Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A (NCT NCT01610414)

Last Updated: 2018-01-23

Results Overview

A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings\* suggestive of VZV infection in the absence of characteristic HZ or VZV rash. A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1877 participants

Primary outcome timeframe

From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)

Results posted on

2018-01-23

Participant Flow

Some of the enrolled subjects were allocated subject numbers, but were not administered all doses of study vaccine, hence they did not start the study.

Participant milestones

Participant milestones
Measure	GSK1437173A Group Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Study Start - Month 13 STARTED	922	924
Study Start - Month 13 COMPLETED	807	795
Study Start - Month 13 NOT COMPLETED	115	129
Month 13 - Month 25 STARTED	922	924
Month 13 - Month 25 COMPLETED	857	854
Month 13 - Month 25 NOT COMPLETED	65	70
After Month 25 STARTED	922	924
After Month 25 COMPLETED	874	871
After Month 25 NOT COMPLETED	48	53

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Study Start - Month 13 Serious Adverse Event	65	67
Study Start - Month 13 Adverse Event	14	14
Study Start - Month 13 Protocol Violation	3	1
Study Start - Month 13 Withdrawal by Subject	23	30
Study Start - Month 13 Migrated/moved from study area	2	4
Study Start - Month 13 Lost to Follow-up	4	6
Study Start - Month 13 Suspected HZ episode	1	3
Study Start - Month 13 Other reasons for withdrawal	3	4
Month 13 - Month 25 Serious Adverse Event	35	38
Month 13 - Month 25 Adverse Event	8	4
Month 13 - Month 25 Withdrawal by Subject	7	8
Month 13 - Month 25 Migrated/moved from study area	4	2
Month 13 - Month 25 Protocol Violation	0	2
Month 13 - Month 25 Lost to Follow-up	5	9
Month 13 - Month 25 Other reasons for withdrawal	6	7
After Month 25 Study end not reached	48	53

Baseline Characteristics

Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=922 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=924 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Total n=1846 Participants Total of all reporting groups
Age, Continuous	54.8 Years STANDARD_DEVIATION 11.7 • n=5 Participants	55.1 Years STANDARD_DEVIATION 11.4 • n=7 Participants	55.0 Years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	342 Participants n=5 Participants	346 Participants n=7 Participants	688 Participants n=5 Participants
Sex: Female, Male Male	580 Participants n=5 Participants	578 Participants n=7 Participants	1158 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage/African American	15 Participants n=5 Participants	25 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian Heritage	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian Heritage	83 Participants n=5 Participants	91 Participants n=7 Participants	174 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese Heritage	43 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian Heritage	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African Heritage	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European Heritage	715 Participants n=5 Participants	712 Participants n=7 Participants	1427 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Mixed Origin	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)

Population: The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=870 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=851 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Confirmed Herpes Zoster (HZ) Episode	49 Participants	135 Participants	—

SECONDARY outcome

Timeframe: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period

Population: The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis, who developed a confirmed case of HZ prior to 1 month after the second vaccination.

Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) \[=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days\].

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=49 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=135 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Duration of 'Worst' HZ-associated Pain	892.0 T (day)	6275.0 T (day)	—

SECONDARY outcome

Timeframe: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)

This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=870 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=851 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Confirmed HZ-associated Complications	3 Participants	13 Participants	—

SECONDARY outcome

Timeframe: From Month 0 until study end (21 months median follow-up)

This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=870 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=851 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Postherpetic Neuralgia (PHN)	1 Participants	9 Participants	—

SECONDARY outcome

Timeframe: At Months 0, 1, 2, 13 and 25

Population: The analysis was performed on the adapted According-to-Protocol (ATP) cohort for humoral immunogenicity, which included data from the ATP cohorts for humoral immunogenicity at Months 0,1,2,13 and 25. The ATP cohort for humoral immunogenicity included all subjects from humoral immunogenicity sub-cohort in ATP cohort for analysis of immunogenicity.

Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=82 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=76 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects Anti-gE, Month 0	762.8 mIU/mL Interval 568.6 to 1023.5	555.0 mIU/mL Interval 404.3 to 761.8	—
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects Anti-gE, Month 1	1844.2 mIU/mL Interval 1282.2 to 2652.4	556.6 mIU/mL Interval 407.3 to 760.6	—
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects Anti-gE, Month 2	12753.2 mIU/mL Interval 7973.0 to 20399.4	443.8 mIU/mL Interval 330.8 to 595.4	—
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects Anti-gE, Month 13	3183.8 mIU/mL Interval 1869.8 to 5421.2	503.6 mIU/mL Interval 307.8 to 824.1	—
Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects Anti-gE, Month 25	2819.0 mIU/mL Interval 1387.1 to 5729.1	527.0 mIU/mL Interval 274.3 to 1012.6	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=901 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=892 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	101 Participants	7 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	1 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	63 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	132 Participants	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	99 Participants	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	168 Participants	9 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	688 Participants	56 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	59 Participants	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	187 Participants	5 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	7 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	638 Participants	45 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	231 Participants	4 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	24 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	12 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	756 Participants	83 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	301 Participants	9 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	28 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	13 Participants	0 Participants	—

SECONDARY outcome

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=901 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=894 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	27 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	395 Participants	212 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	124 Participants	55 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	51 Participants	32 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	340 Participants	170 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	22 Participants	11 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	1 Participants	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	150 Participants	134 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	6 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	170 Participants	50 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	116 Participants	73 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	41 Participants	22 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	6 Participants	6 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	56 Participants	27 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	2 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	60 Participants	28 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	156 Participants	121 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	208 Participants	47 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	210 Participants	79 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across doses	238 Participants	183 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	131 Participants	38 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	356 Participants	282 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	30 Participants	16 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	48 Participants	20 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	153 Participants	41 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	142 Participants	98 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	13 Participants	12 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	51 Participants	13 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	232 Participants	88 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	24 Participants	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Any Headache, Dose 2	95 Participants	20 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	374 Participants	153 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	42 Participants	9 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	185 Participants	59 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	29 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	102 Participants	16 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	150 Participants	28 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	2 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	8 Participants	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	508 Participants	340 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	66 Participants	31 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	18 Participants	17 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across doses	79 Participants	30 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	302 Participants	166 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	26 Participants	10 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	123 Participants	46 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	484 Participants	234 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	56 Participants	19 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	279 Participants	83 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	237 Participants	115 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	35 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	183 Participants	50 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	3 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	101 Participants	15 Participants	—

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=922 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=924 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	60 Participants	47 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	360 Participants	353 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	31 Participants	23 Participants	—

SECONDARY outcome

Timeframe: From Month 0 up to 365 days post last vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=922 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=924 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Any pIMDs	13 Participants	8 Participants	—
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Related pIMDs	3 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.

Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=922 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=924 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Any Relapse	239 Participants	253 Participants	—

SECONDARY outcome

Timeframe: From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=922 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=924 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo Any SAEs, up to Study End	329 Participants	310 Participants	—
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo Any SAEs, up to Month 13	263 Participants	241 Participants	—
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo Related SAEs, up to Month 13	3 Participants	4 Participants	—

SECONDARY outcome

Timeframe: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)

Population: The analysis was performed on the Total Enrolled Cohort.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=932 Participants Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=933 Participants Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	No Group n=3 Participants Subjects who were not assigned to any group (subjects from pre-vaccination visit).
Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination Fatal SAEs	118 Participants	124 Participants	0 Participants
Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination Related SAEs	37 Participants	43 Participants	0 Participants

Adverse Events

GSK1437173A Group

Serious events: 329 serious events

Other events: 813 other events

Deaths: 118 deaths

Placebo Group

Serious events: 310 serious events

Other events: 485 other events

Deaths: 124 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1437173A Group n=922 participants at risk Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.	Placebo Group n=924 participants at risk Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
General disorders Chills	25.8% 238/922 • Number of events 303 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	12.7% 117/924 • Number of events 134 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
Skin and subcutaneous tissue disorders Erythema	33.0% 304/922 • Number of events 422 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	1.2% 11/924 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
General disorders Fatigue	55.2% 509/922 • Number of events 754 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	36.9% 341/924 • Number of events 496 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
Gastrointestinal disorders Gastrointestinal disorder	25.8% 238/922 • Number of events 293 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	20.0% 185/924 • Number of events 235 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
Nervous system disorders Headache	33.0% 304/922 • Number of events 391 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	18.4% 170/924 • Number of events 215 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
Musculoskeletal and connective tissue disorders Myalgia	52.6% 485/922 • Number of events 718 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	25.5% 236/924 • Number of events 327 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
General disorders Pain	82.1% 757/922 • Number of events 1327 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	9.1% 84/924 • Number of events 103 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
General disorders Pyrexia	20.8% 192/922 • Number of events 224 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	6.2% 57/924 • Number of events 66 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
General disorders Swelling	18.2% 168/922 • Number of events 233 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).	0.97% 9/924 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER