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Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects

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: NCT01165203
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : June 7, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Herpes Zoster
Interventions Biological: Herpes Zoster Vaccine GSK1437173A
Biological: Placebo
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Period Title: Active Phase
Started 74 49
Completed 69 47
Not Completed 5 2
Reason Not Completed
Serious Adverse Event             1             0
Withdrawal by Subject             2             1
Migrated/moved from study area             0             1
Lost to Follow-up             2             0
Period Title: Extended Safety Follow-up Phase
Started 74 49
Completed 67 45
Not Completed 7 4
Reason Not Completed
Serious Adverse Event             1             0
Withdrawal by Subject             2             2
Migrated/moved from study area             2             1
Lost to Follow-up             2             0
Other-subjects business reasons             0             1
Arm/Group Title GSK1437173A Group Placebo Group Total
Hide Arm/Group Description Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 74 49 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 49 participants 123 participants
46.6  (10.68) 45.1  (11.36) 46.0  (10.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 49 participants 123 participants
Female
5
   6.8%
2
   4.1%
7
   5.7%
Male
69
  93.2%
47
  95.9%
116
  94.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 49 participants 123 participants
African heritage/African American
6
   8.1%
2
   4.1%
8
   6.5%
Asian-East Asian heritage
0
   0.0%
1
   2.0%
1
   0.8%
Asian-Japanese heritage
1
   1.4%
0
   0.0%
1
   0.8%
White-Caucasian/European heritage
66
  89.2%
42
  85.7%
108
  87.8%
Unspecified
1
   1.4%
4
   8.2%
5
   4.1%
1.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 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
6
   8.1%
2
   4.1%
2.Primary Outcome
Title Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
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 screening (up to 21 days prior to Month 0) until Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Any Fatal 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 screening (up to 21 days prior to Month 0) until Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects With Any Adverse Events (AEs) of Specific Interest
Hide Description AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.
Time Frame From Month 0 until Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their 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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 73 48
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 72 participants 48 participants
69
  95.8%
4
   8.3%
Grade 3 Pain, Dose 1 Number Analyzed 72 participants 48 participants
4
   5.6%
0
   0.0%
Any Redness, Dose 1 Number Analyzed 72 participants 48 participants
17
  23.6%
0
   0.0%
Grade 3 Redness, Dose 1 Number Analyzed 72 participants 48 participants
2
   2.8%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 72 participants 48 participants
12
  16.7%
0
   0.0%
Grade 3 Swelling, Dose 1 Number Analyzed 72 participants 48 participants
1
   1.4%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 66 participants 44 participants
57
  86.4%
3
   6.8%
Grade 3 Pain, Dose 2 Number Analyzed 66 participants 44 participants
8
  12.1%
0
   0.0%
Any Redness, Dose 2 Number Analyzed 66 participants 44 participants
19
  28.8%
0
   0.0%
Grade 3 Redness, Dose 2 Number Analyzed 66 participants 44 participants
1
   1.5%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 66 participants 44 participants
11
  16.7%
0
   0.0%
Grade 3 Swelling, Dose 2 Number Analyzed 66 participants 44 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 3 Number Analyzed 53 participants 38 participants
43
  81.1%
1
   2.6%
Grade 3 Pain, Dose 3 Number Analyzed 53 participants 38 participants
7
  13.2%
0
   0.0%
Any Redness, Dose 3 Number Analyzed 53 participants 38 participants
9
  17.0%
0
   0.0%
Grade 3 Redness, Dose 3 Number Analyzed 53 participants 38 participants
2
   3.8%
0
   0.0%
Any Swelling, Dose 3 Number Analyzed 53 participants 38 participants
5
   9.4%
0
   0.0%
Grade 3 Swelling, Dose 3 Number Analyzed 53 participants 38 participants
0
   0.0%
0
   0.0%
Any Pain, Across doses Number Analyzed 73 participants 48 participants
72
  98.6%
6
  12.5%
Grade 3 Pain, Across doses Number Analyzed 73 participants 48 participants
12
  16.4%
0
   0.0%
Any Redness, Across doses Number Analyzed 73 participants 48 participants
28
  38.4%
0
   0.0%
Grade 3 Redness, Across doses Number Analyzed 73 participants 48 participants
4
   5.5%
0
   0.0%
Any Swelling, Across doses Number Analyzed 73 participants 48 participants
20
  27.4%
0
   0.0%
Grade 3 Swelling, Across doses Number Analyzed 73 participants 48 participants
1
   1.4%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 73 48
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 72 participants 48 participants
30
  41.7%
13
  27.1%
Grade 3 Fatigue, Dose 1 Number Analyzed 72 participants 48 participants
0
   0.0%
3
   6.3%
Related Fatigue, Dose 1 Number Analyzed 72 participants 48 participants
17
  23.6%
8
  16.7%
Any Gastrointestinal, Dose 1 Number Analyzed 72 participants 48 participants
13
  18.1%
8
  16.7%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 72 participants 48 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 1 Number Analyzed 72 participants 48 participants
6
   8.3%
6
  12.5%
Any Headache, Dose 1 Number Analyzed 72 participants 48 participants
25
  34.7%
10
  20.8%
Grade 3 Headache, Dose 1 Number Analyzed 72 participants 48 participants
0
   0.0%
1
   2.1%
Related Headache, Dose 1 Number Analyzed 72 participants 48 participants
16
  22.2%
6
  12.5%
Any Myalgia, Dose 1 Number Analyzed 72 participants 48 participants
34
  47.2%
6
  12.5%
Grade 3 Myalgia, Dose 1 Number Analyzed 72 participants 48 participants
4
   5.6%
0
   0.0%
Related Myalgia, Dose 1 Number Analyzed 72 participants 48 participants
26
  36.1%
6
  12.5%
Any Shivering, Dose 1 Number Analyzed 72 participants 48 participants
19
  26.4%
5
  10.4%
Grade 3 Shivering, Dose 1 Number Analyzed 72 participants 48 participants
0
   0.0%
0
   0.0%
Related Shivering, Dose 1 Number Analyzed 72 participants 48 participants
11
  15.3%
5
  10.4%
Any Temperature, Dose 1 Number Analyzed 72 participants 48 participants
7
   9.7%
2
   4.2%
Grade 3 Temperature, Dose 1 Number Analyzed 72 participants 48 participants
0
   0.0%
0
   0.0%
Related Temperature, Dose 1 Number Analyzed 72 participants 48 participants
2
   2.8%
2
   4.2%
Any Fatigue, Dose 2 Number Analyzed 66 participants 44 participants
41
  62.1%
8
  18.2%
Grade 3 Fatigue, Dose 2 Number Analyzed 66 participants 44 participants
7
  10.6%
3
   6.8%
Related Fatigue, Dose 2 Number Analyzed 66 participants 44 participants
25
  37.9%
5
  11.4%
Any Gastrointestinal, Dose 2 Number Analyzed 66 participants 44 participants
18
  27.3%
3
   6.8%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 66 participants 44 participants
1
   1.5%
1
   2.3%
Related Gastrointestinal, Dose 2 Number Analyzed 66 participants 44 participants
8
  12.1%
1
   2.3%
Any Headache, Dose 2 Number Analyzed 66 participants 44 participants
32
  48.5%
3
   6.8%
Grade 3 Headache, Dose 2 Number Analyzed 66 participants 44 participants
3
   4.5%
0
   0.0%
Related Headache, Dose 2 Number Analyzed 66 participants 44 participants
18
  27.3%
1
   2.3%
Any Myalgia, Dose 2 Number Analyzed 66 participants 44 participants
33
  50.0%
4
   9.1%
Grade 3 Myalgia, Dose 2 Number Analyzed 66 participants 44 participants
1
   1.5%
1
   2.3%
Related Myalgia, Dose 2 Number Analyzed 66 participants 44 participants
24
  36.4%
2
   4.5%
Any Shivering, Dose 2 Number Analyzed 66 participants 44 participants
23
  34.8%
1
   2.3%
Grade 3 Shivering, Dose 2 Number Analyzed 66 participants 44 participants
4
   6.1%
0
   0.0%
Related Shivering, Dose 2 Number Analyzed 66 participants 44 participants
17
  25.8%
1
   2.3%
Any Temperature, Dose 2 Number Analyzed 66 participants 44 participants
12
  18.2%
1
   2.3%
Grade 3 Temperature, Dose 2 Number Analyzed 66 participants 44 participants
0
   0.0%
0
   0.0%
Related Temperature, Dose 2 Number Analyzed 66 participants 44 participants
10
  15.2%
0
   0.0%
Any Fatigue, Dose 3 Number Analyzed 53 participants 38 participants
36
  67.9%
6
  15.8%
Grade 3 Fatigue, Dose 3 Number Analyzed 53 participants 38 participants
7
  13.2%
1
   2.6%
Related Fatigue, Dose 3 Number Analyzed 53 participants 38 participants
24
  45.3%
3
   7.9%
Any Gastrointestinal, Dose 3 Number Analyzed 53 participants 38 participants
8
  15.1%
4
  10.5%
Grade 3 Gastrointestinal, Dose 3 Number Analyzed 53 participants 38 participants
1
   1.9%
0
   0.0%
Related Gastrointestinal, Dose 3 Number Analyzed 53 participants 38 participants
5
   9.4%
2
   5.3%
Any Headache, Dose 3 Number Analyzed 53 participants 38 participants
33
  62.3%
7
  18.4%
Grade 3 Headache, Dose 3 Number Analyzed 53 participants 38 participants
4
   7.5%
1
   2.6%
Related Headache, Dose 3 Number Analyzed 53 participants 38 participants
21
  39.6%
3
   7.9%
Any Myalgia, Dose 3 Number Analyzed 53 participants 38 participants
32
  60.4%
1
   2.6%
Grade 3 Myalgia, Dose 3 Number Analyzed 53 participants 38 participants
6
  11.3%
0
   0.0%
Related Myalgia, Dose 3 Number Analyzed 53 participants 38 participants
22
  41.5%
1
   2.6%
Any Shivering, Dose 3 Number Analyzed 53 participants 38 participants
20
  37.7%
1
   2.6%
Grade 3 Shivering, Dose 3 Number Analyzed 53 participants 38 participants
7
  13.2%
0
   0.0%
Related Shivering, Dose 3 Number Analyzed 53 participants 38 participants
14
  26.4%
1
   2.6%
Any Temperature, Dose 3 Number Analyzed 53 participants 38 participants
11
  20.8%
1
   2.6%
Grade 3 Temperature, Dose 3 Number Analyzed 53 participants 38 participants
0
   0.0%
0
   0.0%
Related Temperature, Dose 3 Number Analyzed 53 participants 38 participants
6
  11.3%
0
   0.0%
Any Fatigue, Across doses Number Analyzed 73 participants 48 participants
55
  75.3%
14
  29.2%
Grade 3 Fatigue, Across doses Number Analyzed 73 participants 48 participants
12
  16.4%
4
   8.3%
Related Fatigue, Across doses Number Analyzed 73 participants 48 participants
41
  56.2%
8
  16.7%
Any Gastrointestinal, Across doses Number Analyzed 73 participants 48 participants
28
  38.4%
11
  22.9%
Grade 3 Gastrointestinal, Across doses Number Analyzed 73 participants 48 participants
2
   2.7%
1
   2.1%
Related Gastrointestinal, Across doses Number Analyzed 73 participants 48 participants
16
  21.9%
7
  14.6%
Any Headache, Across doses Number Analyzed 73 participants 48 participants
47
  64.4%
15
  31.3%
Grade 3 Headache, Across doses Number Analyzed 73 participants 48 participants
6
   8.2%
2
   4.2%
Related Headache, Across doses Number Analyzed 73 participants 48 participants
34
  46.6%
8
  16.7%
Any Myalgia, Across doses Number Analyzed 73 participants 48 participants
54
  74.0%
9
  18.8%
Grade 3 Myalgia, Across doses Number Analyzed 73 participants 48 participants
10
  13.7%
1
   2.1%
Related Myalgia, Across doses Number Analyzed 73 participants 48 participants
44
  60.3%
8
  16.7%
Any Shivering, Across doses Number Analyzed 73 participants 48 participants
37
  50.7%
5
  10.4%
Grade 3 Shivering, Across doses Number Analyzed 73 participants 48 participants
11
  15.1%
0
   0.0%
Related Shivering, Across doses Number Analyzed 73 participants 48 participants
29
  39.7%
5
  10.4%
Any Temperature, Across doses Number Analyzed 73 participants 48 participants
22
  30.1%
3
   6.3%
Grade 3 Temperature, Across doses Number Analyzed 73 participants 48 participants
0
   0.0%
0
   0.0%
Related Temperature, Across doses Number Analyzed 73 participants 48 participants
17
  23.3%
2
   4.2%
7.Primary Outcome
Title Number of Subjects With Unsolicited 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
41
  55.4%
26
  53.1%
Grade 3 AE(s)
4
   5.4%
2
   4.1%
Related AE(s)
11
  14.9%
3
   6.1%
8.Primary Outcome
Title Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Hide Description The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time Frame At Screening Visit (up to 21 days prior to Month 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
70
  94.6%
41
  83.7%
Above
4
   5.4%
8
  16.3%
Albumin Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
72
  97.3%
47
  95.9%
Above
2
   2.7%
2
   4.1%
Alkaline Phosphatase Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
70
  94.6%
44
  89.8%
Above
4
   5.4%
5
  10.2%
Aspartate Aminotransferase Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
69
  93.2%
45
  91.8%
Above
5
   6.8%
4
   8.2%
Basophils Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
74
 100.0%
49
 100.0%
Above
0
   0.0%
0
   0.0%
White Blood Cells Unknown
1
   1.4%
0
   0.0%
Below
3
   4.1%
0
   0.0%
Within
69
  93.2%
47
  95.9%
Above
1
   1.4%
2
   4.1%
Total Bilirubin Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
65
  87.8%
46
  93.9%
Above
9
  12.2%
3
   6.1%
Bilirubin Conjugated / Direct Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
73
  98.6%
49
 100.0%
Above
1
   1.4%
0
   0.0%
Creatinine Unknown
0
   0.0%
0
   0.0%
Below
6
   8.1%
8
  16.3%
Within
68
  91.9%
40
  81.6%
Above
0
   0.0%
1
   2.0%
Eosinophils Unknown
0
   0.0%
0
   0.0%
Below
14
  18.9%
10
  20.4%
Within
59
  79.7%
38
  77.6%
Above
1
   1.4%
1
   2.0%
Glucose Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
1
   2.0%
Within
69
  93.2%
43
  87.8%
Above
5
   6.8%
5
  10.2%
Bicarbonate Unknown
0
   0.0%
0
   0.0%
Below
5
   6.8%
2
   4.1%
Within
69
  93.2%
47
  95.9%
Above
0
   0.0%
0
   0.0%
Haemoglobin Unknown
0
   0.0%
0
   0.0%
Below
13
  17.6%
5
  10.2%
Within
58
  78.4%
42
  85.7%
Above
3
   4.1%
2
   4.1%
Potassium Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
74
 100.0%
49
 100.0%
Above
0
   0.0%
0
   0.0%
Lymphocytes Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
1
   2.0%
Within
74
 100.0%
48
  98.0%
Above
0
   0.0%
0
   0.0%
Monocytes Unknown
0
   0.0%
0
   0.0%
Below
2
   2.7%
4
   8.2%
Within
71
  95.9%
45
  91.8%
Above
1
   1.4%
0
   0.0%
Sodium Unknown
0
   0.0%
0
   0.0%
Below
1
   1.4%
0
   0.0%
Within
73
  98.6%
49
 100.0%
Above
0
   0.0%
0
   0.0%
Neutrophils Unknown
0
   0.0%
0
   0.0%
Below
5
   6.8%
3
   6.1%
Within
69
  93.2%
45
  91.8%
Above
0
   0.0%
1
   2.0%
Platelets Unknown
0
   0.0%
0
   0.0%
Below
4
   5.4%
1
   2.0%
Within
70
  94.6%
48
  98.0%
Above
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Hide Description The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 73 45
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
67
  91.8%
41
  91.1%
Above
6
   8.2%
4
   8.9%
Albumin Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
69
  94.5%
43
  95.6%
Above
4
   5.5%
2
   4.4%
Alkaline Phosphatase Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
71
  97.3%
43
  95.6%
Above
2
   2.7%
2
   4.4%
Aspartate Aminotransferase Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
69
  94.5%
42
  93.3%
Above
4
   5.5%
3
   6.7%
Basophils Unknown
1
   1.4%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
72
  98.6%
45
 100.0%
Above
0
   0.0%
0
   0.0%
Total Bilirubin Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
65
  89.0%
42
  93.3%
Above
8
  11.0%
3
   6.7%
Bilirubin Conjugated/Direct Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
73
 100.0%
44
  97.8%
Above
0
   0.0%
1
   2.2%
Creatinine Unknown
0
   0.0%
0
   0.0%
Below
4
   5.5%
7
  15.6%
Within
66
  90.4%
38
  84.4%
Above
3
   4.1%
0
   0.0%
Eosinophils Unknown
1
   1.4%
0
   0.0%
Below
13
  17.8%
6
  13.3%
Within
57
  78.1%
39
  86.7%
Above
2
   2.7%
0
   0.0%
Glucose Unknown
0
   0.0%
0
   0.0%
Below
2
   2.7%
1
   2.2%
Within
62
  84.9%
34
  75.6%
Above
9
  12.3%
10
  22.2%
Bicarbonate Unknown
0
   0.0%
0
   0.0%
Below
7
   9.6%
1
   2.2%
Within
66
  90.4%
44
  97.8%
Above
0
   0.0%
0
   0.0%
Haemoglobin Unknown
1
   1.4%
0
   0.0%
Below
12
  16.4%
3
   6.7%
Within
57
  78.1%
40
  88.9%
Above
3
   4.1%
2
   4.4%
Potassium Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
1
   2.2%
Within
73
 100.0%
44
  97.8%
Above
0
   0.0%
0
   0.0%
Lymphocytes Unknown
1
   1.4%
0
   0.0%
Below
1
   1.4%
0
   0.0%
Within
71
  97.3%
45
 100.0%
Above
0
   0.0%
0
   0.0%
Monocytes Unknown
1
   1.4%
0
   0.0%
Below
6
   8.2%
3
   6.7%
Within
66
  90.4%
42
  93.3%
Above
0
   0.0%
0
   0.0%
Sodium Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
1
   2.2%
Within
73
 100.0%
44
  97.8%
Above
0
   0.0%
0
   0.0%
Neutrophils Unknown
1
   1.4%
0
   0.0%
Below
8
  11.0%
3
   6.7%
Within
64
  87.7%
40
  88.9%
Above
0
   0.0%
2
   4.4%
Platelets Unknown
1
   1.4%
0
   0.0%
Below
2
   2.7%
3
   6.7%
Within
70
  95.9%
42
  93.3%
Above
0
   0.0%
0
   0.0%
White Blood Cells Unknown
1
   1.4%
0
   0.0%
Below
5
   6.8%
4
   8.9%
Within
67
  91.8%
39
  86.7%
Above
0
   0.0%
2
   4.4%
10.Primary Outcome
Title Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Hide Description The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 71 47
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
67
  94.4%
40
  85.1%
Above
4
   5.6%
6
  12.8%
Albumin Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
67
  94.4%
44
  93.6%
Above
4
   5.6%
2
   4.3%
Alkaline Phosphatase Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
68
  95.8%
42
  89.4%
Above
3
   4.2%
4
   8.5%
Aspartate Aminotransferase Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
67
  94.4%
43
  91.5%
Above
4
   5.6%
3
   6.4%
Basophils Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
70
  98.6%
45
  95.7%
Above
0
   0.0%
0
   0.0%
Total Bilirubin Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
64
  90.1%
44
  93.6%
Above
7
   9.9%
2
   4.3%
Bilirubin Conjugated/Direct Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
69
  97.2%
46
  97.9%
Above
2
   2.8%
0
   0.0%
Creatinine Unknown
0
   0.0%
1
   2.1%
Below
5
   7.0%
7
  14.9%
Within
65
  91.5%
39
  83.0%
Above
1
   1.4%
0
   0.0%
Eosinophils Unknown
1
   1.4%
2
   4.3%
Below
9
  12.7%
7
  14.9%
Within
61
  85.9%
37
  78.7%
Above
0
   0.0%
1
   2.1%
Glucose Unknown
0
   0.0%
1
   2.1%
Below
2
   2.8%
0
   0.0%
Within
59
  83.1%
38
  80.9%
Above
10
  14.1%
8
  17.0%
Bicarbonate Unknown
0
   0.0%
1
   2.1%
Below
2
   2.8%
0
   0.0%
Within
69
  97.2%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Haemoglobin Unknown
1
   1.4%
2
   4.3%
Below
15
  21.1%
5
  10.6%
Within
53
  74.6%
38
  80.9%
Above
2
   2.8%
2
   4.3%
Potassium Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
70
  98.6%
46
  97.9%
Above
1
   1.4%
0
   0.0%
Lymphocytes Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
1
   2.1%
Within
68
  95.8%
44
  93.6%
Above
2
   2.8%
0
   0.0%
Monocytes Unknown
1
   1.4%
2
   4.3%
Below
4
   5.6%
4
   8.5%
Within
66
  93.0%
41
  87.2%
Above
0
   0.0%
0
   0.0%
Sodium Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
70
  98.6%
46
  97.9%
Above
1
   1.4%
0
   0.0%
Neutrophils Unknown
1
   1.4%
2
   4.3%
Below
7
   9.9%
1
   2.1%
Within
63
  88.7%
43
  91.5%
Above
0
   0.0%
1
   2.1%
Platelets Unknown
1
   1.4%
2
   4.3%
Below
1
   1.4%
2
   4.3%
Within
69
  97.2%
43
  91.5%
Above
0
   0.0%
0
   0.0%
White Blood Cells Unknown
1
   1.4%
2
   4.3%
Below
6
   8.5%
2
   4.3%
Within
64
  90.1%
41
  87.2%
Above
0
   0.0%
2
   4.3%
11.Primary Outcome
Title Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Hide Description The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 72 47
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
66
  91.7%
36
  76.6%
Above
5
   6.9%
9
  19.1%
Albumin Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
67
  93.1%
43
  91.5%
Above
4
   5.6%
2
   4.3%
Alkaline Phosphatase Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
67
  93.1%
40
  85.1%
Above
4
   5.6%
5
  10.6%
Aspartate Aminotransferase Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
68
  94.4%
41
  87.2%
Above
3
   4.2%
4
   8.5%
Basophils Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
72
 100.0%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Total Bilirubin Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
61
  84.7%
43
  91.5%
Above
10
  13.9%
2
   4.3%
Bilirubin Conjugated/Direct Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
70
  97.2%
44
  93.6%
Above
1
   1.4%
1
   2.1%
Creatinine Unknown
1
   1.4%
2
   4.3%
Below
5
   6.9%
7
  14.9%
Within
66
  91.7%
37
  78.7%
Above
0
   0.0%
1
   2.1%
Eosinophils Unknown
0
   0.0%
1
   2.1%
Below
12
  16.7%
5
  10.6%
Within
59
  81.9%
41
  87.2%
Above
1
   1.4%
0
   0.0%
Glucose Unknown
1
   1.4%
2
   4.3%
Below
2
   2.8%
0
   0.0%
Within
62
  86.1%
38
  80.9%
Above
7
   9.7%
7
  14.9%
Bicarbonate Unknown
1
   1.4%
2
   4.3%
Below
5
   6.9%
2
   4.3%
Within
66
  91.7%
43
  91.5%
Above
0
   0.0%
0
   0.0%
Haemoglobin Unknown
0
   0.0%
1
   2.1%
Below
14
  19.4%
5
  10.6%
Within
57
  79.2%
37
  78.7%
Above
1
   1.4%
4
   8.5%
Potassium Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
71
  98.6%
45
  95.7%
Above
0
   0.0%
0
   0.0%
Lymphocytes Unknown
0
   0.0%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
72
 100.0%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Monocytes Unknown
0
   0.0%
1
   2.1%
Below
6
   8.3%
6
  12.8%
Within
66
  91.7%
40
  85.1%
Above
0
   0.0%
0
   0.0%
Sodium Unknown
1
   1.4%
2
   4.3%
Below
0
   0.0%
0
   0.0%
Within
71
  98.6%
45
  95.7%
Above
0
   0.0%
0
   0.0%
Neutrophils Unknown
0
   0.0%
1
   2.1%
Below
6
   8.3%
5
  10.6%
Within
66
  91.7%
39
  83.0%
Above
0
   0.0%
2
   4.3%
Platelets Unknown
0
   0.0%
1
   2.1%
Below
3
   4.2%
2
   4.3%
Within
69
  95.8%
44
  93.6%
Above
0
   0.0%
0
   0.0%
White Blood Cells Unknown
0
   0.0%
1
   2.1%
Below
5
   6.9%
7
  14.9%
Within
67
  93.1%
37
  78.7%
Above
0
   0.0%
2
   4.3%
12.Primary Outcome
Title Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Hide Description The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 71 47
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
67
  94.4%
41
  87.2%
Above
4
   5.6%
6
  12.8%
Albumin Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
68
  95.8%
44
  93.6%
Above
3
   4.2%
3
   6.4%
Alkaline Phosphatase Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
67
  94.4%
42
  89.4%
Above
4
   5.6%
5
  10.6%
Aspartate Aminotransferase Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
66
  93.0%
45
  95.7%
Above
5
   7.0%
2
   4.3%
Basophils Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
69
  97.2%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Total Bilirubin Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
60
  84.5%
45
  95.7%
Above
11
  15.5%
2
   4.3%
Bilirubin Conjugated/Direct Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
68
  95.8%
46
  97.9%
Above
3
   4.2%
1
   2.1%
Creatinine Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
7
   9.9%
7
  14.9%
Within
62
  87.3%
39
  83.0%
Above
2
   2.8%
1
   2.1%
Eosinophils Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
13
  18.3%
9
  19.1%
Within
55
  77.5%
36
  76.6%
Above
1
   1.4%
1
   2.1%
Glucose Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
1
   1.4%
1
   2.1%
Within
62
  87.3%
37
  78.7%
Above
8
  11.3%
9
  19.1%
Bicarbonate Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
7
   9.9%
7
  14.9%
Within
63
  88.7%
40
  85.1%
Above
1
   1.4%
0
   0.0%
Haemoglobin Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
13
  18.3%
6
  12.8%
Within
55
  77.5%
37
  78.7%
Above
1
   1.4%
3
   6.4%
Potassium Number Analyzed 70 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
70
 100.0%
47
 100.0%
Above
0
   0.0%
0
   0.0%
Lymphocytes Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
4
   5.6%
3
   6.4%
Within
65
  91.5%
42
  89.4%
Above
0
   0.0%
1
   2.1%
Monocytes Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
2
   2.8%
4
   8.5%
Within
67
  94.4%
42
  89.4%
Above
0
   0.0%
0
   0.0%
Sodium Number Analyzed 71 participants 47 participants
Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
71
 100.0%
47
 100.0%
Above
0
   0.0%
0
   0.0%
Neutrophils Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
5
   7.0%
5
  10.6%
Within
64
  90.1%
37
  78.7%
Above
0
   0.0%
4
   8.5%
Platelets Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
2
   2.8%
2
   4.3%
Within
67
  94.4%
44
  93.6%
Above
0
   0.0%
0
   0.0%
White Blood Cells Number Analyzed 71 participants 47 participants
Unknown
2
   2.8%
1
   2.1%
Below
6
   8.5%
4
   8.5%
Within
62
  87.3%
39
  83.0%
Above
1
   1.4%
3
   6.4%
13.Primary Outcome
Title Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
Hide Description The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 68 47
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
64
  94.1%
42
  89.4%
Above
3
   4.4%
4
   8.5%
Albumin Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
1
   2.1%
Within
64
  94.1%
41
  87.2%
Above
3
   4.4%
4
   8.5%
Alkaline Phosphatase Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
63
  92.6%
42
  89.4%
Above
4
   5.9%
4
   8.5%
Aspartate Aminotransferase Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
65
  95.6%
43
  91.5%
Above
2
   2.9%
3
   6.4%
Basophils Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
0
   0.0%
Within
68
 100.0%
47
 100.0%
Above
0
   0.0%
0
   0.0%
Total Bilirubin Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
57
  83.8%
43
  91.5%
Above
10
  14.7%
3
   6.4%
Bilirubin Conjugated/Direct Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
67
  98.5%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Creatinine Unknown
1
   1.5%
1
   2.1%
Below
7
  10.3%
6
  12.8%
Within
57
  83.8%
39
  83.0%
Above
3
   4.4%
1
   2.1%
Eosinophils Unknown
0
   0.0%
0
   0.0%
Below
11
  16.2%
7
  14.9%
Within
56
  82.4%
39
  83.0%
Above
1
   1.5%
1
   2.1%
Glucose Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
63
  92.6%
39
  83.0%
Above
4
   5.9%
7
  14.9%
Bicarbonate Unknown
1
   1.5%
1
   2.1%
Below
6
   8.8%
4
   8.5%
Within
61
  89.7%
42
  89.4%
Above
0
   0.0%
0
   0.0%
Haemoglobin Unknown
0
   0.0%
0
   0.0%
Below
19
  27.9%
6
  12.8%
Within
49
  72.1%
40
  85.1%
Above
0
   0.0%
1
   2.1%
Potassium Unknown
1
   1.5%
1
   2.1%
Below
1
   1.5%
0
   0.0%
Within
66
  97.1%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Lymphocytes Unknown
0
   0.0%
0
   0.0%
Below
0
   0.0%
1
   2.1%
Within
67
  98.5%
46
  97.9%
Above
1
   1.5%
0
   0.0%
Monocytes Unknown
0
   0.0%
0
   0.0%
Below
5
   7.4%
2
   4.3%
Within
63
  92.6%
45
  95.7%
Above
0
   0.0%
0
   0.0%
Sodium Unknown
1
   1.5%
1
   2.1%
Below
0
   0.0%
0
   0.0%
Within
67
  98.5%
46
  97.9%
Above
0
   0.0%
0
   0.0%
Neutrophils Unknown
0
   0.0%
0
   0.0%
Below
7
  10.3%
1
   2.1%
Within
61
  89.7%
44
  93.6%
Above
0
   0.0%
2
   4.3%
Platelets Unknown
0
   0.0%
0
   0.0%
Below
2
   2.9%
1
   2.1%
Within
66
  97.1%
46
  97.9%
Above
0
   0.0%
0
   0.0%
White Blood Cells Unknown
0
   0.0%
0
   0.0%
Below
6
   8.8%
1
   2.1%
Within
62
  91.2%
44
  93.6%
Above
0
   0.0%
2
   4.3%
14.Primary Outcome
Title Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects
Hide Description In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.
Time Frame From Month 0 until Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Failure to control HIV viral load
0
   0.0%
0
   0.0%
Failure to maintain high CD4 cells count
0
   0.0%
0
   0.0%
15.Primary Outcome
Title Number of Subjects With Any AIDS-defining Condition
Hide Description In this analysis, results were tabulated for the main study groups.
Time Frame From Month 0 until Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Primary Outcome
Title Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count
Hide Description In this analysis, results were tabulated for the main study groups.
Time Frame From Month 1 to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
Change in HIV viral load
3
   4.1%
1
   2.0%
Change in CD4 cells count
7
   9.5%
4
   8.2%
17.Primary Outcome
Title Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status
Hide Description In this analysis, results were tabulated by HIV status
Time Frame From Month 0 to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 56 38 9 5 9 6
Measure Type: Count of Participants
Unit of Measure: Participants
Due to failure to control HIV viral load
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Due to failure to maintain high CD4 cells count
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18.Primary Outcome
Title Number of Subjects With Any AIDS-defining Condition, by HIV Status
Hide Description In this analysis, results were tabulated by HIV status
Time Frame From Month 0 to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 56 38 9 5 9 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Primary Outcome
Title Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status
Hide Description In this analysis, results were tabulated by HIV status.
Time Frame From Month 1 to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 56 38 9 5 9 6
Measure Type: Count of Participants
Unit of Measure: Participants
Change in HIV viral load
1
   1.8%
0
   0.0%
1
  11.1%
0
   0.0%
1
  11.1%
1
  16.7%
Change in CD4 cells count
5
   8.9%
3
   7.9%
1
  11.1%
1
  20.0%
1
  11.1%
0
   0.0%
20.Primary Outcome
Title Frequency of gE-specific CD4 T-cells
Hide Description The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.
Time Frame At Month 7
Hide 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 measures were available at Month 7.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 30 20
Mean (Standard Deviation)
Unit of Measure: CD4 T-cells/million T-cells
4684.50  (5376.83) 158.64  (151.15)
21.Primary Outcome
Title -Anti-gE Antibody (Ab) Concentrations
Hide Description -Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 54 36
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
63812.6
(51183.6 to 79557.7)
1028.4
(658.9 to 1605.0)
22.Secondary Outcome
Title -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
Hide Description The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.
Time Frame At Month 0, 1, 2, 3, 6, 7 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 49 35
Mean (Standard Deviation)
Unit of Measure: CD4 T-cells/million T-cells
VZV-specific CD4 [2+] T-cells, pre-vaccination Number Analyzed 32 participants 27 participants
750.20  (989.36) 835.80  (1949.39)
VZV-specific CD4 [2+] T-cells, Month 1 Number Analyzed 40 participants 26 participants
768.60  (739.68) 913.87  (2262.66)
VZV-specific CD4 [2+] T-cells, Month 2 Number Analyzed 37 participants 26 participants
734.09  (680.34) 874.13  (2027.95)
VZV-specific CD4 [2+] T-cells, Month 3 Number Analyzed 41 participants 28 participants
1878.81  (1615.20) 987.24  (1988.86)
VZV-specific CD4 [2+] T-cells, Month 6 Number Analyzed 29 participants 19 participants
1646.83  (1202.32) 674.20  (657.00)
VZV-specific CD4 [2+] T-cells, Month 7 Number Analyzed 30 participants 20 participants
2626.71  (2514.40) 1204.44  (1911.53)
VZV-specific CD4 [2+] T-cells, Month 18 Number Analyzed 48 participants 35 participants
995.35  (842.96) 531.24  (579.63)
gE-specific CD4 [2+] T-cells, pre-vaccination Number Analyzed 33 participants 27 participants
218.26  (254.94) 123.15  (170.79)
gE-specific CD4 [2+] T-cells, Month 1 Number Analyzed 40 participants 26 participants
704.06  (614.49) 132.49  (213.05)
gE-specific CD4 [2+] T-cells, Month 2 Number Analyzed 38 participants 26 participants
649.68  (555.51) 140.95  (197.99)
gE-specific CD4 [2+] T-cells, Month 3 Number Analyzed 41 participants 28 participants
3503.69  (2971.74) 160.10  (220.32)
gE-specific CD4 [2+] T-cells, Month 6 Number Analyzed 29 participants 19 participants
2647.71  (1972.00) 133.70  (137.94)
gE-specific CD4 [2+] T-cells, Month 7 Number Analyzed 30 participants 20 participants
4684.50  (5376.83) 158.64  (151.15)
gE-specific CD4 [2+] T-cells, Month 18 Number Analyzed 49 participants 35 participants
1929.30  (1603.50) 139.50  (219.57)
23.Secondary Outcome
Title -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
Hide Description The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.
Time Frame At Months 0, 1, 2, 3, 6, 7 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 40 28 5 3 5 4
Mean (Standard Deviation)
Unit of Measure: CD4 T-cells/million T-cells
VZV-specific CD4 [2+] T-cells, pre-vaccination Number Analyzed 27 participants 24 participants 2 participants 1 participants 3 participants 2 participants
789.48  (1037.59) 927.27  (2053.32) 1.00  (0.00) 86.96 [1]   (NA) 896.13  (749.70) 112.66  (157.91)
VZV-specific CD4 [2+] T-cells, Month 1 Number Analyzed 30 participants 22 participants 5 participants 2 participants 5 participants 2 participants
830.78  (775.61) 1049.73  (2442.95) 114.79  (114.03) 146.91  (142.99) 1049.36  (546.09) 186.38  (31.21)
VZV-specific CD4 [2+] T-cells, Month 2 Number Analyzed 28 participants 22 participants 4 participants 2 participants 5 participants 2 participants
716.33  (699.22) 991.07  (2190.70) 814.64  (920.49) 329.96  (53.46) 769.13  (469.02) 131.90  (185.13)
VZV-specific CD4 [2+] T-cells, Month 3 Number Analyzed 33 participants 22 participants 3 participants 3 participants 5 participants 3 participants
1973.47  (1669.57) 1075.62  (2186.45) 1804.94  (2350.96) 408.18  (330.78) 1298.35  (725.44) 918.17  (1580.86)
VZV-specific CD4 [2+] T-cells, Month 6 Number Analyzed 25 participants 16 participants 3 participants 1 participants 1 participants 2 participants
1624.32  (1161.05) 786.72  (657.24) 1996.37  (1937.58) 136.42 [1]   (NA) 1160.93 [1]   (NA) 42.92  (37.09)
VZV-specific CD4 [2+] T-cells, Month 7 Number Analyzed 26 participants 19 participants 3 participants 1 participants 1 participants 0 participants
2285.90  (1998.16) 1261.84  (1946.12) 6235.67  (4334.14) 113.88 [1]   (NA) 660.88 [1]   (NA)
VZV-specific CD4 [2+] T-cells, Month 18 Number Analyzed 40 participants 28 participants 3 participants 3 participants 5 participants 4 participants
1051.12  (816.86) 599.00  (587.08) 853.05  (1235.35) 580.71  (683.08) 634.55  (933.54) 19.77  (22.14)
gE-specific CD4 [2+] T-cells, pre-vaccination Number Analyzed 28 participants 24 participants 2 participants 1 participants 3 participants 2 participants
215.99  (266.22) 136.29  (176.85) 51.15  (70.92) 1.00 [1]   (NA) 350.86  (161.96) 26.57  (36.17)
gE-specific CD4 [2+] T-cells, Month 1 Number Analyzed 30 participants 22 participants 5 participants 2 participants 5 participants 2 participants
682.62  (595.89) 134.21  (224.96) 584.10  (652.67) 161.73  (227.30) 952.65  (763.24) 84.33  (117.84)
gE-specific CD4 [2+] T-cells, Month 2 Number Analyzed 29 participants 22 participants 4 participants 2 participants 5 participants 2 participants
610.30  (558.27) 157.92  (208.48) 960.39  (632.86) 94.19  (131.79) 629.54  (513.99) 1.00  (0.00)
gE-specific CD4 [2+] T-cells, Month 3 Number Analyzed 33 participants 22 participants 3 participants 3 participants 5 participants 3 participants
3722.21  (2789.70) 190.58  (233.81) 4754.94  (6004.05) 1.00  (0.00) 1310.76  (670.56) 95.71  (164.04)
gE-specific CD4 [2+] T-cells, Month 6 Number Analyzed 25 participants 16 participants 3 participants 1 participants 1 participants 2 participants
2386.40  (1571.28) 152.52  (141.50) 5403.79  (3326.03) 97.99 [1]   (NA) 912.30 [1]   (NA) 1.00  (0.00)
gE-specific CD4 [2+] T-cells, Month 7 Number Analyzed 26 participants 19 participants 3 participants 1 participants 1 participants 0 participants
3649.92  (3112.69) 166.94  (150.54) 14925.30  (10934.07) 1.00 [1]   (NA) 861.21 [1]   (NA)
gE-specific CD4 [2+] T-cells, Month 18 Number Analyzed 40 participants 28 participants 4 participants 3 participants 5 participants 4 participants
2071.17  (1583.58) 159.05  (239.50) 2035.18  (2100.82) 109.97  (93.90) 709.62  (1011.03) 24.81  (47.63)
[1]
There were not enough subjects for SD analysis to be computed.
24.Secondary Outcome
Title -Anti-VZV and Anti-gE Antibody Concentrations
Hide Description Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Time Frame At Months 0, 1, 2, 3, 6, 7 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 54 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-VZV, Pre-vaccination Number Analyzed 48 participants 36 participants
1292.7
(999.8 to 1671.4)
1074.7
(672.7 to 1717.0)
Anti-VZV, Month 1 Number Analyzed 43 participants 33 participants
6953.8
(5425.1 to 8913.3)
1173.8
(762.9 to 1805.8)
Anti-VZV, Month 2 Number Analyzed 45 participants 33 participants
5170.9
(4032.7 to 6630.4)
987.6
(596.3 to 1635.8)
Anti-VZV, Month 3 Number Analyzed 50 participants 33 participants
11119.7
(9190.8 to 13453.3)
1037.8
(620.2 to 1736.5)
Anti-VZV, Month 6 Number Analyzed 49 participants 34 participants
8244.0
(6678.6 to 10176.3)
1069.8
(653.3 to 1751.7)
Anti-VZV, Month 7 Number Analyzed 49 participants 32 participants
14560.8
(11849.0 to 17893.1)
999.3
(598.3 to 1669.2)
Anti-VZV, Month 18 Number Analyzed 46 participants 29 participants
7493.3
(5926.7 to 9473.9)
922.9
(521.1 to 1634.6)
Anti-gE, Pre-vaccination Number Analyzed 53 participants 37 participants
1218.4
(895.0 to 1658.7)
849.5
(551.1 to 1309.4)
Anti-gE, Month 1 Number Analyzed 54 participants 36 participants
24113.2
(18317.4 to 31743.0)
1059.0
(749.4 to 1496.5)
Anti-gE, Month 2 Number Analyzed 53 participants 37 participants
17112.6
(12929.5 to 22649.1)
903.3
(590.9 to 1380.9)
Anti-gE, Month 3 Number Analyzed 54 participants 37 participants
50443.0
(40899.6 to 62213.2)
992.9
(647.4 to 1522.6)
Anti-gE, Month 6 Number Analyzed 54 participants 37 participants
34159.4
(27221.0 to 42866.2)
1013.1
(660.5 to 1553.7)
Anti-gE, Month 7 Number Analyzed 54 participants 37 participants
63812.6
(51183.6 to 79557.7)
1028.4
(658.9 to 1605.0)
Anti-gE, Month 18 Number Analyzed 49 participants 37 participants
25242.2
(19618.9 to 32477.3)
918.0
(588.0 to 1433.1)
25.Secondary Outcome
Title -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Hide Description Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Time Frame At Months 0, 1, 2, 3, 6, 7 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 44 30 5 4 5 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-VZV, Pre-vaccination Number Analyzed 38 participants 29 participants 5 participants 3 participants 5 participants 4 participants
1161.5
(900.3 to 1498.6)
985.1
(568.7 to 1706.4)
2272.6
(559.1 to 9236.6)
2511.9
(693.0 to 9104.4)
1658.0
(315.9 to 8701.1)
1068.5
(117.3 to 9735.4)
Anti-VZV, Month 1 Number Analyzed 34 participants 26 participants 4 participants 3 participants 5 participants 4 participants
7017.8
(5441.2 to 9051.3)
1059.6
(641.1 to 1751.2)
6731.0
(572.7 to 79107.0)
2871.0
(1386.7 to 5944.3)
6706.0
(2477.9 to 18148.5)
1167.3
(130.1 to 10475.4)
Anti-VZV, Month 2 Number Analyzed 38 participants 27 participants 4 participants 2 participants 3 participants 4 participants
5056.5
(3973.9 to 6434.0)
886.9
(498.6 to 1577.4)
5649.6
(418.4 to 76276.9)
2902.1
(1.9 to 4493973)
6100.0
(480.4 to 77462.7)
1191.1
(119.6 to 11860.7)
Anti-VZV, Month 3 Number Analyzed 41 participants 28 participants 5 participants 1 participants 4 participants 4 participants
11631.9
(9523.8 to 14206.6)
1002.7
(565.8 to 1777.1)
9110.7
(2224.8 to 37308.9)
2479.3 [1] 
(NA to NA)
8990.7
(5233.1 to 15446.6)
1062.0
(81.1 to 13906.2)
Anti-VZV, Month 6 Number Analyzed 39 participants 27 participants 5 participants 3 participants 5 participants 4 participants
9027.6
(7225.1 to 11279.6)
957.0
(537.2 to 1705.0)
7634.7
(2054.6 to 28369.5)
3164.8
(510.5 to 19621.7)
4384.3
(2322.5 to 8276.5)
1006.3
(115.7 to 8754.6)
Anti-VZV, Month 7 Number Analyzed 40 participants 26 participants 5 participants 2 participants 4 participants 4 participants
15278.5
(12420.2 to 18794.5)
930.5
(511.6 to 1692.3)
14763.2
(2859.6 to 76216.1)
2177.3
(8.7 to 544573.1)
8845.8
(5463.6 to 14321.5)
1076.7
(109.5 to 10591.1)
Anti-VZV, Month 18 Number Analyzed 37 participants 24 participants 4 participants 2 participants 5 participants 3 participants
8242.2
(6484.1 to 10476.9)
838.1
(435.9 to 1611.5)
6106.2
(748.6 to 49809.5)
1955.3
(188.8 to 20249.5)
4361.7
(1721.5 to 11050.9)
1209.2
(13.9 to 105230.8)
Anti-gE, Pre-vaccination Number Analyzed 43 participants 30 participants 5 participants 3 participants 5 participants 4 participants
1113.2
(794.3 to 1560.3)
791.0
(490.7 to 1275.1)
1845.1
(465.1 to 7319.1)
2420.7
(512.0 to 11445.2)
1748.6
(308.5 to 9912.2)
661.2
(43.8 to 9984.8)
Anti-gE, Month 1 Number Analyzed 44 participants 29 participants 5 participants 3 participants 5 participants 4 participants
25530.6
(19158.6 to 34021.9)
1029.5
(719.5 to 1473.1)
18767.2
(2219.4 to 158697.1)
2328.1
(446.4 to 12141.8)
18742.3
(6616.7 to 53089.1)
720.0
(50.6 to 10238.5)
Anti-gE, Month 2 Number Analyzed 43 participants 30 participants 5 participants 3 participants 5 participants 4 participants
18208.6
(13537.4 to 24491.6)
839.8
(524.6 to 1344.4)
13106.4
(1619.0 to 106104.2)
2465.5
(561.9 to 10817.4)
13100.6
(4828.6 to 35543.7)
735.0
(52.7 to 10245.9)
Anti-gE, Month 3 Number Analyzed 44 participants 30 participants 5 participants 3 participants 5 participants 4 participants
54777.7
(44077.1 to 68076.1)
955.6
(590.6 to 1546.2)
36592.6
(7026.0 to 190581.1)
2166.3
(618.9 to 7583.1)
33662.4
(20665.6 to 54833.0)
736.6
(52.1 to 10414.5)
Anti-gE, Month 6 Number Analyzed 44 participants 30 participants 5 participants 3 participants 5 participants 4 participants
38068.2
(29964.3 to 48363.7)
932.8
(582.6 to 1493.3)
24725.0
(5143.2 to 118862.3)
2629.2
(561.7 to 12306.8)
18189.6
(11258.0 to 29389.0)
920.6
(54.8 to 15461.5)
Anti-gE, Month 7 Number Analyzed 44 participants 29 participants 5 participants 3 participants 5 participants 4 participants
71309.6
(57019.3 to 89181.5)
928.8
(566.8 to 1522.1)
47382.6
(9151.2 to 245336.2)
2553.0
(610.1 to 10683.1)
32334.6
(17277.6 to 60513.4)
1087.6
(60.2 to 19641.4)
Anti-gE, Month 18 Number Analyzed 40 participants 29 participants 4 participants 4 participants 5 participants 4 participants
28854.6
(22512.5 to 36983.3)
849.4
(514.6 to 1401.9)
18995.8
(1733.3 to 208181.4)
1953.7
(572.7 to 6665.3)
10869.2
(4435.4 to 26635.7)
757.8
(34.8 to 16519.1)
[1]
There were not enough subjects for a Lower Limit (LL) and Upper Limit (UL) to be computed.
26.Secondary Outcome
Title Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications
Hide Description [Not Specified]
Time Frame From Month 0 until Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 74 49
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
0
   0.0%
27.Secondary Outcome
Title CD4 Count
Hide Description CD4 count was tabulated by HIV status.
Time Frame At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 56 38 9 5 9 6
Mean (Standard Deviation)
Unit of Measure: CD4 T-cells/million T-cells
CD4+, pre-vaccination Number Analyzed 56 participants 38 participants 9 participants 5 participants 9 participants 6 participants
631.46  (236.36) 683.39  (228.29) 152.11  (38.39) 132.20  (11.19) 805.33  (132.38) 901.67  (177.61)
CD4+, Month 1 Number Analyzed 55 participants 35 participants 9 participants 5 participants 9 participants 5 participants
630.55  (241.78) 694.69  (307.98) 151.11  (38.72) 163.00  (53.66) 879.67  (277.37) 773.40  (144.85)
CD4+, Month 2 Number Analyzed 54 participants 36 participants 8 participants 4 participants 8 participants 5 participants
667.69  (309.22) 656.14  (262.43) 131.13  (39.57) 133.75  (31.86) 808.75  (211.32) 804.00  (199.09)
CD4+, Month 3 Number Analyzed 55 participants 36 participants 9 participants 5 participants 8 participants 5 participants
633.60  (228.75) 640.14  (238.05) 153.11  (54.27) 142.60  (36.49) 783.63  (239.92) 762.60  (185.66)
CD4+, Month 6 Number Analyzed 53 participants 36 participants 9 participants 5 participants 7 participants 5 participants
655.02  (264.67) 668.28  (308.64) 145.33  (29.74) 145.20  (43.18) 776.43  (303.30) 1082.80  (649.82)
CD4+, Month 7 Number Analyzed 54 participants 37 participants 8 participants 5 participants 7 participants 5 participants
654.69  (271.31) 658.81  (246.53) 170.25  (44.52) 150.40  (35.11) 869.14  (297.04) 866.00  (144.30)
CD4+, Month 18 Number Analyzed 51 participants 35 participants 7 participants 5 participants 7 participants 5 participants
679.71  (247.57) 651.06  (247.30) 168.43  (58.49) 151.40  (57.48) 720.00  (228.77) 824.40  (207.57)
28.Secondary Outcome
Title HIV VL
Hide Description HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.
Time Frame At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.
Arm/Group Title Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A ART High CD4 Cohort - Placebo ART Low CD4 Cohort - GSK 1437173A ART Low CD4 Cohort - Placebo Non-ART High CD4 Cohort - GSK 1437173A Non-ART High CD4 Cohort - Placebo
Hide Arm/Group Description:
ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
Overall Number of Participants Analyzed 4 4 2 1 9 6
Mean (Standard Deviation)
Unit of Measure: HIV-RNA copies/mL
HIV VL, pre-vaccination Number Analyzed 0 participants 0 participants 1 participants 0 participants 9 participants 6 participants
62.00 [1]   (NA) 23014.11  (18435.10) 16022.17  (23652.18)
HIV VL, Month 1 Number Analyzed 1 participants 0 participants 1 participants 0 participants 9 participants 5 participants
42.00 [1]   (NA) 48.00 [1]   (NA) 24538.89  (19056.10) 14415.80  (9289.92)
HIV VL, Month 2 Number Analyzed 3 participants 1 participants 2 participants 0 participants 8 participants 4 participants
48.67  (10.79) 55.00 [1]   (NA) 48.00  (2.83) 24134.25  (13753.92) 18188.25  (15199.35)
HIV VL, Month 3 Number Analyzed 3 participants 0 participants 1 participants 0 participants 8 participants 5 participants
75.00  (37.75) 84.00 [1]   (NA) 19453.50  (11878.74) 16270.00  (15785.91)
HIV VL, Month 6 Number Analyzed 4 participants 1 participants 2 participants 1 participants 7 participants 5 participants
19699.25  (39272.50) 112.00 [1]   (NA) 66053.50  (93328.90) 51.00 [1]   (NA) 37091.29  (33678.60) 46429.60  (52567.42)
HIV VL, Month 7 Number Analyzed 3 participants 4 participants 1 participants 0 participants 7 participants 5 participants
530.67  (785.50) 55.75  (6.29) 248.00 [1]   (NA) 35534.00  (39549.42) 25774.60  (27360.66)
HIV VL, Month 18 Number Analyzed 3 participants 3 participants 1 participants 0 participants 7 participants 5 participants
70.33  (29.54) 92.67  (64.53) 48.00 [1]   (NA) 60597.00  (48313.15) 14742.60  (18306.17)
[1]
There were not enough subjects for SD analysis to be computed.
Time Frame Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
All-Cause Mortality
GSK1437173A Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/49 (0.00%) 
Hide Serious Adverse Events
GSK1437173A Group Placebo Group
Affected