894 participants
131
  14.5%
38
   4.3%
Any Temperature, Across doses Number Analyzed 901 participants 894 participants
183
  20.3%
50
   5.6%
Grade 3 Temperature, Across doses Number Analyzed 901 participants 894 participants
3
   0.3%
1
   0.1%
Related Temperature, Across doses Number Analyzed 901 participants 894 participants
101
  11.2%
15
   1.7%
8.Secondary 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 and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 30-day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 922 924
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
360
  39.0%
353
  38.2%
Grade 3 AE(s)
60
   6.5%
47
   5.1%
Related AE(s)
31
   3.4%
23
   2.5%
9.Secondary Outcome
Title Number of Subjects With 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.
Time Frame From Month 0 up to 365 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 922 924
Measure Type: Count of Participants
Unit of Measure: Participants
Any pIMDs
13
   1.4%
8
   0.9%
Related pIMDs
3
   0.3%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects With Any Relapse
Hide Description Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.
Time Frame From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 922 924
Measure Type: Count of Participants
Unit of Measure: Participants
239
  25.9%
253
  27.4%
11.Secondary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.
Time Frame From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Overall Number of Participants Analyzed 922 924
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs, up to Month 13
263
  28.5%
241
  26.1%
Related SAEs, up to Month 13
3
   0.3%
4
   0.4%
Any SAEs, up to Study End
329
  35.7%
310
  33.5%
12.Secondary Outcome
Title Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.
Time Frame From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Enrolled Cohort.
Arm/Group Title GSK1437173A Group Placebo Group No Group
Hide Arm/Group Description:
Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Overall Number of Participants Analyzed 932 933 3
Measure Type: Count of Participants
Unit of Measure: Participants
Fatal SAEs
118
  12.7%
124
  13.3%
0
   0.0%
Related SAEs
37
   4.0%
43
   4.6%
0
   0.0%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule. Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
All-Cause Mortality
GSK1437173A Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   118/922 (12.80%)      124/924 (13.42%)    
Hide Serious Adverse Events
GSK1437173A Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   329/922 (35.68%)      310/924 (33.55%)    
Blood and lymphatic system disorders     
Agranulocytosis  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Anaemia  1  2/922 (0.22%)  2 3/924 (0.32%)  3
Autoimmune haemolytic anaemia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cytopenia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Disseminated intravascular coagulation  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Febrile neutropenia  1  14/922 (1.52%)  16 12/924 (1.30%)  13
Haemolytic anaemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Immune thrombocytopenic purpura  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Neutropenia  1  5/922 (0.54%)  5 3/924 (0.32%)  3
Normochromic normocytic anaemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pancytopenia  1  2/922 (0.22%)  2 6/924 (0.65%)  6
Thrombocytopenia  1  4/922 (0.43%)  4 4/924 (0.43%)  4
Thrombotic microangiopathy  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Acute myocardial infarction  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Atrial fibrillation  1  4/922 (0.43%)  4 1/924 (0.11%)  1
Atrial thrombosis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Bradycardia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Cardiac amyloidosis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Cardiac arrest  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Cardiac disorder  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cardiac failure  1  3/922 (0.33%)  3 2/924 (0.22%)  2
Cardiac failure congestive  1  2/922 (0.22%)  2 3/924 (0.32%)  3
Cardio-respiratory arrest  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Cardiomyopathy  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cardiopulmonary failure  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Congestive cardiomyopathy  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Coronary artery disease  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Coronary artery occlusion  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Myocardial infarction  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Pulseless electrical activity  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Supraventricular tachycardia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Ventricular dysfunction  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Ear and labyrinth disorders     
Haematotympanum  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hypoacusis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Tympanic membrane perforation  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Endocrine disorders     
Hyperparathyroidism  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Eye disorders     
Cataract  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Diplopia  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Retinal vein occlusion  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Abdominal pain upper  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Anal fissure  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Ascites  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Colitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Constipation  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Diarrhoea  1  5/922 (0.54%)  5 3/924 (0.32%)  3
Dysphagia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Enteritis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Faecaloma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Gastritis erosive  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Gastrointestinal disorder  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Gastrointestinal haemorrhage  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Gastrooesophageal reflux disease  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Haematochezia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Ileus  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Ileus paralytic  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Inguinal hernia  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Intestinal obstruction  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Intestinal perforation  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Irritable bowel syndrome  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Large intestine perforation  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Mesenteric artery thrombosis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Nausea  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Oesophageal achalasia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pancreatitis acute  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Rectal haemorrhage  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Small intestinal obstruction  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Stomatitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Umbilical hernia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Vomiting  1  1/922 (0.11%)  1 1/924 (0.11%)  1
General disorders     
Adverse drug reaction  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Asthenia  1  2/922 (0.22%)  2 2/924 (0.22%)  2
Cardiac death  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Death  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Fatigue  1  2/922 (0.22%)  2 0/924 (0.00%)  0
General physical health deterioration  1  1/922 (0.11%)  1 3/924 (0.32%)  3
Hernia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Infusion site extravasation  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Mucosal inflammation  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Multiple organ dysfunction syndrome  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Pain  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Pyrexia  1  10/922 (1.08%)  11 8/924 (0.87%)  9
Sudden death  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Systemic inflammatory response syndrome  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Hepatobiliary disorders     
Acute hepatic failure  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Bile duct obstruction  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Bile duct stone  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Cholecystitis  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Cholecystitis chronic  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cholelithiasis  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Hepatic failure  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Hepatic function abnormal  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hepatitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Hepatitis cholestatic  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Hepatitis toxic  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Portal hypertension  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Immune system disorders     
Acute graft versus host disease  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Amyloidosis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Chronic graft versus host disease  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Graft versus host disease  1  6/922 (0.65%)  6 0/924 (0.00%)  0
Graft versus host disease in gastrointestinal tract  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Graft versus host disease in liver  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Graft versus host disease in skin  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Infections and infestations     
Abscess  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Appendicitis  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Aspergillus infection  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Atypical pneumonia  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Bacteraemia  1  3/922 (0.33%)  3 3/924 (0.32%)  4
Bacterial infection  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Bronchiolitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Bronchitis  1  2/922 (0.22%)  2 6/924 (0.65%)  6
Bronchopulmonary aspergillosis  1  4/922 (0.43%)  4 2/924 (0.22%)  2
Campylobacter gastroenteritis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Catheter site infection  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cellulitis  1  0/922 (0.00%)  0 4/924 (0.43%)  4
Clostridium difficile colitis  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Cytomegalovirus infection  1  1/922 (0.11%)  1 3/924 (0.32%)  3
Device related infection  1  2/922 (0.22%)  2 3/924 (0.32%)  3
Diverticulitis  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Endophthalmitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Epididymitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Epiglottitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Epstein-barr viraemia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Erysipelas  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Escherichia sepsis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Escherichia urinary tract infection  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Febrile infection  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Fungal pharyngitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Furuncle  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Gastroenteritis  1  3/922 (0.33%)  4 2/924 (0.22%)  2
Gastroenteritis salmonella  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Gastrointestinal viral infection  1  1/922 (0.11%)  1 0/924 (0.00%)  0
H1n1 influenza  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Hepatitis b  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Hepatitis b reactivation  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Herpes simplex  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Herpes zoster  1  1/922 (0.11%)  1 5/924 (0.54%)  5
Herpes zoster cutaneous disseminated  1  1/922 (0.11%)  1 10/924 (1.08%)  10
Herpes zoster meningitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Herpes zoster meningoencephalitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Impetigo  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Infection  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Influenza  1  11/922 (1.19%)  11 7/924 (0.76%)  7
Klebsiella bacteraemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Klebsiella infection  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Lower respiratory tract infection  1  6/922 (0.65%)  6 2/924 (0.22%)  2
Lower respiratory tract infection bacterial  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Lung abscess  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Lung infection  1  0/922 (0.00%)  0 4/924 (0.43%)  4
Meningitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Meningitis meningococcal  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Meningitis pneumococcal  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Meningitis viral  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Meningoencephalitis herpetic  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Mycoplasma infection  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Myelitis  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Neutropenic sepsis  1  0/922 (0.00%)  0 3/924 (0.32%)  3
Oral candidiasis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Osteomyelitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Otitis media  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Otitis media chronic  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Parainfluenzae virus infection  1  0/922 (0.00%)  0 4/924 (0.43%)  4
Peritonitis  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Pharyngeal abscess  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pneumococcal sepsis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  3/922 (0.33%)  3 1/924 (0.11%)  1
Pneumonia  1  55/922 (5.97%)  64 41/924 (4.44%)  46
Pneumonia bacterial  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Pneumonia fungal  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Pneumonia haemophilus  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pneumonia influenzal  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Pneumonia legionella  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Pneumonia necrotising  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pneumonia parainfluenzae viral  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pneumonia pneumococcal  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Pneumonia pseudomonal  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pneumonia staphylococcal  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pneumonia viral  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Postoperative wound infection  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pyelonephritis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Respiratory syncytial virus bronchitis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Respiratory syncytial virus infection  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Respiratory tract infection  1  7/922 (0.76%)  7 10/924 (1.08%)  11
Respiratory tract infection bacterial  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Sepsis  1  15/922 (1.63%)  15 8/924 (0.87%)  9
Septic shock  1  7/922 (0.76%)  7 5/924 (0.54%)  5
Serratia sepsis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Sinusitis  1  3/922 (0.33%)  3 2/924 (0.22%)  2
Sinusitis bacterial  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Skin infection  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Spinal cord abscess  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Staphylococcal abscess  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Staphylococcal scalded skin syndrome  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Staphylococcal sepsis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Streptococcal infection  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Upper respiratory tract infection  1  4/922 (0.43%)  4 1/924 (0.11%)  1
Urinary tract infection  1  2/922 (0.22%)  2 2/924 (0.22%)  2
Urosepsis  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Viral infection  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Injury, poisoning and procedural complications     
Compression fracture  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Femoral neck fracture  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Femur fracture  1  4/922 (0.43%)  4 0/924 (0.00%)  0
Fibula fracture  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Foot fracture  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Humerus fracture  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Incisional hernia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Laceration  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pneumonitis chemical  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Spinal fracture  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Sternal fracture  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Subdural haematoma  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Subdural haemorrhage  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Toxicity to various agents  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Transfusion reaction  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Investigations     
Immunoglobulins decreased  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Liver function test abnormal  1  0/922 (0.00%)  0 1/924 (0.11%)  2
Neutrophil count decreased  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Transaminases increased  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Metabolism and nutrition disorders     
Cachexia  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Dehydration  1  2/922 (0.22%)  2 2/924 (0.22%)  2
Diabetes mellitus  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Diabetes mellitus inadequate control  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Gout  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hypercalcaemia  1  4/922 (0.43%)  4 0/924 (0.00%)  0
Hyperglycaemia  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Hypokalaemia  1  3/922 (0.33%)  3 1/924 (0.11%)  1
Metabolic acidosis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Tumour lysis syndrome  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Arthritis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Back pain  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Bone pain  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Kyphosis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Lumbar spinal stenosis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Neck pain  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Pathological fracture  1  3/922 (0.33%)  3 1/924 (0.11%)  1
Polymyalgia rheumatica  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Rotator cuff syndrome  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Systemic scleroderma  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Trigger finger  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute leukaemia  1  2/922 (0.22%)  3 1/924 (0.11%)  1
Acute myeloid leukaemia  1  6/922 (0.65%)  6 8/924 (0.87%)  8
Acute promyelocytic leukaemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Adenocarcinoma of colon  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Angiocentric lymphoma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Angioimmunoblastic t-cell lymphoma  1  0/922 (0.00%)  0 2/924 (0.22%)  2
B-cell lymphoma  1  12/922 (1.30%)  12 11/924 (1.19%)  11
Benign breast neoplasm  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Bile duct cancer  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Breast cancer  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Burkitt's lymphoma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Central nervous system lymphoma  1  5/922 (0.54%)  5 2/924 (0.22%)  2
Diffuse large b-cell lymphoma  1  13/922 (1.41%)  14 11/924 (1.19%)  11
Epstein-barr virus associated lymphoproliferative disorder  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Ewing's sarcoma metastatic  1  0/922 (0.00%)  0 1/924 (0.11%)  2
Gastric cancer  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hairy cell leukaemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hodgkin's disease  1  10/922 (1.08%)  10 3/924 (0.32%)  3
Leiomyosarcoma  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Leukaemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Lipoma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Lung adenocarcinoma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Lymphoma  1  13/922 (1.41%)  13 13/924 (1.41%)  13
Malignant melanoma  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Malignant ovarian cyst  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Mantle cell lymphoma  1  6/922 (0.65%)  6 4/924 (0.43%)  4
Marginal zone lymphoma  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Mesothelioma malignant  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Metastases to adrenals  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Metastases to central nervous system  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Metastases to meninges  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Metastatic carcinoma of the bladder  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Myeloid leukaemia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Non-hodgkin's lymphoma  1  4/922 (0.43%)  4 9/924 (0.97%)  9
Non-small cell lung cancer  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Pancreatic carcinoma  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Peripheral t-cell lymphoma unspecified  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Plasma cell leukaemia  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Plasma cell myeloma  1  90/922 (9.76%)  95 70/924 (7.58%)  71
Plasmacytoma  1  2/922 (0.22%)  3 1/924 (0.11%)  1
Precursor t-lymphoblastic lymphoma/leukaemia  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Prostate cancer  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Renal neoplasm  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Rhabdomyosarcoma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Squamous cell carcinoma  1  1/922 (0.11%)  1 0/924 (0.00%)  0
T-cell lymphoma  1  7/922 (0.76%)  7 3/924 (0.32%)  3
Testicular cancer metastatic  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Testis cancer  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Tumour pain  1  0/922 (0.00%)  0 1/924 (0.11%)  2
Nervous system disorders     
Cerebral haemorrhage  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Cerebral infarction  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Cerebral ischaemia  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Cerebral thrombosis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cerebrospinal fistula  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cerebrovascular accident  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Demyelinating polyneuropathy  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Disturbance in attention  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Dizziness  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Embolic stroke  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Epilepsy  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Facial paralysis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Generalised tonic-clonic seizure  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Guillain-barre syndrome  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Haemorrhage intracranial  1  3/922 (0.33%)  3 0/924 (0.00%)  0
Hemiparesis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Metabolic encephalopathy  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Optic neuritis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Paraplegia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Parkinsonism  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Post herpetic neuralgia  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Radicular pain  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Sciatica  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Seizure  1  1/922 (0.11%)  1 3/924 (0.32%)  3
Spinal cord compression  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Status epilepticus  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Syncope  1  3/922 (0.33%)  3 3/924 (0.32%)  3
Transient ischaemic attack  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Vith nerve paralysis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion missed  1  0/922 (0.00%)  0 1/924 (0.11%)  2
Psychiatric disorders     
Drug use disorder  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hallucination  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Mental status changes  1  1/922 (0.11%)  2 0/924 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  12/922 (1.30%)  12 4/924 (0.43%)  4
Bladder neck obstruction  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Chronic kidney disease  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Cystitis haemorrhagic  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Haematuria  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Hydronephrosis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Renal colic  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Renal failure  1  4/922 (0.43%)  4 2/924 (0.22%)  2
Renal impairment  1  3/922 (0.33%)  3 0/924 (0.00%)  0
Reproductive system and breast disorders     
Prostatitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute promyelocytic leukaemia differentiation syndrome  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Acute pulmonary oedema  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Acute respiratory distress syndrome  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Asthma  1  0/922 (0.00%)  0 3/924 (0.32%)  3
Asthmatic crisis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Cough  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Dyspnoea  1  2/922 (0.22%)  2 3/924 (0.32%)  3
Emphysema  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Haemoptysis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hiccups  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Interstitial lung disease  1  1/922 (0.11%)  1 2/924 (0.22%)  2
Lung disorder  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Organising pneumonia  1  2/922 (0.22%)  2 0/924 (0.00%)  0
Pleural effusion  1  2/922 (0.22%)  2 1/924 (0.11%)  1
Pneumonitis  1  2/922 (0.22%)  2 2/924 (0.22%)  3
Pulmonary congestion  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pulmonary embolism  1  3/922 (0.33%)  3 4/924 (0.43%)  4
Pulmonary haemorrhage  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pulmonary mass  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pulmonary oedema  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Pulmonary thrombosis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Respiratory failure  1  2/922 (0.22%)  2 3/924 (0.32%)  3
Tonsillar hypertrophy  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Skin and subcutaneous tissue disorders     
Cutaneous vasculitis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Parapsoriasis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Psoriasis  1  1/922 (0.11%)  1 0/924 (0.00%)  0
Rash  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Skin ulcer  1  0/922 (0.00%)  0 2/924 (0.22%)  2
Toxic skin eruption  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Vascular disorders     
Circulatory collapse  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Deep vein thrombosis  1  2/922 (0.22%)  2 3/924 (0.32%)  3
Haematoma  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hypertensive crisis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Hypotension  1  1/922 (0.11%)  1 1/924 (0.11%)  1
Peripheral artery thrombosis  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Shock haemorrhagic  1  0/922 (0.00%)  0 1/924 (0.11%)  1
Venous thrombosis limb  1  1/922 (0.11%)  1 0/924 (0.00%)  0
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   813/922 (88.18%)      485/924 (52.49%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  238/922 (25.81%)  293 185/924 (20.02%)  235
General disorders     
Chills  1  238/922 (25.81%)  303 117/924 (12.66%)  134
Fatigue  1  509/922 (55.21%)  754 341/924 (36.90%)  496
Pain  1  757/922 (82.10%)  1327 84/924 (9.09%)  103
Pyrexia  1  192/922 (20.82%)  224 57/924 (6.17%)  66
Swelling  1  168/922 (18.22%)  233 9/924 (0.97%)  10
Musculoskeletal and connective tissue disorders     
Myalgia  1  485/922 (52.60%)  718 236/924 (25.54%)  327
Nervous system disorders     
Headache  1  304/922 (32.97%)  391 170/924 (18.40%)  215
Skin and subcutaneous tissue disorders     
Erythema  1  304/922 (32.97%)  422 11/924 (1.19%)  11
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
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01610414    
Other Study ID Numbers: 115523
2012-000138-20 ( EudraCT Number )
First Submitted: May 31, 2012
First Posted: June 4, 2012
Results First Submitted: November 3, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018