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Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01777321
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : January 6, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Herpes Zoster
Intervention Biological: Herpes zoster vaccine GSK1437173A
Enrollment 60
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule. Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.
Period Title: Overall Study
Started 30 30
Completed 30 29
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group Total
Hide Arm/Group Description Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule. Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
61.6  (7.59) 62.2  (7.83) 61.90  (7.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
15
  50.0%
15
  50.0%
30
  50.0%
Male
15
  50.0%
15
  50.0%
30
  50.0%
1.Primary Outcome
Title Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)
Hide Description A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.
Time Frame Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
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 who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 29 29
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-gE, PRE
29
 100.0%
29
 100.0%
Anti-gE, M2
29
 100.0%
29
 100.0%
Anti-gE, M3
29
 100.0%
29
 100.0%
2.Primary Outcome
Title Anti-gE Antibody Concentrations
Hide Description Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Time Frame Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)
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 who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 29 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-gE, PRE
1424.3
(1042.6 to 1945.6)
1116.8
(774.5 to 1610.3)
Anti-gE, M2
19902.5
(14846.9 to 26679.6)
12842
(8558.4 to 19269.7)
Anti-gE, M3
44126.1
(36326.1 to 53601)
45521.5
(37549.5 to 55185.9)
3.Primary Outcome
Title Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
Hide Description Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time Frame At two months after Dose 1 (M2) and one month after Dose 2 (M3)
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 who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 29 29
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-gE, M2
28
  96.6%
25
  86.2%
Anti-gE, M3
29
 100.0%
29
 100.0%
4.Primary Outcome
Title Descriptive Statistics of Anti-gE Antibody Concentrations
Hide Description Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.
Time Frame Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)
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 who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 29 29
Median (Standard Deviation)
Unit of Measure: mIU/mL
Anti-gE, PRE 1404.1  (1398.82) 946.3  (3231.78)
Anti-gE, M2 19400.1  (24456.86) 14330.1  (14548.75)
Anti-gE, M3 44182  (27990.99) 42444.8  (27555.21)
5.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.
Time Frame During the 7 day (Days 0-6) post vaccination, after each dose (D) 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 who had their symptom sheet filled-in.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arm movement impairment, D1 Number Analyzed 30 participants 30 participants
10
  33.3%
7
  23.3%
Any Arm movement impairment, D2 Number Analyzed 30 participants 29 participants
16
  53.3%
11
  37.9%
Any Arm movement impairment, Across Number Analyzed 30 participants 30 participants
18
  60.0%
12
  40.0%
Grade 3 Arm movement impairment, D1 Number Analyzed 30 participants 30 participants
1
   3.3%
0
   0.0%
Grade 3 Arm movement impairment, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
0
   0.0%
Grade 3 Arm movement impairment, Across Number Analyzed 30 participants 30 participants
1
   3.3%
0
   0.0%
Any Injection site pruritus, D1 Number Analyzed 30 participants 30 participants
19
  63.3%
6
  20.0%
Any Injection site pruritus, D2 Number Analyzed 30 participants 29 participants
15
  50.0%
8
  27.6%
Any Injection site pruritus, Across Number Analyzed 30 participants 30 participants
21
  70.0%
10
  33.3%
Grade 3 Injection site pruritus, D1 Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Grade 3 Injection site pruritus, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
0
   0.0%
Grade 3 Injection site pruritus, Across Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Any Pain, D1 Number Analyzed 30 participants 30 participants
28
  93.3%
26
  86.7%
Any Pain, D2 Number Analyzed 30 participants 29 participants
25
  83.3%
21
  72.4%
Any Pain, Across Number Analyzed 30 participants 30 participants
28
  93.3%
27
  90.0%
Grade 3 Pain, D1 Number Analyzed 30 participants 30 participants
2
   6.7%
0
   0.0%
Grade 3 Pain, D2 Number Analyzed 30 participants 29 participants
1
   3.3%
0
   0.0%
Grade 3 Pain, Across Number Analyzed 30 participants 30 participants
2
   6.7%
0
   0.0%
Any Redness, D1 Number Analyzed 30 participants 30 participants
23
  76.7%
11
  36.7%
Any Redness, D2 Number Analyzed 30 participants 29 participants
23
  76.7%
12
  41.4%
Any Redness, Across Number Analyzed 30 participants 30 participants
26
  86.7%
15
  50.0%
Grade 3 Redness, D1 Number Analyzed 30 participants 30 participants
12
  40.0%
1
   3.3%
Grade 3 Redness, D2 Number Analyzed 30 participants 29 participants
12
  40.0%
1
   3.4%
Grade 3 Redness, Across Number Analyzed 30 participants 30 participants
17
  56.7%
2
   6.7%
Any Swelling, D1 Number Analyzed 30 participants 30 participants
22
  73.3%
7
  23.3%
Any Swelling, D2 Number Analyzed 30 participants 29 participants
20
  66.7%
11
  37.9%
Any Swelling, Across Number Analyzed 30 participants 30 participants
24
  80.0%
12
  40.0%
Grade 3 Swelling, D1 Number Analyzed 30 participants 30 participants
8
  26.7%
1
   3.3%
Grade 3 Swelling, D2 Number Analyzed 30 participants 29 participants
6
  20.0%
1
   3.4%
Grade 3 Swelling, Across Number Analyzed 30 participants 30 participants
10
  33.3%
2
   6.7%
6.Primary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.
Time Frame During the 7 day (Days 0-6) post vaccination, after each dose (D) 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 who had their symptom sheet filled-in.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, D1 Number Analyzed 30 participants 30 participants
14
  46.7%
12
  40.0%
Any Fatigue, D2 Number Analyzed 30 participants 29 participants
16
  53.3%
9
  31.0%
Any Fatigue, Across Number Analyzed 30 participants 30 participants
21
  70.0%
16
  53.3%
Grade 3 Fatigue, D1 Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Grade 3 Fatigue, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
1
   3.4%
Grade 3 Fatigue, Across Number Analyzed 30 participants 30 participants
0
   0.0%
1
   3.3%
Related Fatigue, D1 Number Analyzed 30 participants 30 participants
14
  46.7%
12
  40.0%
Related Fatigue, D2 Number Analyzed 30 participants 29 participants
16
  53.3%
9
  31.0%
Related Fatigue, Across Number Analyzed 30 participants 30 participants
21
  70.0%
16
  53.3%
Any Fever/Axillary, D1 Number Analyzed 30 participants 30 participants
3
  10.0%
2
   6.7%
Any Fever/Axillary, D2 Number Analyzed 30 participants 29 participants
5
  16.7%
6
  20.7%
Any Fever/Axillary, Across Number Analyzed 30 participants 30 participants
6
  20.0%
7
  23.3%
Grade 3 Fever/Axillary, D1 Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Grade 3 Fever/Axillary, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
0
   0.0%
Grade 3 Fever/Axillary, Across Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Related Fever/Axillary, D1 Number Analyzed 30 participants 30 participants
3
  10.0%
2
   6.7%
Related Fever/Axillary, D2 Number Analyzed 30 participants 29 participants
5
  16.7%
6
  20.7%
Related Fever/Axillary, Across Number Analyzed 30 participants 30 participants
6
  20.0%
7
  23.3%
Any Gastrointestinal symptoms, D1 Number Analyzed 30 participants 30 participants
2
   6.7%
4
  13.3%
Any Gastrointestinal symptoms, D2 Number Analyzed 30 participants 29 participants
5
  16.7%
3
  10.3%
Any Gastrointestinal symptoms, Across Number Analyzed 30 participants 30 participants
7
  23.3%
5
  16.7%
Grade 3 Gastrointestinal symptoms, D1 Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Grade 3 Gastrointestinal symptoms, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
1
   3.4%
Grade 3 Gastrointestinal symptoms,Across Number Analyzed 30 participants 30 participants
0
   0.0%
1
   3.3%
Related Gastrointestinal symptoms, D1 Number Analyzed 30 participants 30 participants
2
   6.7%
4
  13.3%
Related Gastrointestinal symptoms, D2 Number Analyzed 30 participants 29 participants
5
  16.7%
3
  10.3%
Related Gastrointestinal symptoms,Across Number Analyzed 30 participants 30 participants
7
  23.3%
5
  16.7%
Any Headache, D1 Number Analyzed 30 participants 30 participants
11
  36.7%
8
  26.7%
Any Headache, D2 Number Analyzed 30 participants 29 participants
11
  36.7%
10
  34.5%
Any Headache, Across Number Analyzed 30 participants 30 participants
17
  56.7%
13
  43.3%
Grade 3 Headache, D1 Number Analyzed 30 participants 30 participants
0
   0.0%
0
   0.0%
Grade 3 Headache, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
2
   6.9%
Grade 3 Headache, Across Number Analyzed 30 participants 30 participants
0
   0.0%
2
   6.7%
Related Headache, D1 Number Analyzed 30 participants 30 participants
11
  36.7%
8
  26.7%
Related Headache, D2 Number Analyzed 30 participants 29 participants
11
  36.7%
10
  34.5%
Related Headache, Across Number Analyzed 30 participants 30 participants
17
  56.7%
13
  43.3%
Any Myalgia, D1 Number Analyzed 30 participants 30 participants
2
   6.7%
1
   3.3%
Any Myalgia, D2 Number Analyzed 30 participants 29 participants
5
  16.7%
3
  10.3%
Any Myalgia, Across Number Analyzed 30 participants 30 participants
7
  23.3%
4
  13.3%
Grade 3 Myalgia, D1 Number Analyzed 30 participants 30 participants
1
   3.3%
0
   0.0%
Grade 3 Myalgia, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
1
   3.4%
Grade 3 Myalgia, Across Number Analyzed 30 participants 30 participants
1
   3.3%
1
   3.3%
Related Myalgia, D1 Number Analyzed 30 participants 30 participants
2
   6.7%
1
   3.3%
Related Myalgia, D2 Number Analyzed 30 participants 29 participants
5
  16.7%
3
  10.3%
Related Myalgia, Across Number Analyzed 30 participants 30 participants
7
  23.3%
4
  13.3%
Any Shivering, D1 Number Analyzed 30 participants 30 participants
3
  10.0%
3
  10.0%
Any Shivering, D2 Number Analyzed 30 participants 29 participants
6
  20.0%
6
  20.7%
Any Shivering, Across Number Analyzed 30 participants 30 participants
8
  26.7%
7
  23.3%
Grade 3 Shivering, D1 Number Analyzed 30 participants 30 participants
0
   0.0%
1
   3.3%
Grade 3 Shivering, D2 Number Analyzed 30 participants 29 participants
0
   0.0%
0
   0.0%
Grade 3 Shivering, Across Number Analyzed 30 participants 30 participants
0
   0.0%
1
   3.3%
Related Shivering, D1 Number Analyzed 30 participants 30 participants
3
  10.0%
3
  10.0%
Related Shivering, D2 Number Analyzed 30 participants 29 participants
6
  20.0%
6
  20.7%
Related Shivering, Across Number Analyzed 30 participants 30 participants
8
  26.7%
7
  23.3%
7.Primary Outcome
Title Mean Number of Days With Local Symptoms
Hide Description Days with solicited local symptoms were tabulated for the total vaccinated cohort.
Time Frame During the 7 day (Days 0-6) post vaccination, after each dose (D)
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Mean (Inter-Quartile Range)
Unit of Measure: Days
Days with arm movement, D1
3.9
(2 to 7)
3
(2 to 3)
Days with pain, D1
3.3
(2 to 4)
2.7
(2 to 3)
Days with injection site pruritus, D1
5.2
(2 to 7)
2.2
(1 to 3)
Days with redness, D1
6.5
(4 to 8)
2.6
(2 to 3)
Days with swelling, D1
5
(3 to 6)
3
(2 to 3)
Days with arm movement, D2
2.9
(2 to 3)
2.2
(2 to 3)
Days with pain, D2
3.4
(2 to 4)
2.3
(1 to 3)
Days with injection site pruritus, D2
4.9
(3 to 5)
1.9
(1.5 to 2)
Days with redness, D2
5.9
(3 to 6)
3.7
(3 to 4)
Days with swelling, D2
4.3
(3 to 6)
2.8
(2 to 4)
8.Primary Outcome
Title Mean Number of Days With General Symptoms
Hide Description Days with solicited general symptoms were tabulated for the total vaccinated cohort.
Time Frame During the 7 day (Days 0-6) post vaccination, after each dose (D)
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Mean (Inter-Quartile Range)
Unit of Measure: Days
Days with fatigue, D1
2.3
(1 to 3)
2
(1 to 2)
Days with fever, D1
1.3
(1 to 2)
1
(1 to 1)
Days with gastrointestinal symptoms, D1
2
(1 to 3)
2
(2 to 2)
Days with headache, D1
1.8
(1 to 2)
1.4
(1 to 2)
Days with myalgia, D1
6.5
(3 to 10)
2
(2 to 2)
Days with Shivering, D1
1.3
(1 to 2)
1.3
(1 to 2)
Days with fatigue, D2
2
(1 to 2)
1.3
(1 to 2)
Days with fever, D2
1
(1 to 1)
1
(1 to 1)
Days with gastrointestinal symptoms, D2
3.6
(2 to 5)
1.3
(1 to 2)
Days with headache, D2
2
(1 to 2)
1.3
(1 to 2)
Days with myalgia, D2
2
(1 to 2)
1.3
(1 to 2)
Days with Shivering, D2
2.2
(1 to 2.2)
1
(1 to 1)
9.Primary Outcome
Title Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) were 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 to Month 3
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Subjects With 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) post vaccination period
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
9
  30.0%
6
  20.0%
Grade 3 AEs
1
   3.3%
0
   0.0%
Related AEs
1
   3.3%
1
   3.3%
11.Primary Outcome
Title Number of Subjects With 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 Month 0 to Month 3
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.3%
0
   0.0%
12.Secondary Outcome
Title Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL
Hide Description A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL.
Time Frame At Month 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 28
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
28
 100.0%
13.Secondary Outcome
Title Anti-gE Antibody Concentrations
Hide Description Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL.
Time Frame At Month 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
15250.9
(12464 to 18660.9)
13870.2
(10184.2 to 18890.3)
14.Secondary Outcome
Title Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations
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 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time Frame Twelve Months after Dose 2 (M14)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 28
Measure Type: Count of Participants
Unit of Measure: Participants
25
  83.3%
25
  89.3%
15.Secondary Outcome
Title Number of Subjects With pIMDs
Hide Description Potential immune-mediated diseases (pIMDs) were 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 Up to Month 14 post vaccination period
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.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 Up to Month 14 post vaccination period
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 SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description:
Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.7%
1
   3.3%
Time Frame Solicited symptoms: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: up to Month 14 post vaccination.
Adverse Event Reporting Description No unsolicited AEs with a frequency over 5% were reported.
 
Arm/Group Title SC GSK1437173A Group IM GSK1437173A Group
Hide Arm/Group Description Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule. Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
All-Cause Mortality
SC GSK1437173A Group IM GSK1437173A Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
SC GSK1437173A Group IM GSK1437173A Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      1/30 (3.33%)    
Injury, poisoning and procedural complications     
Spinal compression fracture  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders     
Mallet finger  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/30 (3.33%)  1 0/30 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
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%
SC GSK1437173A Group IM GSK1437173A Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/30 (100.00%)      28/30 (93.33%)    
General disorders     
Arm movement  1  18/30 (60.00%)  18 12/30 (40.00%)  12
Injection site pruritus  1  21/30 (70.00%)  21 10/30 (33.33%)  10
Pain  1  28/30 (93.33%)  28 27/30 (90.00%)  27
Redness  1  26/30 (86.67%)  26 15/30 (50.00%)  15
Swelling  1  24/30 (80.00%)  24 12/30 (40.00%)  12
Fatigue  1  21/30 (70.00%)  21 16/30 (53.33%)  16
Fever/(Axillary)  1  6/30 (20.00%)  6 7/30 (23.33%)  7
Gastrointestinal symptoms  1  7/30 (23.33%)  7 5/30 (16.67%)  5
Headache  1  17/30 (56.67%)  17 13/30 (43.33%)  13
Myalgia (muscle aches)  1  7/30 (23.33%)  7 4/30 (13.33%)  4
Shivering  1  8/30 (26.67%)  8 7/30 (23.33%)  7
1
Term from vocabulary, MedDRA 18.0
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01777321     History of Changes
Other Study ID Numbers: 116760
2012-005671-14 ( EudraCT Number )
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: November 8, 2016
Results First Posted: January 6, 2017
Last Update Posted: October 25, 2018