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Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

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ClinicalTrials.gov Identifier: NCT01827839
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : March 7, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Herpes Zoster
Intervention Biological: Herpes Zoster vaccine (GSK1437173A)
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Period Title: Overall Study
Started 96
Completed 93
Not Completed 3
Reason Not Completed
Adverse Event             1
Consent Withdrawal             2
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Baseline Participants 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants
64.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants
Female
63
  65.6%
Male
33
  34.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants
White - Caucasian/European
92
  95.8%
Asian - Central/South Asian
2
   2.1%
Asian - Japanese
1
   1.0%
White - Arabic /North African
1
   1.0%
1.Primary Outcome
Title Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA
Hide Description

Vaccine response was defined as:

For initially seronegative subjects, antibody concentration at post-vaccination ≥ 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.

Time Frame At Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title GSK1437173A Group GSK1437173A Group 50-59 YOA GSK1437173A Group 60-69 YOA GSK1437173A Group >=70 YOA
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 82 29 28 25
Measure Type: Count of Participants
Unit of Measure: Participants
74
  90.2%
26
  89.7%
26
  92.9%
22
  88.0%
2.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame Within 7 days (Day 0-6) after each vaccine dose and across doses
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet filled in.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 95
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 94 participants
61
  64.9%
Grade 3 Pain, Dose 1 Number Analyzed 94 participants
3
   3.2%
Any Redness, Dose 1 Number Analyzed 94 participants
17
  18.1%
Grade 3 Redness, Dose 1 Number Analyzed 94 participants
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 94 participants
12
  12.8%
Grade 3 Swelling, Dose 1 Number Analyzed 94 participants
0
   0.0%
Any Pain, Dose 2 Number Analyzed 86 participants
56
  65.1%
Grade 3 Pain, Dose 2 Number Analyzed 86 participants
5
   5.8%
Any Redness, Dose 2 Number Analyzed 86 participants
22
  25.6%
Grade 3 Redness, Dose 2 Number Analyzed 86 participants
2
   2.3%
Any Swelling, Dose 2 Number Analyzed 86 participants
13
  15.1%
Grade 3 Swelling, Dose 2 Number Analyzed 86 participants
0
   0.0%
Any Pain, Across Doses Number Analyzed 95 participants
70
  73.7%
Grade 3 Pain, Across Doses Number Analyzed 95 participants
8
   8.4%
Any Redness, Across Doses Number Analyzed 95 participants
31
  32.6%
Grade 3 Redness, Across Doses Number Analyzed 95 participants
2
   2.1%
Any Swelling, Across Doses Number Analyzed 95 participants
19
  20.0%
Grade 3 Swelling, Across Doses Number Analyzed 95 participants
0
   0.0%
3.Primary Outcome
Title Number of Days With Solicited Local Symptoms
Hide Description The number of days with any local symptoms during the solicited post-vaccination period.
Time Frame Within 7 days (Day 0-6) after each vaccine dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Median (Inter-Quartile Range)
Unit of Measure: Days
Pain post-Dose 1
3.0
(2.0 to 4.0)
Pain post-Dose 2
3.0
(2.0 to 4.0)
Redness post-Dose 1
3.0
(1.0 to 4.0)
Redness post-Dose 2
2.5
(2.0 to 4.0)
Swelling post-Dose 1
3.0
(1.5 to 4.5)
Swelling post-Dose 2
2.0
(2.0 to 3.0)
4.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral 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 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame Within 7 days (Day 0-6) after each vaccine dose and across doses
Show Outcome Measure DataHide 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 with the symptoms sheet filled in.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 95
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 94 participants
37
  39.4%
Related Fatigue, Dose 1 Number Analyzed 94 participants
29
  30.9%
Grade 3 Fatigue, Dose 1 Number Analyzed 94 participants
5
   5.3%
Any Gastrointestinal, Dose 1 Number Analyzed 94 participants
14
  14.9%
Related Gastrointestinal, Dose 1 Number Analyzed 94 participants
6
   6.4%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 94 participants
1
   1.1%
Any Headache, Dose 1 Number Analyzed 94 participants
22
  23.4%
Related Headache, Dose 1 Number Analyzed 94 participants
15
  16.0%
Grade 3 Headache, Dose 1 Number Analyzed 94 participants
1
   1.1%
Any Myalgia, Dose 1 Number Analyzed 94 participants
25
  26.6%
Related Myalgia, Dose 1 Number Analyzed 94 participants
21
  22.3%
Grade 3 Myalgia, Dose 1 Number Analyzed 94 participants
5
   5.3%
Any Shivering, Dose 1 Number Analyzed 94 participants
15
  16.0%
Related Shivering, Dose 1 Number Analyzed 94 participants
14
  14.9%
Grade 3 Shivering, Dose 1 Number Analyzed 94 participants
2
   2.1%
Any Temperature/(Oral), Dose 1 Number Analyzed 94 participants
7
   7.4%
Related Temperature/(Oral), Dose 1 Number Analyzed 94 participants
6
   6.4%
Grade 3 Temperature/(Oral), Dose 1 Number Analyzed 94 participants
0
   0.0%
Any Fatigue, Dose 2 Number Analyzed 86 participants
41
  47.7%
Related Fatigue, Dose 2 Number Analyzed 86 participants
28
  32.6%
Grade 3 Fatigue, Dose 2 Number Analyzed 86 participants
6
   7.0%
Any Gastrointestinal, Dose 2 Number Analyzed 86 participants
13
  15.1%
Related Gastrointestinal, Dose 2 Number Analyzed 86 participants
6
   7.0%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 86 participants
2
   2.3%
Any Headache, Dose 2 Number Analyzed 86 participants
29
  33.7%
Related Headache, Dose 2 Number Analyzed 86 participants
20
  23.3%
Grade 3 Headache, Dose 2 Number Analyzed 86 participants
3
   3.5%
Any Myalgia, Dose 2 Number Analyzed 86 participants
27
  31.4%
Related Myalgia, Dose 2 Number Analyzed 86 participants
23
  26.7%
Grade 3 Myalgia, Dose 2 Number Analyzed 86 participants
2
   2.3%
Any Shivering, Dose 2 Number Analyzed 86 participants
25
  29.1%
Related Shivering, Dose 2 Number Analyzed 86 participants
21
  24.4%
Grade 3 Shivering, Dose 2 Number Analyzed 86 participants
5
   5.8%
Any Temperature/(Oral), Dose 2 Number Analyzed 86 participants
14
  16.3%
Related Temperature/(Oral), Dose 2 Number Analyzed 86 participants
11
  12.8%
Grade 3 Temperature/(Oral), Dose 2 Number Analyzed 86 participants
0
   0.0%
Any Fatigue, Across Doses Number Analyzed 95 participants
57
  60.0%
Related Fatigue, Across Doses Number Analyzed 95 participants
43
  45.3%
Grade 3 Fatigue, Across Doses Number Analyzed 95 participants
10
  10.5%
Any Gastrointestinal, Across Doses Number Analyzed 95 participants
23
  24.2%
Related Gastrointestinal, Across Doses Number Analyzed 95 participants
11
  11.6%
Grade 3 Gastrointestinal, Across Doses Number Analyzed 95 participants
2
   2.1%
Any Headache, Across Doses Number Analyzed 95 participants
37
  38.9%
Related Headache, Across Doses Number Analyzed 95 participants
28
  29.5%
Grade 3 Headache, Across Doses Number Analyzed 95 participants
4
   4.2%
Any Myalgia, Across Doses Number Analyzed 95 participants
35
  36.8%
Related Myalgia, Across Doses Number Analyzed 95 participants
31
  32.6%
Grade 3 Myalgia, Across Doses Number Analyzed 95 participants
6
   6.3%
Any Shivering, Across Doses Number Analyzed 95 participants
31
  32.6%
Related Shivering, Across Doses Number Analyzed 95 participants
26
  27.4%
Grade 3 Shivering, Across Doses Number Analyzed 95 participants
7
   7.4%
Any Temperature/(Oral), Across Doses Number Analyzed 95 participants
19
  20.0%
Related Temperature/(Oral), Across Doses Number Analyzed 95 participants
15
  15.8%
Grade 3 Temperature/(Oral), Across Doses Number Analyzed 95 participants
0
   0.0%
5.Primary Outcome
Title Number of Days With Solicited General Symptoms
Hide Description The number of days with general symptoms during the solicited post-vaccination period.
Time Frame Within 7 days (Day 0-6) after each vaccine dose
Show Outcome Measure DataHide 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 with results available for this assessment.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Median (Inter-Quartile Range)
Unit of Measure: Days
Fatigue post-Dose 1
2.0
(1.0 to 4.0)
Fatigue post-Dose 2
2.0
(1.0 to 3.0)
Gastrointestinal symptoms post-Dose 1
1.5
(1.0 to 3.0)
Gastrointestinal symptoms post-Dose 2
1.0
(1.0 to 2.0)
Headache post-Dose 1
2.0
(1.0 to 3.0)
Headache post-Dose 2
2.0
(1.0 to 3.0)
Myalgia post-Dose 1
3.0
(2.0 to 4.0)
Myalgia post-Dose 2
2.0
(1.0 to 3.0)
Shivering post-Dose 1
1.0
(1.0 to 2.0)
Shivering post-Dose 2
1.0
(1.0 to 2.0)
Temperature post-Dose 1
1.0
(1.0 to 1.0)
Temperature post-Dose 2
1.5
(1.0 to 2.0)
6.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within 30 days (Days 0-29) after each vaccination
Show Outcome Measure DataHide 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.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
30
  31.3%
Grade 3 AE(s)
11
  11.5%
Related AE(s)
12
  12.5%
7.Primary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From first vaccination up to 30 days post last vaccination
Show Outcome Measure DataHide 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.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.0%
8.Primary Outcome
Title Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame From first vaccination up to 30 days post last vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9.Secondary Outcome
Title Anti-gE Antibody Concentrations
Hide Description Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.
Time Frame At Month 0 and at Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title GSK1437173A Group 50-59 YOA GSK1437173A Group 60-69 YOA GSK1437173A Group >=70 YOA
Hide Arm/Group Description:
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 29 28 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-gE at Month 0
2561.4
(1531.4 to 4284.2)
2083.5
(1357.4 to 3198.0)
2600.6
(1319.4 to 5125.9)
Anti-gE at Month 3
56413.7
(43783.3 to 72687.6)
44470.8
(37373.2 to 52916.2)
42642.5
(34698.8 to 52404.9)
10.Secondary Outcome
Title Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Hide Description The cut-off value was 97 mIU/mL.
Time Frame At Month 0 and at Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title GSK1437173A Group 50-59 YOA GSK1437173A Group 60-69 YOA GSK1437173A Group >=70 YOA
Hide Arm/Group Description:
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
Overall Number of Participants Analyzed 29 28 25
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-gE at Month 0
29
 100.0%
28
 100.0%
25
 100.0%
Anti-gE at Month 3
29
 100.0%
28
 100.0%
25
 100.0%
11.Secondary Outcome
Title Number of Subjects With SAEs
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Starting after 30 days post last vaccination until study end (i.e. Month 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.1%
12.Secondary Outcome
Title Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame Starting after 30 days post last vaccination until study end (i.e. Month 14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description:
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1437173A Group
Hide Arm/Group Description Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
All-Cause Mortality
GSK1437173A Group
Affected / at Risk (%)
Total   0/96 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
GSK1437173A Group
Affected / at Risk (%) # Events
Total   3/96 (3.13%)    
Gastrointestinal disorders   
Chronic gastritis   1/96 (1.04%)  1
Duodenal ulcer perforation   1/96 (1.04%)  1
Gastrooesophageal reflux disease   1/96 (1.04%)  1
Pancreatitis   1/96 (1.04%)  1
Hepatobiliary disorders   
Cholecystitis   1/96 (1.04%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK1437173A Group
Affected / at Risk (%) # Events
Total   77/96 (80.21%)    
Gastrointestinal disorders   
Gastrointestinal disorder   23/96 (23.96%)  27
General disorders   
Chills   31/96 (32.29%)  42
Fatigue   57/96 (59.38%)  78
Pain   70/96 (72.92%)  118
Pyrexia   19/96 (19.79%)  21
Swelling   19/96 (19.79%)  25
Musculoskeletal and connective tissue disorders   
Myalgia   35/96 (36.46%)  52
Nervous system disorders   
Headache   37/96 (38.54%)  51
Skin and subcutaneous tissue disorders   
Erythema   31/96 (32.29%)  39
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01827839     History of Changes
Other Study ID Numbers: 116796
2012-003643-30 ( EudraCT Number )
First Submitted: March 28, 2013
First Posted: April 10, 2013
Results First Submitted: December 8, 2016
Results First Posted: March 7, 2017
Last Update Posted: October 18, 2018