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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier

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ClinicalTrials.gov Identifier: NCT02581410
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : September 26, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Herpes Zoster
Intervention Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Enrollment 430
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description Subjects above or equal to (≥) 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study. Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
Period Title: Vaccination Phase
Started 215 215
Completed 213 212
Not Completed 2 3
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             0             1
Migrated/moved from study area             0             1
Period Title: End of Study Phase
Started 215 215
Completed 210 204
Not Completed 5 11
Reason Not Completed
Adverse Event             4             3
Withdrawal by Subject             1             2
Migrated/moved from study area             0             3
Lost to Follow-up             0             2
Other-transfer of subject not completed             0             1
Arm/Group Title GSK1437173A Group Control Group Total
Hide Arm/Group Description Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study. Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study. Total of all reporting groups
Overall Number of Baseline Participants 215 215 430
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants 215 participants 430 participants
71.1  (4.5) 70.8  (4.6) 70.9  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 215 participants 430 participants
Female
109
  50.7%
111
  51.6%
220
  51.2%
Male
106
  49.3%
104
  48.4%
210
  48.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White - Caucasian / European Heritage Number Analyzed 215 participants 215 participants 430 participants
White - Caucasian / European Heritage
215
 100.0%
215
 100.0%
430
 100.0%
1.Primary Outcome
Title Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations
Hide Description Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.
Time Frame One month after dose 2, at Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available at Month 3.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 204 204
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
50522.9
(44347.4 to 57558.4)
48589.4
(42649.4 to 55356.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1437173A Group, Control Group
Comments To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).
Type of Statistical Test Non-Inferiority
Comments Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.92 to 1.17
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) period after each dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 214
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 215 participants 214 participants
171
  79.5%
159
  74.3%
Grade 3 Pain, Dose 1 Number Analyzed 215 participants 214 participants
8
   3.7%
7
   3.3%
Any Redness, Dose 1 Number Analyzed 215 participants 214 participants
69
  32.1%
48
  22.4%
Grade 3 Redness, Dose 1 Number Analyzed 215 participants 214 participants
3
   1.4%
2
   0.9%
Any Swelling, Dose 1 Number Analyzed 215 participants 214 participants
29
  13.5%
21
   9.8%
Grade 3 Swelling, Dose 1 Number Analyzed 215 participants 214 participants
1
   0.5%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 208 participants 211 participants
163
  78.4%
161
  76.3%
Grade 3 Pain, Dose 2 Number Analyzed 208 participants 211 participants
5
   2.4%
10
   4.7%
Any Redness, Dose 2 Number Analyzed 208 participants 211 participants
69
  33.2%
53
  25.1%
Grade 3 Redness, Dose 2 Number Analyzed 208 participants 211 participants
6
   2.9%
2
   0.9%
Any Swelling, Dose 2 Number Analyzed 208 participants 211 participants
29
  13.9%
27
  12.8%
Grade 3 Swelling, Dose 2 Number Analyzed 208 participants 211 participants
0
   0.0%
1
   0.5%
3.Primary Outcome
Title Number of Days With Solicited Local Symptoms
Hide Description Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Time Frame During the 7-day (Days 0-6) period after each dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
Overall Number of Participants Analyzed 171 161
Median (Inter-Quartile Range)
Unit of Measure: Days
Any Pain, Dose 1 Number Analyzed 171 participants 159 participants
3.0
(2.0 to 4.0)
2.0
(2.0 to 3.0)
Any Redness, Dose 1 Number Analyzed 69 participants 48 participants
3.0
(2.0 to 4.0)
3.0
(2.0 to 4.0)
Any Swelling, Dose 1 Number Analyzed 29 participants 21 participants
2.0
(2.0 to 3.0)
3.0
(2.0 to 4.0)
Any Pain, Dose 2 Number Analyzed 163 participants 161 participants
2.0
(2.0 to 3.0)
2.0
(2.0 to 3.0)
Any Redness, Dose 2 Number Analyzed 69 participants 53 participants
3.0
(2.0 to 4.0)
3.0
(2.0 to 5.0)
Any Swelling, Dose 2 Number Analyzed 29 participants 27 participants
2.0
(1.0 to 4.0)
2.0
(1.0 to 4.0)
4.Primary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) period after each dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 214
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 215 participants 214 participants
69
  32.1%
59
  27.6%
Grade 3 Fatigue, Dose 1 Number Analyzed 215 participants 214 participants
4
   1.9%
4
   1.9%
Related Fatigue, Dose 1 Number Analyzed 215 participants 214 participants
62
  28.8%
48
  22.4%
Any Gastro. int., Dose 1 Number Analyzed 215 participants 214 participants
31
  14.4%
14
   6.5%
Grade 3 Gastro. int., Dose 1 Number Analyzed 215 participants 214 participants
2
   0.9%
2
   0.9%
Related Gastro. int., Dose 1 Number Analyzed 215 participants 214 participants
24
  11.2%
9
   4.2%
Any Headache, Dose 1 Number Analyzed 215 participants 214 participants
41
  19.1%
44
  20.6%
Grade 3 Headache, Dose 1 Number Analyzed 215 participants 214 participants
4
   1.9%
1
   0.5%
Related Headache, Dose 1 Number Analyzed 215 participants 214 participants
34
  15.8%
34
  15.9%
Any Myalgia, Dose 1 Number Analyzed 215 participants 214 participants
47
  21.9%
42
  19.6%
Grade 3 Myalgia, Dose 1 Number Analyzed 215 participants 214 participants
2
   0.9%
5
   2.3%
Related Myalgia, Dose 1 Number Analyzed 215 participants 214 participants
41
  19.1%
37
  17.3%
Any Shivering, Dose 1 Number Analyzed 215 participants 214 participants
25
  11.6%
17
   7.9%
Grade 3 Shivering, Dose 1 Number Analyzed 215 participants 214 participants
2
   0.9%
1
   0.5%
Related Shivering, Dose 1 Number Analyzed 215 participants 214 participants
22
  10.2%
16
   7.5%
Any Fever, Dose 1 Number Analyzed 215 participants 214 participants
15
   7.0%
17
   7.9%
Grade 3 Fever, Dose 1 Number Analyzed 215 participants 214 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 215 participants 214 participants
12
   5.6%
14
   6.5%
Any Fatigue, Dose 2 Number Analyzed 208 participants 211 participants
91
  43.8%
93
  44.1%
Grade 3 Fatigue, Dose 2 Number Analyzed 208 participants 211 participants
9
   4.3%
11
   5.2%
Related Fatigue, Dose 2 Number Analyzed 208 participants 211 participants
85
  40.9%
84
  39.8%
Any Gastro. int., Dose 2 Number Analyzed 208 participants 211 participants
30
  14.4%
27
  12.8%
Grade 3 Gastro. int., Dose 2 Number Analyzed 208 participants 211 participants
0
   0.0%
0
   0.0%
Related Gastro. int., Dose 2 Number Analyzed 208 participants 211 participants
30
  14.4%
22
  10.4%
Any Headache, Dose 2 Number Analyzed 208 participants 211 participants
62
  29.8%
66
  31.3%
Grade 3 Headache, Dose 2 Number Analyzed 208 participants 211 participants
2
   1.0%
3
   1.4%
Related Headache, Dose 2 Number Analyzed 208 participants 211 participants
57
  27.4%
58
  27.5%
Any Myalgia, Dose 2 Number Analyzed 208 participants 211 participants
61
  29.3%
53
  25.1%
Grade 3 Myalgia, Dose 2 Number Analyzed 208 participants 211 participants
6
   2.9%
5
   2.4%
Related Myalgia, Dose 2 Number Analyzed 208 participants 211 participants
56
  26.9%
51
  24.2%
Any Shivering, Dose 2 Number Analyzed 208 participants 211 participants
36
  17.3%
26
  12.3%
Grade 3 Shivering, Dose 2 Number Analyzed 208 participants 211 participants
4
   1.9%
3
   1.4%
Related Shivering, Dose 2 Number Analyzed 208 participants 211 participants
34
  16.3%
24
  11.4%
Any Fever, Dose 2 Number Analyzed 208 participants 211 participants
26
  12.5%
19
   9.0%
Grade 3 Fever, Dose 2 Number Analyzed 208 participants 211 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 2 Number Analyzed 208 participants 211 participants
24
  11.5%
18
   8.5%
5.Primary Outcome
Title Number of Days With Solicited General Symptoms
Hide Description Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.
Time Frame During the 7-day (Days 0-6) period after each dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
Overall Number of Participants Analyzed 91 93
Median (Inter-Quartile Range)
Unit of Measure: Days
Any Fatigue, Dose 1 Number Analyzed 69 participants 59 participants
1.0
(1.0 to 3.0)
1.0
(1.0 to 3.0)
Any Gastrointestinal symptoms, Dose 1 Number Analyzed 31 participants 14 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Any Headache, Dose 1 Number Analyzed 41 participants 44 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Any Myalgia, Dose 1 Number Analyzed 47 participants 42 participants
2.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
Any Shivering, Dose 1 Number Analyzed 25 participants 17 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 2.0)
Any Temperature, Dose 1 Number Analyzed 15 participants 17 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
Any Fatigue, Dose 2 Number Analyzed 91 participants 93 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 3.0)
Any Gastrointestinal symptoms, Dose 2 Number Analyzed 30 participants 27 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 2.0)
Any Headache, Dose 2 Number Analyzed 62 participants 66 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Any Myalgia, Dose 2 Number Analyzed 61 participants 53 participants
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Any Shivering, Dose 2 Number Analyzed 36 participants 26 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
Any Temperature, Dose 2 Number Analyzed 26 participants 19 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
6.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 30-day (Days 0-29) period after each dose.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 215
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
81
  37.7%
54
  25.1%
Grade 3 AEs
14
   6.5%
5
   2.3%
Related AEs
13
   6.0%
13
   6.0%
7.Primary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time Frame From first vaccination (Month 0) up to 30 days post last vaccination (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 vaccine administration documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 215
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
4
   1.9%
4
   1.9%
Related SAEs
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Hide Description pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame From first vaccination (Month 0) up to 30 days post last vaccination (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 vaccine administration documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 215
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.9%
1
   0.5%
9.Secondary Outcome
Title Anti-gE Ab Concentrations
Hide Description VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Time Frame At Months 0, 1, 3 and 14.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 204 204
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
At Month 0 Number Analyzed 204 participants 202 participants
1784.3
(1572.9 to 2024.1)
1408.5
(1203.3 to 1648.8)
At Month 1 Number Analyzed 204 participants 202 participants
29959.0
(26633.6 to 33699.6)
25233.7
(22072.3 to 28848.0)
At Month 3 Number Analyzed 204 participants 204 participants
49327.2
(45388.2 to 53608.1)
51618.5
(47224.8 to 56420.9)
At Month 14 Number Analyzed 197 participants 199 participants
17783.6
(16077.1 to 19671.4)
15784.1
(14180.2 to 17569.4)
10.Secondary Outcome
Title Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Hide Description gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]), as determined by in vitro Intracellular Cytokine Staining (ICS).
Time Frame At Months 0, 1, 3 and 14.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 177 177
Mean (Standard Deviation)
Unit of Measure: CD4+ T-cells/million T-cells
At Month 0 Number Analyzed 152 participants 140 participants
89.09  (99.73) 90.88  (97.5)
At Month 1 Number Analyzed 177 participants 170 participants
562.17  (532.58) 534.57  (523.97)
At Month 3 Number Analyzed 170 participants 177 participants
2946.02  (2088.48) 2843.89  (2111.54)
At Month 14 Number Analyzed 103 participants 148 participants
1290.98  (1181.89) 1126.44  (1012.28)
11.Secondary Outcome
Title Number of Subjects With Any and Related SAEs
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.
Time Frame From 30 days post last vaccination (Month 3) until study end at Month 14
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 215
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
15
   7.0%
18
   8.4%
Related SAEs
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Subjects With Any pIMDs
Hide Description pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame From 30 days post last vaccination (Month 3) until study end at Month 14
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description:
Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Overall Number of Participants Analyzed 215 215
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.5%
3
   1.4%
Time Frame Solicited local and general AEs were assessed during a 7-day follow-up period (Days 0-6) after each vaccination visit. Unsolicited AEs were assessed for a period of 30 days (Days 0-29) after each vaccination visit. SAEs were assessed from the first receipt of the study vaccine (Month 0) up to study end (Month 14).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1437173A Group Control Group
Hide Arm/Group Description Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study. Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
All-Cause Mortality
GSK1437173A Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/215 (0.93%)      3/215 (1.40%)    
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GSK1437173A Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/215 (8.37%)      22/215 (10.23%)    
Blood and lymphatic system disorders     
Leukocytosis  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Cardiac disorders     
Arrhythmia  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Atrial fibrillation  1  2/215 (0.93%)  2 0/215 (0.00%)  0
Atrioventricular block  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Cardiac arrest  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Coronary artery disease  1  0/215 (0.00%)  0 2/215 (0.93%)  2
Myocardial infarction  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Palpitations  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Pericarditis  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Ventricular fibrillation  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Colitis  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Diarrhoea  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Gastrointestinal disorder  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Gastrooesophageal reflux disease  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Hiatus hernia  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Intestinal obstruction  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Nausea  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Rectal haemorrhage  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Vomiting  1  0/215 (0.00%)  0 1/215 (0.47%)  1
General disorders     
Death  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Non-cardiac chest pain  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Infections and infestations     
Bacterial vaginosis  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Cellulitis  1  2/215 (0.93%)  2 1/215 (0.47%)  1
Diverticulitis  1  1/215 (0.47%)  2 1/215 (0.47%)  1
Paronychia  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Respiratory syncytial virus infection  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Sepsis  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Septic shock  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Injury, poisoning and procedural complications     
Cystitis radiation  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Subdural haematoma  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/215 (0.47%)  1 2/215 (0.93%)  2
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Cervical spinal stenosis  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Spondyloarthropathy  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Adenocarcinoma pancreas  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Basal cell carcinoma  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Breast cancer  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Chronic myeloid leukaemia  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Colon cancer stage iii  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Pancreatic carcinoma  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Plasma cell myeloma  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Prostate cancer  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Squamous cell carcinoma  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Squamous cell carcinoma of skin  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Nervous system disorders     
Cerebrovascular disorder  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Memory impairment  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Myelopathy  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Seizure  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Transient ischaemic attack  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Psychiatric disorders     
Alcohol withdrawal syndrome  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Renal mass  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Pleural effusion  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Pulmonary embolism  1  1/215 (0.47%)  1 0/215 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/215 (0.00%)  0 1/215 (0.47%)  1
Vascular disorders     
Deep vein thrombosis  1  1/215 (0.47%)  1 0/215 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK1437173A Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   199/215 (92.56%)      197/215 (91.63%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  49/215 (22.79%)  61 38/215 (17.67%)  41
General disorders     
Chills  1  51/215 (23.72%)  61 37/215 (17.21%)  44
Fatigue  1  114/215 (53.02%)  162 111/215 (51.63%)  152
Pain  1  189/215 (87.91%)  334 181/215 (84.19%)  321
Pyrexia  1  36/215 (16.74%)  41 32/215 (14.88%)  36
Swelling  1  50/215 (23.26%)  58 37/215 (17.21%)  48
Musculoskeletal and connective tissue disorders     
Myalgia  1  82/215 (38.14%)  109 78/215 (36.28%)  96
Nervous system disorders     
Headache  1  80/215 (37.21%)  105 89/215 (41.40%)  111
Skin and subcutaneous tissue disorders     
Erythema  1  96/215 (44.65%)  138 73/215 (33.95%)  101
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02581410     History of Changes
Other Study ID Numbers: 201198
First Submitted: October 19, 2015
First Posted: October 21, 2015
Results First Submitted: August 29, 2017
Results First Posted: September 26, 2017
Last Update Posted: August 28, 2018