Trial Outcomes & Findings for Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older (NCT NCT02735915)
NCT ID: NCT02735915
Last Updated: 2024-04-12
Results Overview
Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Results posted on
2024-04-12
Participant Flow
Subjects who participated in the parent study Zoster-003 (NCT00434577),in GSK1437173A \_MD Group and received a complete vaccination course(2 doses of 50 µg GSK1437173A) were offered participation in this Long Term Follow-Up study. A total of 70 subjects met the eligibility criteria \& consented to participate in Germany, Sweden and Czech Republic
Out of 70 subjects originally enrolled (Total enrolled cohort for persistence phase) into the study, 8 subjects were eliminated as subject number was allocated without vaccine administration. Only 62 subjects were vaccinated with at least one dose, forming the Total vaccinated cohort(TVc) for re-vaccination phase.
Participant milestones
| Measure |
GSK1437173A Vaccine Group
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
Vaccinated
|
62
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
GSK1437173A Vaccine Group
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
|---|---|
|
Overall Study
Not vaccinated but subject ID assigned
|
8
|
|
Overall Study
Withdrawal following SAE
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
Baseline characteristics by cohort
| Measure |
GSK1437173A Vaccine Group
n=70 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
|---|---|
|
Age, Continuous
|
72.3 Years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European Heritage
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis for persistence at month 108 was performed on the According-to-protocol (ATP) cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=68 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
|
9122.9 mIU/mL
Interval 7775.2 to 10704.1
|
—
|
PRIMARY outcome
Timeframe: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=61 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
|
7384.0 mIU/mL
Interval 6202.8 to 8790.1
|
—
|
PRIMARY outcome
Timeframe: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis for persistence at month 108 was performed on the ATP cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=66 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
|
414.0 CD4 T-cells/million cells
Interval 220.9 to 796.5
|
—
|
PRIMARY outcome
Timeframe: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=57 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
|
401.9 CD4 T-cells/million cells
Interval 298.1 to 901.9
|
—
|
SECONDARY outcome
Timeframe: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the time points considered.
Anti-gE Ab concentrations as determined by ELISA by each age category (60-69 years of age \[YOA\] and ≥70 YOA at the time of initial vaccination).Antibody concentrations were presented as GMCs and expressed in mIU/mL.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=13 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
n=55 Participants
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category
Anti-gE, Month 108
|
8566.4 mIU/mL
Interval 5697.1 to 12880.9
|
9259.6 mIU/mL
Interval 7741.6 to 11075.2
|
|
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category
Anti-gE, Month 120
|
7401.4 mIU/mL
Interval 4894.2 to 11193.1
|
7380.2 mIU/mL
Interval 6048.9 to 9004.4
|
SECONDARY outcome
Timeframe: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the timepoints considered.
Antigen specific CD4 (2+) T-cells as determined by means of ICS and expressed in T-cells/million cells, by each age category (60-69 YOA and ≥ 70 YOA at the time of initial vaccination).
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=13 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
n=53 Participants
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category
CD4(2+), Month 108
|
453.8 CD4 T-cells/million cells
Interval 233.2 to 577.6
|
398.9 CD4 T-cells/million cells
Interval 220.9 to 811.3
|
|
Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category
CD4(2+), Month 120
|
359.2 CD4 T-cells/million cells
Interval 254.9 to 885.0
|
429.4 CD4 T-cells/million cells
Interval 298.1 to 940.1
|
SECONDARY outcome
Timeframe: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).Population: The analysis was performed on the Total enrolled cohort which included all subjects enrolled into the current study \[ZOSTER-060 (NCT02735915)\].
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=70 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).Population: The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered.
Anti-gE antibody concentrations were determined by ELISA in all subjects, presented as GMCs and expressed in mIU/mL.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=54 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Anti-gE Specific Antibody (Ab) Concentrations
Anti-gE, Month 121
|
108199.6 mIU/mL
Interval 87154.2 to 134326.8
|
—
|
|
Anti-gE Specific Antibody (Ab) Concentrations
Anti-gE, Month 123
|
90003.6 mIU/mL
Interval 76754.3 to 105539.9
|
—
|
|
Anti-gE Specific Antibody (Ab) Concentrations
Anti-gE, Month 134
|
30066.2 mIU/mL
Interval 25810.3 to 35023.8
|
—
|
SECONDARY outcome
Timeframe: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).Population: The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered.
Antigen specific CD4 (2+)T cells were determined by means of ICS and expressed in T-cells/million cells.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=50 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
CD4(2+), Month 121
|
2563.9 CD4 T-cells/million cells
Interval 1219.9 to 4127.4
|
—
|
|
Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
CD4(2+), Month 123
|
1775.5 CD4 T-cells/million cells
Interval 1181.4 to 3077.8
|
—
|
|
Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
CD4(2+), Month 134
|
1196.3 CD4 T-cells/million cells
Interval 680.8 to 1850.8
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in.
Assessed solicited local symptoms included: pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = symptoms spreading beyond a surface of (\>) 100 millimeters (mm).
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=62 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain, Dose 1
|
41 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain, Dose 1
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness, Dose 1
|
19 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
>100 mm Redness, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling, Dose 1
|
11 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
>100 mm Swelling, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain, Dose 2
|
26 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness, Dose 2
|
17 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
>100 mm Redness, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling, Dose 2
|
7 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
>100 mm Swelling, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain, Across doses
|
46 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain, Across doses
|
2 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness, Across doses
|
27 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
>100 mm Redness, Across doses
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling, Across doses
|
16 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
> 100 mm Swelling, Across doses
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in.
Assessed solicited general symptoms included: fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and temperature \[higher than or equal to (≥) 37.5 degrees Celsius (°C) for axillary, oral or tympanic route\] and ≥38.0°C for rectal route. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal activity. Grade 3 temperature = defined as fever higher than (\>) 39.0°C, regardless of the route used.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=62 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Dose 2
|
12 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Dose 1
|
25 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Dose 1
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Dose 1
|
25 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Dose 1
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Dose 1
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Dose 1
|
12 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Dose 1
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Dose 1
|
12 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Dose 1
|
20 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Dose 1
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Dose 1
|
19 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Dose 1
|
12 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Dose 1
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Dose 1
|
12 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Dose 1
|
9 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
>39.0°C Temperature, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Dose 1
|
8 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Dose 2
|
15 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Dose 2
|
14 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Dose 2
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Dose 2
|
5 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Dose 2
|
12 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Dose 2
|
15 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Dose 2
|
14 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Dose 2
|
8 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Dose 2
|
8 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Dose 2
|
8 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
>39.0°C Temperature, Dose 2
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Dose 2
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Across doses
|
31 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Across doses
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Across doses
|
31 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Across doses
|
11 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Across doses
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Across doses
|
10 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Across doses
|
18 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Across doses
|
4 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Across doses
|
18 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Across doses
|
29 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Across doses
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Across doses
|
27 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Across doses
|
16 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Across doses
|
4 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Across doses
|
16 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Across doses
|
15 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
>39.0°C Temperature, Across doses
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Across doses
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 30 days (Days 0-29) after each vaccination in the current study.Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.
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 is 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.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=62 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
Any AEs
|
14 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
Any Grade 3 AEs
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
Any Related AEs
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.
SAEs assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=62 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Number of Subjects With Any, Related and Fatal SAEs.
Any SAEs
|
7 Participants
|
—
|
|
Number of Subjects With Any, Related and Fatal SAEs.
Related SAEs
|
0 Participants
|
—
|
|
Number of Subjects With Any, Related and Fatal SAEs.
Any Fatal SAEs
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.
pIMDs assessed includes AEs that were autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Vaccine Group
n=62 Participants
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
GSK1437173A Vaccine ≥ 70 YOA Sub-group
Subjects aged 70 or more than 70 YOA at the time of initial vaccination, who completed vaccination course of 2 doses of HZ/su vaccine (50 µg) in Zoster-003 (NCT00434577) study.
|
|---|---|---|
|
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
Any pIMDs
|
0 Participants
|
—
|
|
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
Related pIMDs
|
0 Participants
|
—
|
Adverse Events
GSK1437173A Vaccine Group
Serious events: 7 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1437173A Vaccine Group
n=62 participants at risk
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Cardiac disorders
Atrial tachycardia
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.6%
1/62 • Number of events 2 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Infections and infestations
Septic shock
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
Other adverse events
| Measure |
GSK1437173A Vaccine Group
n=62 participants at risk
Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
17.7%
11/62 • Number of events 14 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Chills
|
25.8%
16/62 • Number of events 20 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Fatigue
|
50.0%
31/62 • Number of events 40 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Injection site pruritus
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Pain
|
74.2%
46/62 • Number of events 67 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Peripheral swelling
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Pyrexia
|
24.2%
15/62 • Number of events 17 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
General disorders
Swelling
|
25.8%
16/62 • Number of events 18 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Infections and infestations
Cystitis
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Infections and infestations
Oral herpes
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/62 • Number of events 2 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
46.8%
29/62 • Number of events 35 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Nervous system disorders
Headache
|
29.0%
18/62 • Number of events 24 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Skin and subcutaneous tissue disorders
Erythema
|
43.5%
27/62 • Number of events 36 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.6%
1/62 • Number of events 1 • Solicited symptoms: During the 7 day (Day 0-6) post vaccination. Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period; SAEs: From study start (Month 108) up to study end (Month 134).
Reported adverse events data correspond to the total vaccinated cohort for revaccination phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER