Immunogenicity and Safety Study of GSK Biologicals' Herpe... | NCT00802464

ID	Type	Description	Link
2008-005120-86	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GSK1437173A formulation 1 Group	Experimental	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.	Biological: Herpes zoster vaccine GSK1437173A
GSK1437173A formulation 2 Group	Experimental	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) GSK1437173A formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.	Biological: Herpes zoster vaccine GSK1437173A
GSK1437173A formulation 3 Group	Experimental	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/ASO1B and gE/ASO1E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.	Biological: Herpes zoster vaccine GSK1437173A
Control Group	Placebo Comparator	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm on a 0, 2 month schedule.	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Herpes zoster vaccine GSK1437173A	Biological	2 vaccinations at Months 0 and 2 with GSK1437173A (different formulations)	GSK1437173A formulation 1 Group GSK1437173A formulation 2 Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers	The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).	One month after the second vaccination (Month 3)
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers	The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).	One month after the second vaccination (Month 3)
Anti-glycoprotein E (gE) 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).	One month after the second vaccination (Month 3)
Anti-VZV 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).	One month after the second vaccination (Month 3)

Secondary Outcomes

Measure	Description	Time Frame
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers	The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).	At Month 0 and at Month 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female 50 years of age or above at the time of the first vaccination;
Written informed consent obtained from the subject;
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
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 or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
Previous vaccination against HZ;
Previous vaccination against varicella;
History of HZ;
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
Acute disease at the time of enrolment.
Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
History of or current drug and/or alcohol abuse;
Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Phoenix	Arizona	85020	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
23904292	Background	Chlibek R, Bayas JM, Collins H, de la Pinta ML, Ledent E, Mols JF, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013 Dec 15;208(12):1953-61. doi: 10.1093/infdis/jit365. Epub 2013 Jul 31.

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

ID	Type	URL	Comment
112077	Statistical Analysis Plan	View IPD

ID	Title	Description
FG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
FG001	GSK1437173A Formulation 3 Group

Arm/Group Information

ID	Title	Description
BG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
BG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
BG002	GSK1437173A Formulation 2 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
BG003	GSK1437173A Formulation 1 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month 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

Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

Posted

Mean

Standard Deviation

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

One month after the second vaccination (Month 3)

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG003	GSK1437173A Formulation 1 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Units	Counts
Participants	OG00032 OG00170 OG002126 OG003

Title

Denominators

Categories

Title	Measurements
	OG000231.82± 411.84 OG001570.36± 610.10 OG0022172.37± 1805.51 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG003	Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.					Fold increase	5.21			2-Sided	95	3.89	6.98					Other
OG001 OG002

Primary

Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

Posted

Mean

Standard Deviation

VZV-specific CD4+ T-cells/million T-cell

One month after the second vaccination (Month 3)

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Primary

Anti-glycoprotein E (gE) 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

One month after the second vaccination (Month 3)

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group

Primary

Anti-VZV 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

One month after the second vaccination (Month 3)

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group

Secondary

Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

Posted

Mean

Standard Deviation

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

At Month 0 and at Month 2

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers

Posted

Mean

Standard Deviation

VZV-specific CD4+ T-cells/million T-cell

At Month 0 and at Month 2

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Anti-gE 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 0 and at Month 2

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group

Secondary

Anti-VZV 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 0 and at Month 2

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group

Secondary

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 subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group

Secondary

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever [defined as axillary 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 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 subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

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 and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

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 subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

From Month 0 up to Month 8

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.

Posted

Count of Participants

Participants

During the period after Month 8 up to the end of the study at Month 14

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group

Secondary

Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)

Any new onset of autoimmune diseases 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 subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

From Month 0 until Month 8

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002

Secondary

Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)

Posted

Count of Participants

Participants

During the period after Month 8 up to the end of the study at Month 14

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Number of Subjects With Suspected Cases of Herpes Zoster (HZ)

A suspected case of HZ was defined as a rash consistent with HZ.

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

Posted

Count of Participants

Participants

From Month 0 until Month 8

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Number of Subjects With Suspected Cases of Herpes Zoster (HZ)

A suspected case of HZ is defined as a rash consistent with HZ.

Posted

Count of Participants

Participants

During the period after Month 8 up to the end of the study at Month 14

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG002	GSK1437173A Formulation 2 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

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

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

Posted

Count of Participants

Participants

At Month 0

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 1 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

The analyses were performed on the Month 2 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 2 study visit.

Posted

Count of Participants

Participants

At Month 2

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 1 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.

Secondary

Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges

The analyses were performed on the Month 3 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 3 study visit.

Posted

Count of Participants

Participants

At Month 3

ID	Title	Description
OG000	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
OG001	GSK1437173A Formulation 1 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month 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	Placebo Group	Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	0	38	3	38	9	38
EG001	GSK1437173A Formulation 3 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	2	73	8	73	31	73
EG002	GSK1437173A Formulation 2 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	0	149	6	149	114	149
EG003	GSK1437173A Formulation 1 Group	Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	1	150	10	150	131	150

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG0030 events0 affected150 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0021 events1 affected149 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0022 events1 affected149 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0021 events1 affected149 at risk EG003
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Hernia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Appendicitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0021 events1 affected149 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0021 events1 affected149 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected73 at risk EG0021 events1 affected149 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Cerebrovascular disorder	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0021 events1 affected149 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0020 events0 affected149 at risk EG003
Haematoma	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected73 at risk EG0020 events0 affected149 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected73 at risk EG0024 events3 affected149 at risk EG00310 events8 affected150 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0013 events3 affected73 at risk EG00236 events27 affected149 at risk EG003
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG0008 events7 affected38 at risk EG00120 events16 affected73 at risk EG00273 events52 affected149 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0015 events5 affected73 at risk EG00222 events18 affected149 at risk EG003
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0006 events5 affected38 at risk EG00114 events11 affected73 at risk EG00250 events37 affected149 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0003 events2 affected38 at risk EG00116 events12 affected73 at risk EG00269 events49 affected149 at risk EG003
Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected38 at risk EG00117 events14 affected73 at risk EG002171 events104 affected149 at risk EG003
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected73 at risk EG00221 events18 affected149 at risk EG003
Swelling	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0013 events3 affected73 at risk EG00229 events25 affected149 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