Immunogenicity and Safety Study of GlaxoSmithKline (GSK)... | NCT02581410

Label	Type	Description	Intervention Names
GSK1437173A Group	Experimental	Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.	Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
Control Group	Active Comparator	Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ/su vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.	Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)

Name	Type	Description	Arm Group Labels	Other Names
GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)	Biological	2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.

Measure	Description	Time Frame
Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations	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.	One month after dose 2, at Month 3
Number of Subjects With Solicited Local Symptoms	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.	During the 7-day (Days 0-6) period after each dose.
Number of Days With Solicited Local Symptoms	Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.	During the 7-day (Days 0-6) period after each dose.
Number of Subjects With Solicited General Symptoms	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.	During the 7-day (Days 0-6) period after each dose.
Number of Days With Solicited General Symptoms	Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.

Measure	Description	Time Frame
Anti-gE Ab Concentrations	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).	At Months 0, 1, 3 and 14.
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female ≥ 65 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to performing any study specific procedure.

For the No prev-Zvax group only:

• No previous vaccination with Zostavax.

For the Prev-Zvax group only:

• Previous vaccination with Zostavax ≥ 5 calendar years earlier.

Documentation indicating the date of previous Zostavax vaccination will be required.

Exclusion Criteria:

Previous vaccination with Zostavax < 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax.
Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed.
Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period.
Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine in the period starting 8 days prior to and ending 14 days after either dose of study vaccine.
Current participation in or planned concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study.
History of HZ or any suspected HZ between the screening visit and Visit 1.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period.
Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Huntsville	Alabama	35802	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
32103273	Derived	Dagnew AF, Klein NP, Herve C, Kalema G, Di Paolo E, Peterson J, Salaun B, Schuind A. The Adjuvanted Recombinant Zoster Vaccine in Adults Aged >/=65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine. J Infect Dis. 2021 Oct 13;224(7):1139-1146. doi: 10.1093/infdis/jiaa083.
29029122	Derived

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
201198	Clinical Study Report	View IPD

ID	Title	Description
FG000	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.
FG001	Control Group

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations

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.

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.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

One month after dose 2, at Month 3

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants	OG000204 OG001204

Title

Denominators

Categories

Title	Measurements
	OG00050522.9(44347.4 to 57558.4) OG00148589.4(42649.4 to 55356.6)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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).	ANCOVA				Adjusted GMC ratio	1.04			2-Sided	95	0.92	1.17					Non-Inferiority	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.

Primary

Number of Subjects With Solicited Local Symptoms

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts

Primary

Number of Days With Solicited Local Symptoms

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

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.

Posted

Median

Inter-Quartile Range

Days

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Primary

Number of Subjects With Solicited General Symptoms

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Primary

Number of Days With Solicited General Symptoms

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

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.

Posted

Median

Inter-Quartile Range

Days

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Primary

Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Primary

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Primary

Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Secondary

Anti-gE Ab Concentrations

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).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Months 0, 1, 3 and 14.

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Secondary

Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells

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).

Posted

Mean

Standard Deviation

CD4+ T-cells/million T-cells

At Months 0, 1, 3 and 14.

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts

Secondary

Number of Subjects With Any and Related SAEs

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Secondary

Number of Subjects With Any pIMDs

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK1437173A Group	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.
OG001	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.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected215 at risk EG0010 events0 affected215 at risk
Atrioventricular block	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0012 events2 affected215 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Pericarditis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Death	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected215 at risk EG0011 events1 affected215 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected215 at risk EG0011 events1 affected215 at risk
Paronychia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Septic shock	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0012 events2 affected215 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Colon cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Memory impairment	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Myelopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Renal mass	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected215 at risk EG0011 events1 affected215 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected215 at risk EG0010 events0 affected215 at risk

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	GSK1437173A Group	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK1437173A Group	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.	2	215	18	215	199	215
EG001	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.	3	215	22	215	197	215

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA 20.1	Systematic Assessment	EG00061 events51 affected215 at risk EG00144 events37 affected215 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG000138 events96 affected215 at risk EG001101 events73 affected215 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG000162 events114 affected215 at risk EG001152 events111 affected215 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00061 events49 affected215 at risk EG00141 events38 affected215 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG000105 events80 affected215 at risk EG001111 events89 affected215 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG000109 events82 affected215 at risk EG00196 events78 affected215 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG000334 events189 affected215 at risk EG001321 events181 affected215 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG00041 events36 affected215 at risk EG00136 events32 affected215 at risk
Swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG00058 events50 affected215 at risk EG00148 events37 affected215 at risk