Trial Outcomes & Findings for 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 (NCT NCT02581410)

Last Updated: 2018-08-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

430 participants

Primary outcome timeframe

One month after dose 2, at Month 3

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	GSK1437173A Group 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.	Control Group 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.
Vaccination Phase STARTED	215	215
Vaccination Phase COMPLETED	213	212
Vaccination Phase NOT COMPLETED	2	3
End of Study Phase STARTED	215	215
End of Study Phase COMPLETED	210	204
End of Study Phase NOT COMPLETED	5	11

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group 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.	Control Group 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.
Vaccination Phase Adverse Event	2	1
Vaccination Phase Withdrawal by Subject	0	1
Vaccination Phase Migrated/moved from study area	0	1
End of Study Phase Adverse Event	4	3
End of Study Phase Withdrawal by Subject	1	2
End of Study Phase Migrated/moved from study area	0	3
End of Study Phase Lost to Follow-up	0	2
End of Study Phase Other-transfer of subject not completed	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=215 Participants 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 n=430 Participants Total of all reporting groups
Age, Continuous	71.1 Years STANDARD_DEVIATION 4.5 • n=5 Participants	70.8 Years STANDARD_DEVIATION 4.6 • n=7 Participants	70.9 Years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	111 Participants n=7 Participants	220 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	104 Participants n=7 Participants	210 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage · White - Caucasian / European Heritage	215 Participants n=5 Participants	215 Participants n=7 Participants	430 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after dose 2, at Month 3

Population: 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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=204 Participants 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.	Control Group n=204 Participants 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.
Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations	50522.9 mIU/mL Interval 44347.4 to 57558.4	48589.4 mIU/mL Interval 42649.4 to 55356.6

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) period after each dose.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=214 Participants 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.
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 1	171 Participants	159 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 1	8 Participants	7 Participants
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 1	69 Participants	48 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 1	3 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 1	29 Participants	21 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 1	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 2	163 Participants	161 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 2	5 Participants	10 Participants
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 2	69 Participants	53 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 2	6 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 2	29 Participants	27 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	1 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) period after each dose.

Population: 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.

Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=171 Participants 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.	Control Group n=161 Participants 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.
Number of Days With Solicited Local Symptoms Any Pain, Dose 1	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Solicited Local Symptoms Any Redness, Dose 1	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Any Swelling, Dose 1	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms Any Pain, Dose 2	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Solicited Local Symptoms Any Redness, Dose 2	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 5.0
Number of Days With Solicited Local Symptoms Any Swelling, Dose 2	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) period after each dose.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=214 Participants 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.
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 1	69 Participants	59 Participants
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 1	62 Participants	48 Participants
Number of Subjects With Solicited General Symptoms Related Shivering, Dose 1	22 Participants	16 Participants
Number of Subjects With Solicited General Symptoms Related Fever, Dose 1	12 Participants	14 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 1	4 Participants	4 Participants
Number of Subjects With Solicited General Symptoms Any Gastro. int., Dose 1	31 Participants	14 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Gastro. int., Dose 1	2 Participants	2 Participants
Number of Subjects With Solicited General Symptoms Related Gastro. int., Dose 1	24 Participants	9 Participants
Number of Subjects With Solicited General Symptoms Any Headache, Dose 1	41 Participants	44 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 1	4 Participants	1 Participants
Number of Subjects With Solicited General Symptoms Related Headache, Dose 1	34 Participants	34 Participants
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 1	47 Participants	42 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 1	2 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 1	41 Participants	37 Participants
Number of Subjects With Solicited General Symptoms Any Shivering, Dose 1	25 Participants	17 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Shivering, Dose 1	2 Participants	1 Participants
Number of Subjects With Solicited General Symptoms Any Fever, Dose 1	15 Participants	17 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Any Fatigue, Dose 2	91 Participants	93 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue, Dose 2	9 Participants	11 Participants
Number of Subjects With Solicited General Symptoms Related Fatigue, Dose 2	85 Participants	84 Participants
Number of Subjects With Solicited General Symptoms Any Gastro. int., Dose 2	30 Participants	27 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Gastro. int., Dose 2	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Related Gastro. int., Dose 2	30 Participants	22 Participants
Number of Subjects With Solicited General Symptoms Any Headache, Dose 2	62 Participants	66 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Headache, Dose 2	2 Participants	3 Participants
Number of Subjects With Solicited General Symptoms Related Headache, Dose 2	57 Participants	58 Participants
Number of Subjects With Solicited General Symptoms Any Myalgia, Dose 2	61 Participants	53 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia, Dose 2	6 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Related Myalgia, Dose 2	56 Participants	51 Participants
Number of Subjects With Solicited General Symptoms Any Shivering, Dose 2	36 Participants	26 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Shivering, Dose 2	4 Participants	3 Participants
Number of Subjects With Solicited General Symptoms Related Shivering, Dose 2	34 Participants	24 Participants
Number of Subjects With Solicited General Symptoms Any Fever, Dose 2	26 Participants	19 Participants
Number of Subjects With Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Related Fever, Dose 2	24 Participants	18 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) period after each dose.

Population: 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.

Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=91 Participants 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.	Control Group n=93 Participants 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.
Number of Days With Solicited General Symptoms Any Fatigue, Dose 1	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any Gastrointestinal symptoms, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any Headache, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any Myalgia, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any Shivering, Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any Temperature, Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Any Fatigue, Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any Gastrointestinal symptoms, Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any Headache, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any Myalgia, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any Shivering, Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Any Temperature, Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: During the 30-day (Days 0-29) period after each dose.

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=215 Participants 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) Any AEs	81 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) Grade 3 AEs	14 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs) Related AEs	13 Participants	13 Participants

PRIMARY outcome

Timeframe: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=215 Participants 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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Any SAEs	4 Participants	4 Participants
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=215 Participants 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.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: At Months 0, 1, 3 and 14.

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).

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=204 Participants 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.	Control Group n=204 Participants 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.
Anti-gE Ab Concentrations At Month 0	1784.3 mIU/mL Interval 1572.9 to 2024.1	1408.5 mIU/mL Interval 1203.3 to 1648.8
Anti-gE Ab Concentrations At Month 1	29959.0 mIU/mL Interval 26633.6 to 33699.6	25233.7 mIU/mL Interval 22072.3 to 28848.0
Anti-gE Ab Concentrations At Month 3	49327.2 mIU/mL Interval 45388.2 to 53608.1	51618.5 mIU/mL Interval 47224.8 to 56420.9
Anti-gE Ab Concentrations At Month 14	17783.6 mIU/mL Interval 16077.1 to 19671.4	15784.1 mIU/mL Interval 14180.2 to 17569.4

SECONDARY outcome

Timeframe: At Months 0, 1, 3 and 14.

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).

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=177 Participants 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.	Control Group n=177 Participants 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.
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells At Month 0	89.09 CD4+ T-cells/million T-cells Standard Deviation 99.73	90.88 CD4+ T-cells/million T-cells Standard Deviation 97.5
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells At Month 1	562.17 CD4+ T-cells/million T-cells Standard Deviation 532.58	534.57 CD4+ T-cells/million T-cells Standard Deviation 523.97
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells At Month 3	2946.02 CD4+ T-cells/million T-cells Standard Deviation 2088.48	2843.89 CD4+ T-cells/million T-cells Standard Deviation 2111.54
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells At Month 14	1290.98 CD4+ T-cells/million T-cells Standard Deviation 1181.89	1126.44 CD4+ T-cells/million T-cells Standard Deviation 1012.28

SECONDARY outcome

Timeframe: From 30 days post last vaccination (Month 3) until study end at Month 14

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=215 Participants 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.
Number of Subjects With Any and Related SAEs Any SAEs	15 Participants	18 Participants
Number of Subjects With Any and Related SAEs Related SAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 30 days post last vaccination (Month 3) until study end at Month 14

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=215 Participants 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.	Control Group n=215 Participants 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.
Number of Subjects With Any pIMDs	1 Participants	3 Participants

Adverse Events

GSK1437173A Group

Serious events: 18 serious events

Other events: 199 other events

Deaths: 2 deaths

Control Group

Serious events: 22 serious events

Other events: 197 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1437173A Group n=215 participants at risk 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.	Control Group n=215 participants at risk 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.
General disorders Chills	23.7% 51/215 • Number of events 61 • 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).	17.2% 37/215 • Number of events 44 • 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).
Skin and subcutaneous tissue disorders Erythema	44.7% 96/215 • Number of events 138 • 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).	34.0% 73/215 • Number of events 101 • 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).
General disorders Fatigue	53.0% 114/215 • Number of events 162 • 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).	51.6% 111/215 • Number of events 152 • 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).
Gastrointestinal disorders Gastrointestinal disorder	22.8% 49/215 • Number of events 61 • 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).	17.7% 38/215 • Number of events 41 • 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).
Nervous system disorders Headache	37.2% 80/215 • Number of events 105 • 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).	41.4% 89/215 • Number of events 111 • 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).
Musculoskeletal and connective tissue disorders Myalgia	38.1% 82/215 • Number of events 109 • 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).	36.3% 78/215 • Number of events 96 • 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).
General disorders Pain	87.9% 189/215 • Number of events 334 • 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).	84.2% 181/215 • Number of events 321 • 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).
General disorders Pyrexia	16.7% 36/215 • Number of events 41 • 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).	14.9% 32/215 • Number of events 36 • 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).
General disorders Swelling	23.3% 50/215 • Number of events 58 • 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).	17.2% 37/215 • Number of events 48 • 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).

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