Study to Assess the Safety and Immunogenicity of GlaxoSmi... | NCT01767467

NCT01767467

ID	Type	Description	Link
2012-003438-18	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Vaccine Group	Experimental	Subjects will receive the candidate HZ vaccine (GSK 1437173A).	Biological: Herpes zoster vaccine (GSK 1437173A)
Placebo Group	Placebo Comparator	Subjects will receive the placebo vaccine.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Herpes zoster vaccine (GSK 1437173A)	Biological	2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations	Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.	At Month 2
Adjusted Geometric Mean Concentration of Anti-gE Antibodies	The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.	At Month 2
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited Local Symptoms	Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.	Within the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of 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.

Secondary Outcomes

Measure	Description	Time Frame
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations	Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
A male or female, aged 18 years or older at the time of study entry.
Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
Life expectancy greater than or equal to 12 months, as assessed by the investigator.
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled inthe study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.
Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure).
Human immunodeficiency virus (HIV) infection by clinical history.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
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.
Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Inverness	Florida	34452	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40396505	Derived	Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
31399377	Derived	Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macias G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, Lopez-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
FG001	Placebo Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations

Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration.

This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.

The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.

Posted

Number

95% Confidence Interval

Percentage

At Month 2

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants	OG000148 OG001130

Title

Denominators

Categories

Title	Measurements
	OG00080.4(73.1 to 86.5) OG0010.8(0.0 to 4.2)

Primary

Adjusted Geometric Mean Concentration of Anti-gE Antibodies

The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.

The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Month 2

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Primary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. 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 dose administered, who had their symptom sheets completed.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Primary

Number of Days With Solicited Local Symptoms

Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.

Posted

Median

Inter-Quartile Range

Days

Within the 7-day (Days 0-6) post-vaccination period

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants	OG000

Primary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of 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 dose administered, who had their symptom sheets completed.

Posted

Count of Participants

Participants

During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).

Primary

Number of Days With Solicited General Symptoms

Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.

Posted

Median

Inter-Quartile Range

Days

Withing the 7-day (Day 0-6) post-vaccination period

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose)
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose)

Units	Counts
Participants	OG000

Primary

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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. It also included 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 all subjects with at least one vaccine dose administered.

Posted

Count of Participants

Participants

Within the 30-day (Days 0-29) post-vaccination period

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Primary

Number of Subjects With Serious Adverse Events (SAEs)

A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination

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

Posted

Count of Participants

Participants

From first vaccination up to 30 days post last vaccination

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Primary

Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)

Potential immune-mediated diseases (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. Related = pIMds assessed by the investigator as causally related to the study vaccination

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

Posted

Count of Participants

Participants

From first vaccination up to 30 days post last vaccination

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Secondary

Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations

Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.

The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.

Posted

Number

95% Confidence Interval

Percentage

At Month 2

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Secondary

Anti-gE Antibody Concentrations

Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Month 2

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts

Secondary

Time to Occurrence of Any Confirmed HZ Case

Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination.

Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method.

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

Posted

Number

95% Confidence Interval

Person-year rate

From Month 0 until study end (Month 13)

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group

Secondary

Anti-gE Antibody Concentrations

Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.

The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Months 0, 1, 2 and 13

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Secondary

Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations

Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.

Posted

Number

95% Confidence Interval

Percentage

At Months 1, 2 and 13

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Secondary

Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers

Among markers expressed were 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).

The analysis was performed on the adapted ATP cohort for Cell-Mediated Immunogenicity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.

Posted

Mean

Standard Deviation

CD4 [2+] T-cells/million T-cells

At Months 0, 1, 2 and 13

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Secondary

Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers

Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as:

For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells).

For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.

The analysis was performed on the adapted ATP cohort for Cell Mediated Immunity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.

Posted

Number

95% Confidence Interval

Percentage

At Months 1, 2 and 13

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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

Posted

Count of Participants

Participants

From first vaccination at Month 0 up to study end at Month 13

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Secondary

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

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

Posted

Count of Participants

Participants

From first vaccination at Month 0 up to study end at Month 13

ID	Title	Description
OG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
OG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).

Units	Counts
Participants

Secondary

Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies

GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).

This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling.

Posted

Geometric Mean

95% Confidence Interval

mIU/ml

At Months 0 and 2

ID	Title	Description
OG000	GSK1437173A HZ Cases Sub-Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
OG001	GSK1437173A Non-HZ Cases Sub-Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
OG002	Placebo HZ Cases Sub-Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).

Secondary

Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations

MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At Month 2

ID	Title	Description
OG000	GSK1437173A HZ Cases Sub-Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).
OG001	GSK1437173A Non-HZ Cases Sub-Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
OG002	Placebo HZ Cases Sub-Group

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected279 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected279 at risk
Cytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00016 events14 affected283 at risk EG00116 events11 affected279 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected283 at risk EG0012 events2 affected279 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected283 at risk EG0012 events2 affected279 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected283 at risk EG0014 events1 affected279 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected279 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected279 at risk
Myocarditis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected279 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Ophthalmoplegia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Ascites	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected279 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Adhesion	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0012 events2 affected279 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Death neonatal	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Nodule	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected283 at risk EG0013 events3 affected279 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Hepatitis fulminant	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Acute graft versus host disease in skin	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Anaphylactic shock	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Graft versus host disease	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected283 at risk EG0011 events1 affected279 at risk
Graft versus host disease in gastrointestinal tract	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Graft versus host disease in liver	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Aspergillus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected279 at risk
Bacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Bacterial sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected279 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0010 events0 affected279 at risk
Campylobacter colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Chronic sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Corynebacterium bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected279 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Ecthyma	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Epiglottitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected283 at risk EG0010 events0 affected279 at risk
Fungal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Hepatitis b	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected279 at risk
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Infected skin ulcer	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected279 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Meningitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Meningitis aseptic	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Otitis externa	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Otitis media	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Perichondritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00012 events11 affected283 at risk EG00112 events11 affected279 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pneumonia fungal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected283 at risk EG0011 events1 affected279 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pulmonary mycosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pyomyositis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0012 events2 affected279 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected283 at risk EG0016 events6 affected279 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0013 events3 affected279 at risk
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected283 at risk EG0011 events1 affected279 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Systemic candida	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Tooth abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0010 events0 affected279 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Urosepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected279 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0013 events2 affected279 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Oxygen saturation decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0011 events1 affected279 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0018 events8 affected279 at risk
Anaplastic large-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Blastic plasmacytoid dendritic cell neoplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Cervix cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected279 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected283 at risk EG0011 events1 affected279 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0012 events2 affected279 at risk
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0016 events6 affected279 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Precursor t-lymphoblastic lymphoma/leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected279 at risk
T-cell type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Dysarthria	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Loss of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Parkinsonism	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Disorientation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected283 at risk EG0014 events4 affected279 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected279 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected283 at risk EG0012 events2 affected279 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Finger amputation	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Stem cell transplant	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0011 events1 affected279 at risk
Embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0011 events1 affected279 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected283 at risk EG0010 events0 affected279 at risk
Shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected283 at risk EG0012 events2 affected279 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG000101 events76 affected283 at risk EG00140 events29 affected279 at risk
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG00089 events69 affected283 at risk EG00124 events19 affected279 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG000250 events163 affected283 at risk EG001140 events102 affected279 at risk
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG000372 events221 affected283 at risk EG00160 events46 affected279 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG00096 events74 affected283 at risk EG00130 events24 affected279 at risk
Swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG00089 events63 affected283 at risk EG0013 events2 affected279 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG000175 events123 affected283 at risk EG00160 events48 affected279 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG000166 events115 affected283 at risk EG00186 events65 affected279 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG000165 events116 affected283 at risk EG0017 events6 affected279 at risk

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

ID	Term
D019433	Chickenpox Vaccine
D022283	Herpesvirus Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	GSK1437173A Group	Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).
BG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
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 who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	29	283	66	283	252	283
EG001	Placebo Group	Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).	37	279	82	279	146	279