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Trial record 1 of 2 for:    NCT02058589
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Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant

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ClinicalTrials.gov Identifier: NCT02058589
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : August 1, 2018
Last Update Posted : August 1, 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 GSK1437173A
Drug: Placebo
Enrollment 265
Recruitment Details  
Pre-assignment Details Out of 265 subjects originally enrolled in the study, only 264 subjects received vaccination and were hence included in the Total Vaccinated Cohort.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Period Title: Overall Study
Started 132 132
Completed 130 130
Not Completed 2 2
Reason Not Completed
Serious Adverse Event             1             1
Non-Serious Adverse Event             1             0
Withdrawal by Subject             0             1
Arm/Group Title GSK1437173A Group Control Group Total
Hide Arm/Group Description Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. Total of all reporting groups
Overall Number of Baseline Participants 132 132 264
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 132 participants 264 participants
52.3  (12.5) 52.4  (12.8) 52.4  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 132 participants 264 participants
Female
38
  28.8%
41
  31.1%
79
  29.9%
Male
94
  71.2%
91
  68.9%
185
  70.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 132 participants 264 participants
African Heritage / African American
3
   2.3%
1
   0.8%
4
   1.5%
Asian - Central/South Asian Heritage
1
   0.8%
2
   1.5%
3
   1.1%
Asian - East Asian Heritage
20
  15.2%
22
  16.7%
42
  15.9%
Asian - Japanese Heritage
0
   0.0%
1
   0.8%
1
   0.4%
Asian - South East Asian Heritage
10
   7.6%
3
   2.3%
13
   4.9%
White - Arabic / North African Heritage
2
   1.5%
2
   1.5%
4
   1.5%
White - Caucasian / European Heritage
88
  66.7%
97
  73.5%
185
  70.1%
Unspecified
8
   6.1%
4
   3.0%
12
   4.5%
1.Primary Outcome
Title Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity
Hide Description Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination 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 post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).
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 evaluable subjects up to Month 2, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 121 119
Measure Type: Count of Participants
Unit of Measure: Participants
97
  80.2%
5
   4.2%
2.Primary Outcome
Title Number of Subjects With 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 when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame Within 7 days (Days 0-6) after each dose and across doses.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 131 132
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 131 participants 132 participants
107
  81.7%
8
   6.1%
Grade 3 Pain, Dose 1 Number Analyzed 131 participants 132 participants
10
   7.6%
0
   0.0%
Any Redness, Dose 1 Number Analyzed 131 participants 132 participants
24
  18.3%
1
   0.8%
Grade 3 Redness, Dose 1 Number Analyzed 131 participants 132 participants
0
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 131 participants 132 participants
10
   7.6%
1
   0.8%
Grade 3 Swelling, Dose 1 Number Analyzed 131 participants 132 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 125 participants 128 participants
93
  74.4%
6
   4.7%
Grade 3 Pain, Dose 2 Number Analyzed 125 participants 128 participants
9
   7.2%
0
   0.0%
Any Redness, Dose 2 Number Analyzed 125 participants 128 participants
21
  16.8%
1
   0.8%
Grade 3 Redness, Dose 2 Number Analyzed 125 participants 128 participants
1
   0.8%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 125 participants 128 participants
11
   8.8%
0
   0.0%
Grade 3 Swelling, Dose 2 Number Analyzed 125 participants 128 participants
1
   0.8%
0
   0.0%
Any Pain, Across doses Number Analyzed 131 participants 132 participants
114
  87.0%
11
   8.3%
Grade 3 Pain, Across doses Number Analyzed 131 participants 132 participants
13
   9.9%
0
   0.0%
Any Redness, Across doses Number Analyzed 131 participants 132 participants
33
  25.2%
2
   1.5%
Grade 3 Redness, Across doses Number Analyzed 131 participants 132 participants
1
   0.8%
0
   0.0%
Any Swelling, Across doses Number Analyzed 131 participants 132 participants
15
  11.5%
1
   0.8%
Grade 3 Swelling, Across doses Number Analyzed 131 participants 132 participants
1
   0.8%
0
   0.0%
3.Primary Outcome
Title Days With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling.
Time Frame Within 7 days (Days 0-6) after each dose and overall/dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 114 11
Median (Inter-Quartile Range)
Unit of Measure: Days
Pain, Dose 1 Number Analyzed 107 participants 8 participants
3.0
(2.0 to 4.0)
1.5
(1.0 to 2.5)
Pain, Dose 2 Number Analyzed 93 participants 6 participants
3.0
(2.0 to 3.0)
1.0
(1.0 to 2.0)
Pain, Overall Number Analyzed 114 participants 11 participants
3.0
(2.0 to 4.0)
1.0
(1.0 to 2.0)
Redness, Dose 1 Number Analyzed 24 participants 1 participants
4.0
(2.5 to 6.5)
4.0
(4.0 to 4.0)
Redness, Dose 2 Number Analyzed 21 participants 1 participants
3.0
(2.0 to 7.0)
2.0
(2.0 to 2.0)
Redness, Overall Number Analyzed 33 participants 2 participants
4.0
(2.0 to 7.0)
3.0
(2.0 to 4.0)
Swelling, Dose 1 Number Analyzed 10 participants 1 participants
4.0
(2.0 to 7.0)
4.0
(4.0 to 4.0)
Swelling, Dose 2 Number Analyzed 11 participants 0 participants
4.0
(1.0 to 5.0)
Swelling, Overall Number Analyzed 15 participants 1 participants
4.0
(2.0 to 6.0)
4.0
(4.0 to 4.0)
4.Primary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.
Time Frame Within 7 days (Days 0-6) after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 131 132
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 131 participants 132 participants
47
  35.9%
42
  31.8%
Grade 3 Fatigue, Dose 1 Number Analyzed 131 participants 132 participants
3
   2.3%
3
   2.3%
Related Fatigue, Dose 1 Number Analyzed 131 participants 132 participants
8
   6.1%
2
   1.5%
Any Gastro. sympt., Dose 1 Number Analyzed 131 participants 132 participants
17
  13.0%
16
  12.1%
Grade 3 Gastro. sympt., Dose 1 Number Analyzed 131 participants 132 participants
1
   0.8%
0
   0.0%
Related Gastro. sympt., Dose 1 Number Analyzed 131 participants 132 participants
1
   0.8%
1
   0.8%
Any Headache, Dose 1 Number Analyzed 131 participants 132 participants
32
  24.4%
25
  18.9%
Grade 3 Headache, Dose 1 Number Analyzed 131 participants 132 participants
1
   0.8%
4
   3.0%
Related Headache, Dose 1 Number Analyzed 131 participants 132 participants
5
   3.8%
3
   2.3%
Any Myalgia, Dose 1 Number Analyzed 131 participants 132 participants
43
  32.8%
23
  17.4%
Grade 3 Myalgia, Dose 1 Number Analyzed 131 participants 132 participants
4
   3.1%
1
   0.8%
Related Myalgia, Dose 1 Number Analyzed 131 participants 132 participants
11
   8.4%
2
   1.5%
Any Shivering, Dose 1 Number Analyzed 131 participants 132 participants
10
   7.6%
13
   9.8%
Grade 3 Shivering, Dose 1 Number Analyzed 131 participants 132 participants
0
   0.0%
1
   0.8%
Related Shivering, Dose 1 Number Analyzed 131 participants 132 participants
3
   2.3%
2
   1.5%
Any Temperature, Dose 1 Number Analyzed 131 participants 132 participants
13
   9.9%
6
   4.5%
Grade 3 Temperature, Dose 1 Number Analyzed 131 participants 132 participants
0
   0.0%
0
   0.0%
Related Temperature, Dose 1 Number Analyzed 131 participants 132 participants
3
   2.3%
0
   0.0%
Any Fatigue, Dose 2 Number Analyzed 125 participants 128 participants
49
  39.2%
36
  28.1%
Grade 3 Fatigue, Dose 2 Number Analyzed 125 participants 128 participants
4
   3.2%
4
   3.1%
Related Fatigue, Dose 2 Number Analyzed 125 participants 128 participants
8
   6.4%
4
   3.1%
Any Gastro. sympt., Dose 2 Number Analyzed 125 participants 128 participants
14
  11.2%
14
  10.9%
Grade 3 Gastro. sympt., Dose 2 Number Analyzed 125 participants 128 participants
0
   0.0%
1
   0.8%
Related Gastro. sympt., Dose 2 Number Analyzed 125 participants 128 participants
1
   0.8%
2
   1.6%
Any Headache, Dose 2 Number Analyzed 125 participants 128 participants
35
  28.0%
22
  17.2%
Grade 3 Headache, Dose 2 Number Analyzed 125 participants 128 participants
2
   1.6%
3
   2.3%
Related Headache, Dose 2 Number Analyzed 125 participants 128 participants
9
   7.2%
1
   0.8%
Any Myalgia, Dose 2 Number Analyzed 125 participants 128 participants
47
  37.6%
19
  14.8%
Grade 3 Myalgia, Dose 2 Number Analyzed 125 participants 128 participants
8
   6.4%
3
   2.3%
Related Myalgia, Dose 2 Number Analyzed 125 participants 128 participants
14
  11.2%
3
   2.3%
Any Shivering, Dose 2 Number Analyzed 125 participants 128 participants
23
  18.4%
9
   7.0%
Grade 3 Shivering, Dose 2 Number Analyzed 125 participants 128 participants
4
   3.2%
2
   1.6%
Related Shivering, Dose 2 Number Analyzed 125 participants 128 participants
9
   7.2%
0
   0.0%
Any Temperature, Dose 2 Number Analyzed 125 participants 128 participants
21
  16.8%
7
   5.5%
Grade 3 Temperature, Dose 2 Number Analyzed 125 participants 128 participants
1
   0.8%
0
   0.0%
Related Temperature, Dose 2 Number Analyzed 125 participants 128 participants
6
   4.8%
0
   0.0%
Any Fatigue, Across doses Number Analyzed 131 participants 132 participants
62
  47.3%
53
  40.2%
Grade 3 Fatigue, Across doses Number Analyzed 131 participants 132 participants
4
   3.1%
6
   4.5%
Related Fatigue, Across doses Number Analyzed 131 participants 132 participants
15
  11.5%
4
   3.0%
Any Gastro. sympt., Across doses Number Analyzed 131 participants 132 participants
24
  18.3%
24
  18.2%
Grade 3 Gastro. sympt., Across doses Number Analyzed 131 participants 132 participants
1
   0.8%
1
   0.8%
Related Gastro. sympt.,Across doses Number Analyzed 131 participants 132 participants
2
   1.5%
3
   2.3%
Any Headache, Across doses Number Analyzed 131 participants 132 participants
44
  33.6%
34
  25.8%
Grade 3 Headache, Across doses Number Analyzed 131 participants 132 participants
2
   1.5%
5
   3.8%
Related Headache, Across doses Number Analyzed 131 participants 132 participants
12
   9.2%
4
   3.0%
Any Myalgia, Dose Across doses Number Analyzed 131 participants 132 participants
65
  49.6%
31
  23.5%
Grade 3 Myalgia, Dose Across doses Number Analyzed 131 participants 132 participants
9
   6.9%
3
   2.3%
Related Myalgia, Dose Across doses Number Analyzed 131 participants 132 participants
21
  16.0%
4
   3.0%
Any Shivering, Dose Across doses Number Analyzed 131 participants 132 participants
29
  22.1%
16
  12.1%
Grade 3 Shivering, Dose Across doses Number Analyzed 131 participants 132 participants
4
   3.1%
2
   1.5%
Related Shivering, Dose Across doses Number Analyzed 131 participants 132 participants
11
   8.4%
2
   1.5%
Any Temperature, Dose Across doses Number Analyzed 131 participants 132 participants
31
  23.7%
13
   9.8%
Grade 3 Temperature, Dose Across doses Number Analyzed 131 participants 132 participants
1
   0.8%
0
   0.0%
Related Temperature, Dose Across doses Number Analyzed 131 participants 132 participants
9
   6.9%
0
   0.0%
5.Primary Outcome
Title Days With Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Time Frame Within 7 days (Days 0-6) after each dose and overall/dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 65 53
Median (Inter-Quartile Range)
Unit of Measure: Days
Fatigue, Dose 1 Number Analyzed 47 participants 42 participants
3.0
(2.0 to 6.0)
3.0
(1.0 to 7.0)
Fatigue, Dose 2 Number Analyzed 49 participants 36 participants
3.0
(2.0 to 5.0)
4.5
(2.0 to 7.0)
Fatigue, Overall Number Analyzed 62 participants 53 participants
3.0
(2.0 to 5.5)
4.0
(2.0 to 7.0)
Gastrointestinal symptoms, Dose 1 Number Analyzed 17 participants 16 participants
2.0
(1.0 to 2.0)
3.5
(1.0 to 4.5)
Gastrointestinal symptoms, Dose 2 Number Analyzed 14 participants 14 participants
2.0
(1.0 to 2.0)
2.0
(1.0 to 3.0)
Gastrointestinal symptoms, Overall Number Analyzed 24 participants 24 participants
2.0
(1.0 to 2.0)
2.0
(1.0 to 4.0)
Headache, Dose 1 Number Analyzed 32 participants 25 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 3.0)
Headache, Dose 2 Number Analyzed 35 participants 22 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 4.0)
Headache, Overall Number Analyzed 44 participants 34 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Myalgia, Dose 1 Number Analyzed 43 participants 23 participants
3.0
(2.0 to 4.0)
3.0
(1.0 to 7.0)
Myalgia, Dose 2 Number Analyzed 47 participants 19 participants
2.0
(1.0 to 4.0)
7.0
(2.0 to 7.0)
Myalgia, Overall Number Analyzed 65 participants 31 participants
3.0
(1.0 to 4.0)
5.0
(1.0 to 7.0)
Shivering, Dose 1 Number Analyzed 10 participants 13 participants
2.0
(1.0 to 4.0)
2.0
(1.0 to 7.0)
Shivering, Dose 2 Number Analyzed 23 participants 9 participants
1.0
(1.0 to 2.0)
3.0
(2.0 to 7.0)
Shivering, Overall Number Analyzed 29 participants 16 participants
1.0
(1.0 to 2.0)
2.5
(1.0 to 7.0)
Temperature, Dose 1 Number Analyzed 13 participants 6 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
Temperature, Dose 2 Number Analyzed 21 participants 7 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
Temperature, Overall Number Analyzed 31 participants 13 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
6.Primary Outcome
Title Number of Subjects With Unsolicited Symptoms (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 subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
At least one symptom
51
  38.6%
44
  33.3%
Subjects with grade 3 AEs
7
   5.3%
5
   3.8%
Subjects with related AEs
7
   5.3%
3
   2.3%
7.Primary Outcome
Title Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Hide Description 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 (Month 0) up to 1 month post last vaccination (Month 2).
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 dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Time Frame From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
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 dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
6
   4.5%
5
   3.8%
Related SAEs
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Subjects With Renal Allograft Rejection
Hide Description Renal allograft rejection was confirmed through biopsy.
Time Frame From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
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 dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
Rejection confirmed
0
   0.0%
0
   0.0%
Rejection not confirmed
0
   0.0%
3
   2.3%
10.Primary Outcome
Title Number of Subjects With Changes in Allograft Function
Hide Description Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.
Time Frame From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on subjects with pre and post vaccination serum creatinine data available up to Month 2, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 113 107
Measure Type: Count of Participants
Unit of Measure: Participants
≥1.20 fold increase
5
   4.4%
7
   6.5%
≥1.50 fold increase
0
   0.0%
1
   0.9%
≥1.75 fold increase
0
   0.0%
1
   0.9%
≥2 fold increase
0
   0.0%
1
   0.9%
11.Secondary Outcome
Title Anti-gE Antibody Concentrations
Hide Description Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.
Time Frame At Months 0, 1, 2, 7 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 evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 121 119
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
anti-gE, Month 0 Number Analyzed 121 participants 119 participants
1354.4
(1118.3 to 1640.4)
1495.7
(1202.3 to 1860.8)
anti-gE, Month 1 Number Analyzed 121 participants 119 participants
9530.5
(7111.3 to 12772.7)
1501.9
(1231.3 to 1832.0)
anti-gE, Month 2 Number Analyzed 121 participants 119 participants
19163.8
(15041.5 to 24416.0)
1489.4
(1215.8 to 1824.7)
anti-gE, Month 7 Number Analyzed 110 participants 115 participants
13066.7
(10291.5 to 16590.4)
1533.7
(1249.6 to 1882.3)
anti-gE, Month 13 Number Analyzed 111 participants 111 participants
8545.1
(6753.7 to 10811.5)
1572.7
(1269.6 to 1948.1)
12.Secondary Outcome
Title Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity
Hide Description Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by ELISA.
Time Frame At Months 1, 7 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 evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 121 119
Measure Type: Count of Participants
Unit of Measure: Participants
anti-gE, Month 1 Number Analyzed 121 participants 119 participants
77
  63.6%
3
   2.5%
anti-gE, Month 7 Number Analyzed 110 participants 114 participants
83
  75.5%
5
   4.4%
anti-gE, Month 13 Number Analyzed 111 participants 109 participants
74
  66.7%
7
   6.4%
13.Secondary Outcome
Title Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Hide Description Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).
Time Frame At Months 0, 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 up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: gE-specific CD4+ T-cells/million T-cells
Month 0 Number Analyzed 31 participants 30 participants
110.9  (182.09) 165.75  (242.92)
Month 2 Number Analyzed 32 participants 31 participants
2433.07  (2102.29) 156.98  (274.81)
Month 13 Number Analyzed 33 participants 31 participants
1320.92  (1823.64) 129.41  (197.92)
14.Secondary Outcome
Title Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells
Hide Description Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was 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/10 million 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 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 up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 30 28
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 28 participants 28 participants
20
  71.4%
0
   0.0%
Month 13 Number Analyzed 30 participants 27 participants
17
  56.7%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects With Any and Related SAEs
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Time Frame From 1 month post last vaccination (Month 2) 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 dose of the study vaccine administered and documented.If a subject reported a SAE exactly 1 month post-last vaccination (Month 2), it is possible that he/she might have also been taken into consideration for the Day0 up to Month2 SAEs assessment
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
21
  15.9%
29
  22.0%
Related SAEs
0
   0.0%
1
   0.8%
16.Secondary Outcome
Title Number of Subjects With Any pIMDs
Hide Description 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 1 month post last vaccination (Month 2) 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 dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.0%
2
   1.5%
17.Secondary Outcome
Title Number of Subjects With Renal Allograft Rejection
Hide Description Renal allograft rejection was confirmed through biopsy.
Time Frame From 1 month post last vaccination (Month 2) 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 dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 132 132
Measure Type: Count of Participants
Unit of Measure: Participants
Rejection confirmed
4
   3.0%
7
   5.3%
Rejection not confirmed
12
   9.1%
13
   9.8%
18.Secondary Outcome
Title Number of Subjects With Changes in Allograft Function
Hide Description Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.
Time Frame From 1 month post last vaccination (Month 2) until study end (Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on subjects with pre and post vaccination serum creatinine data available from Month 2 to Month 13, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Overall Number of Participants Analyzed 130 132
Measure Type: Count of Participants
Unit of Measure: Participants
≥1.20 fold increase
17
  13.1%
22
  16.7%
≥1.50 fold increase
4
   3.1%
3
   2.3%
≥1.75 fold increase
3
   2.3%
1
   0.8%
≥2 fold increase
2
   1.5%
0
   0.0%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 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, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
All-Cause Mortality
GSK1437173A Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/132 (0.76%)      1/132 (0.76%)    
Hide Serious Adverse Events
GSK1437173A Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/132 (19.70%)      33/132 (25.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Cardiac disorders     
Atrial fibrillation  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Cardiac failure  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Coronary artery disease  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Myocardial infarction  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Ear and labyrinth disorders     
Vertigo  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Gastrointestinal disorders     
Enteritis  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Gastritis  1  1/132 (0.76%)  1 0/132 (0.00%)  0
General disorders     
Mucosal inflammation  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Hepatobiliary disorders     
Cholelithiasis  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Immune system disorders     
Kidney transplant rejection  1  1/132 (0.76%)  1 2/132 (1.52%)  2
Transplant rejection  1  2/132 (1.52%)  2 4/132 (3.03%)  4
Infections and infestations     
Abscess limb  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Atypical pneumonia  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Beta haemolytic streptococcal infection  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Clostridium colitis  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Erysipelas  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Escherichia infection  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Gastroenteritis  1  2/132 (1.52%)  2 4/132 (3.03%)  4
Helicobacter gastritis  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Herpes zoster  1  0/132 (0.00%)  0 4/132 (3.03%)  4
Influenza  1  3/132 (2.27%)  3 0/132 (0.00%)  0
Klebsiella sepsis  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Localised infection  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Meningitis  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Pneumocystis jirovecii pneumonia  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Pneumonia  1  1/132 (0.76%)  1 1/132 (0.76%)  1
Postoperative wound infection  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Pyelonephritis  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Pyelonephritis acute  1  4/132 (3.03%)  4 1/132 (0.76%)  1
Renal graft infection  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Respiratory tract infection  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Upper respiratory tract infection  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Urinary tract infection  1  2/132 (1.52%)  2 3/132 (2.27%)  4
Urosepsis  1  1/132 (0.76%)  1 1/132 (0.76%)  1
Viral infection  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Multiple fractures  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Radius fracture  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Road traffic accident  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Upper limb fracture  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Vascular graft stenosis  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Vascular graft thrombosis  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Investigations     
Blood creatinine increased  1  0/132 (0.00%)  0 3/132 (2.27%)  3
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Diabetes mellitus inadequate control  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Diabetic ketoacidosis  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Type 2 diabetes mellitus  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign gastrointestinal neoplasm  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Breast cancer  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Burkitt's lymphoma  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Squamous cell carcinoma of skin  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous incomplete  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/132 (0.00%)  0 1/132 (0.76%)  1
Renal cyst  1  1/132 (0.76%)  1 0/132 (0.00%)  0
Renal impairment  1  0/132 (0.00%)  0 1/132 (0.76%)  1
1
Term from vocabulary, MedDRA 20.1
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   121/132 (91.67%)      78/132 (59.09%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  24/132 (18.18%)  31 24/132 (18.18%)  30
General disorders     
Chills  1  29/132 (21.97%)  33 16/132 (12.12%)  22
Fatigue  1  62/132 (46.97%)  96 54/132 (40.91%)  79
Pain  1  114/132 (86.36%)  202 11/132 (8.33%)  14
Pyrexia  1  32/132 (24.24%)  37 14/132 (10.61%)  14
Swelling  1  15/132 (11.36%)  21 1/132 (0.76%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  65/132 (49.24%)  90 31/132 (23.48%)  42
Nervous system disorders     
Headache  1  44/132 (33.33%)  68 35/132 (26.52%)  48
Skin and subcutaneous tissue disorders     
Erythema  1  33/132 (25.00%)  45 2/132 (1.52%)  2
1
Term from vocabulary, MedDRA 20.1
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: NCT02058589    
Other Study ID Numbers: 116886
2012-005059-18 ( EudraCT Number )
First Submitted: February 6, 2014
First Posted: February 10, 2014
Results First Submitted: April 10, 2018
Results First Posted: August 1, 2018
Last Update Posted: August 1, 2018