Safety & Immunogenicity of GlaxoSmithKline Biologicals' H... | NCT00920218

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GSK 1437173A F1 Group	Experimental	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	Biological: Herpes Zoster Vaccine 1437173A
GSK 1437173A F2 Group	Experimental	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	Biological: Herpes Zoster Vaccine 1437173A
Placebo-GSK 1437173A F1 Group	Experimental	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	Biological: Herpes Zoster Vaccine 1437173A Biological: Placebo vaccine (saline)
Placebo Group	Placebo Comparator	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Herpes Zoster Vaccine 1437173A	Biological	Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.	GSK 1437173A F1 Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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-days (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [including nausea, vomiting, diarrhoea and abdominal pain], temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 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 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.	During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Secondary Outcomes

Measure	Description	Time Frame
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens	The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).	At Months 0, 1, 2, 3, 4 and 15

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
Male and female subjects at least 18 years old at the time of vaccination;
Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;
Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs
Written informed consent obtained from the subject;
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;
Administration of immunoglobulins since transplantation;
Previous vaccination against varicella or HZ;
History of HZ within the previous 12 months;
Known exposure to VZV since transplantation;
Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
Hypersensitivity or intolerance to acyclovir or valacyclovir;
Pregnant or lactating female.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Little Rock	Arkansas	72205	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
25237196	Derived	Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, Mossad SB, Andreadis C, Young JA, Buadi FK, El Idrissi M, Heineman TC, Berkowitz EM. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014 Nov 6;124(19):2921-9. doi: 10.1182/blood-2014-04-573048. Epub 2014 Sep 18.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
BG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
BG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
BG003	Placebo Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
BG004	Total	Total of all reporting groups

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

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 analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	GSK 1437173A 2D Group	Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
OG003	Placebo 1D Group	Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
OG004	Placebo Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Units	Counts
Participants	OG00030 OG00129 OG00228 OG003

Title	Denominators	Categories
Any Pain, Dose 1	ParticipantsOG00030 ParticipantsOG00129 ParticipantsOG00227 ParticipantsOG003

Primary

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [including nausea, vomiting, diarrhoea and abdominal pain], temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Any and Grade 3 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 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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

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

Posted

Count of Participants

Participants

Any time during the study up to Day 29 after the last vaccination

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	GSK 1437173A 2D Group	Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.

Primary

Number of Subjects With Serious Adverse Events (SAEs)

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

Posted

Count of Participants

Participants

During the entire study period (from Day 0 up to Month 15)

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders

Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders

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

Posted

Count of Participants

Participants

During the entire study period (from Day 0 to Month 15)

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

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

Posted

Count of Participants

Participants

At Month 0

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges

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

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges

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

Posted

Count of Participants

Participants

At Month 2

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges

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

Posted

Count of Participants

Participants

At Month 3

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges

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

Posted

Count of Participants

Participants

At Month 4

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Primary

Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines

The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).

The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.

Posted

Mean

Standard Deviation

gE-specific CD4+ T-cells/million T-cells

At Month 4

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group

Primary

Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Month 4

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group

Primary

Anti-gE Mean Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).

Posted

Mean

Standard Deviation

mIU/mL

At Month 4

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Secondary

Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens

Posted

Mean

Standard Deviation

VZV specific CD4+ T-cells/million Tcells

At Months 0, 1, 2, 3, 4 and 15

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group

Secondary

Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines

Posted

Mean

Standard Deviation

gE-specific CD4+ T-cells/million T-cells

At Months 0, 1, 2, 3 and 15

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group

Secondary

Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Months 0, 1, 2, 3, 4 and 15

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Secondary

VZV-specific Mean Antibody Concentrations

Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).

Posted

Mean

Standard Deviation

mIU/mL

At Months 0, 1, 2, 3, 4 and 15

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Secondary

Anti-gE Geometric Mean Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Months 0, 1, 2, 3 and 15

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group

Secondary

Anti-gE Mean Antibody Concentrations

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).

Posted

Mean

Standard Deviation

mIU/mL

At Months 0, 1, 2, 3 and 15

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Secondary

Number of Subjects With Confirmed Herpes Zoster (HZ) Cases

A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study.

he analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the entire study period (from Day 0 to Month 15)

ID	Title	Description
OG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
OG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	3	30	6	30	29	30
EG001	GSK 1437173A F2 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	1	29	9	29	27	29
EG002	Placebo-GSK 1437173A F1 Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	2	31	10	31	29	31
EG003	Placebo Group	Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.	3	30	8	30	21	30

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0021 events1 affected31 at risk EG0030 events0 affected30 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Death	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Disease progression	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Multi-organ failure	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Oedema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003
Sudden death	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Device related infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0022 events2 affected31 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Urosepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Viral infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0022 events2 affected31 at risk EG003
Peripheral t-cell lymphoma unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Convulsion	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0022 events1 affected31 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0012 events2 affected29 at risk EG0020 events0 affected31 at risk EG0031 events1 affected30 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected29 at risk EG0021 events1 affected31 at risk EG003
Blood creatinine increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003
Chills	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0013 events1 affected29 at risk EG0024 events4 affected31 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected30 at risk EG0013 events3 affected29 at risk EG0023 events3 affected31 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected29 at risk EG0021 events1 affected31 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected29 at risk EG0020 events0 affected31 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG00010 events6 affected30 at risk EG00112 events7 affected29 at risk EG00210 events7 affected31 at risk EG003
Fatigue	General disorders	MedDRA 15.0	Systematic Assessment	EG00039 events18 affected30 at risk EG00130 events18 affected29 at risk EG00244 events25 affected31 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00017 events10 affected30 at risk EG00111 events7 affected29 at risk EG00216 events11 affected31 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected29 at risk EG0020 events0 affected31 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00026 events13 affected30 at risk EG0013 events3 affected29 at risk EG00221 events12 affected31 at risk EG003
Hot flush	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0020 events0 affected31 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0013 events2 affected29 at risk EG0021 events1 affected31 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0012 events2 affected29 at risk EG0021 events1 affected31 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00046 events21 affected30 at risk EG00132 events18 affected29 at risk EG00241 events23 affected31 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0004 events3 affected30 at risk EG0011 events1 affected29 at risk EG0022 events2 affected31 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected29 at risk EG0021 events1 affected31 at risk EG003
Oedema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected29 at risk EG0021 events1 affected31 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0006 events5 affected30 at risk EG0011 events1 affected29 at risk EG0021 events1 affected31 at risk EG003
Pain	General disorders	MedDRA 15.0	Systematic Assessment	EG00073 events27 affected30 at risk EG00153 events22 affected29 at risk EG00249 events24 affected31 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0012 events2 affected29 at risk EG0020 events0 affected31 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected29 at risk EG0022 events2 affected31 at risk EG003
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG00019 events12 affected30 at risk EG00111 events9 affected29 at risk EG00217 events12 affected31 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0012 events2 affected29 at risk EG0022 events2 affected31 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0013 events3 affected29 at risk EG0020 events0 affected31 at risk EG003
Swelling	General disorders	MedDRA 15.0	Systematic Assessment	EG0006 events6 affected30 at risk EG0015 events4 affected29 at risk EG0027 events4 affected31 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0012 events2 affected29 at risk EG0020 events0 affected31 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected29 at risk EG0021 events1 affected31 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected29 at risk EG0022 events2 affected31 at risk EG003

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

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds