Trial Outcomes & Findings for Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers (NCT NCT01767467)

Last Updated: 2018-06-06

Results Overview

Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE \[4x97 milli-international units per milliliter (mIU/mL)\]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

568 participants

Primary outcome timeframe

At Month 2

Results posted on

2018-06-06

Participant Flow

Out of the 568 subjects enrolled, only 562 subjects received vaccination as per protocol and hence started the study.

Participant milestones

Participant milestones
Measure	GSK1437173A Group Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Vaccination Phase (up to Month 2) STARTED	283	279
Vaccination Phase (up to Month 2) COMPLETED	266	259
Vaccination Phase (up to Month 2) NOT COMPLETED	17	20
End of Study Phase (up to Month 13) STARTED	283	279
End of Study Phase (up to Month 13) COMPLETED	236	216
End of Study Phase (up to Month 13) NOT COMPLETED	47	63

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Vaccination Phase (up to Month 2) Adverse Event	8	8
Vaccination Phase (up to Month 2) Protocol Violation	1	0
Vaccination Phase (up to Month 2) Withdrawal by Subject	7	10
Vaccination Phase (up to Month 2) Suspected Herpes Zoster episode	0	1
Vaccination Phase (up to Month 2) Physician Decision	1	0
Vaccination Phase (up to Month 2) Subject unavailable	0	1
End of Study Phase (up to Month 13) Adverse Event	29	39
End of Study Phase (up to Month 13) Protocol Violation	2	0
End of Study Phase (up to Month 13) Withdrawal by Subject	9	14
End of Study Phase (up to Month 13) Migrated/Moved from study area	0	3
End of Study Phase (up to Month 13) Lost to Follow-up	6	4
End of Study Phase (up to Month 13) Suspected Herpes Zoster episode	0	1
End of Study Phase (up to Month 13) Physician Decision	1	0
End of Study Phase (up to Month 13) Subject Unavailable	0	2

Baseline Characteristics

Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).	Total n=562 Participants Total of all reporting groups
Age, Continuous	56.8 Years STANDARD_DEVIATION 15.5 • n=5 Participants	57.8 Years STANDARD_DEVIATION 14.9 • n=7 Participants	57.3 Years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	114 Participants n=7 Participants	228 Participants n=5 Participants
Sex: Female, Male Male	169 Participants n=5 Participants	165 Participants n=7 Participants	334 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage / African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central / South Asian Heritage	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian Heritage	57 Participants n=5 Participants	60 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian Heritage	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic / North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian / European Heritage	198 Participants n=5 Participants	186 Participants n=7 Participants	384 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Missing	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 2

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=148 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=130 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations	80.4 Percentage Interval 73.1 to 86.5	0.8 Percentage Interval 0.0 to 4.2	—	—

PRIMARY outcome

Timeframe: At Month 2

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=148 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=130 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Adjusted Geometric Mean Concentration of Anti-gE Antibodies	22132.9 mIU/mL Interval 16642.8 to 32153.9	777.6 mIU/mL Interval 702.8 to 860.3	—	—

PRIMARY 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 subjects with at least one vaccine dose administered, who had their symptom sheets completed.

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=278 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=274 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	199 Participants	26 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	16 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	80 Participants	1 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	2 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	47 Participants	2 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 Any Pain, Dose 2	172 Participants	31 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	20 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	82 Participants	5 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	10 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	42 Participants	1 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	5 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	221 Participants	45 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	29 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	115 Participants	5 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	12 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	63 Participants	2 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	5 Participants	0 Participants	—	—

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=278 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=271 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Days With Solicited Local Symptoms Pain, Dose 1	3.0 Days Interval 2.0 to 4.0	1.0 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited Local Symptoms Pain, Dose 2	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited Local Symptoms Redness, Dose 1	3.0 Days Interval 2.0 to 5.0	1.0 Days Interval 1.0 to 1.0	—	—
Number of Days With Solicited Local Symptoms Redness, Dose 2	3.0 Days Interval 2.0 to 5.0	4.0 Days Interval 2.0 to 6.0	—	—
Number of Days With Solicited Local Symptoms Swelling, Dose 1	3.0 Days Interval 2.0 to 4.0	1.5 Days Interval 1.0 to 2.0	—	—
Number of Days With Solicited Local Symptoms Swelling, Dose 2	3.0 Days Interval 2.0 to 4.0	4.0 Days Interval 4.0 to 4.0	—	—

PRIMARY 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 subjects with at least one vaccine dose administered, who had their symptom sheets completed.

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=278 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=274 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any fatigue, Dose 1	122 Participants	73 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue, Dose 1	11 Participants	8 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any headache, Dose 1	70 Participants	40 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache, Dose 1	3 Participants	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, Dose 1	37 Participants	11 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal, Dose 1	48 Participants	24 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal, Dose 1	5 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal, Dose 1	13 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related headache, Dose 1	29 Participants	10 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any myalgia, Dose 1	80 Participants	35 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia, Dose 1	11 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related myalgia, Dose 1	33 Participants	10 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any shivering, Dose 1	39 Participants	16 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering, Dose 1	2 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related shivering, Dose 1	14 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related shivering, Dose 2	27 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any temperature, Dose 1	33 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 temperature, Dose 1	0 Participants	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related temperature, Dose 1	18 Participants	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any fatigue, Dose 2	126 Participants	67 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue, Dose 2	16 Participants	6 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, Dose 2	49 Participants	13 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal, Dose 2	53 Participants	16 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal, Dose 2	5 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal, Dose 2	20 Participants	4 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any headache, Dose 2	90 Participants	42 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache, Dose 2	10 Participants	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related headache, Dose 2	42 Participants	9 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any myalgia, Dose 2	93 Participants	25 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia, Dose 2	14 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related myalgia, Dose 2	50 Participants	7 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any shivering, Dose 2	48 Participants	7 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering, Dose 2	9 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any temperature, Dose 2	51 Participants	11 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 teamperature, Dose 2	3 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related temperature, Dose 2	28 Participants	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any fatigue, Across doses	162 Participants	102 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue, Across doses	23 Participants	10 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue, Across doses	63 Participants	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal, Across doses	76 Participants	29 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal, Across doses	9 Participants	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal, Across doses	28 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any headache, Across doses	115 Participants	64 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache, Across doses	12 Participants	6 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related headache, Across doses	52 Participants	16 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any myalgia, Across doses	122 Participants	48 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia, Across doses	22 Participants	5 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related myalgia, Across doses	63 Participants	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any shivering, Across doses	69 Participants	18 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering, Across doses	11 Participants	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related shivering, Across doses	36 Participants	2 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any temperature, Across doses	68 Participants	21 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 teamperature, Across doses	36 Participants	4 Participants	—	—

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=278 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=271 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Days With Solicited General Symptoms Temperature, Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	—	—
Number of Days With Solicited General Symptoms Fatigue, Dose 1	3.0 Days Interval 1.0 to 6.0	3.0 Days Interval 2.0 to 7.0	—	—
Number of Days With Solicited General Symptoms Fatigue, Dose 2	3.0 Days Interval 2.0 to 5.0	3.0 Days Interval 1.0 to 7.0	—	—
Number of Days With Solicited General Symptoms Gastrointestinal symptoms, Dose 1	2.5 Days Interval 1.0 to 5.0	3.5 Days Interval 1.5 to 6.0	—	—
Number of Days With Solicited General Symptoms Gastrointestinal symptoms, Dose 2	2.0 Days Interval 1.0 to 3.0	6.0 Days Interval 2.5 to 7.0	—	—
Number of Days With Solicited General Symptoms Headache, Dose 1	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited General Symptoms Headache, Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0	—	—
Number of Days With Solicited General Symptoms Myalgia, Dose 1	3.5 Days Interval 2.0 to 5.5	3.0 Days Interval 1.0 to 4.0	—	—
Number of Days With Solicited General Symptoms Myalgia, Dose 2	2.0 Days Interval 2.0 to 4.0	3.0 Days Interval 1.0 to 7.0	—	—
Number of Days With Solicited General Symptoms Shivering, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.5	—	—
Number of Days With Solicited General Symptoms Shivering, Dose 2	1.0 Days Interval 1.0 to 2.0	4.0 Days Interval 2.0 to 4.0	—	—
Number of Days With Solicited General Symptoms Temperature, Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	—	—

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all all subjects with at least one vaccine dose 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. It also included any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AEs	134 Participants	128 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AEs	25 Participants	28 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AEs	19 Participants	5 Participants	—	—

PRIMARY outcome

Timeframe: From first vaccination up to 30 days post last vaccination

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects With Serious Adverse Events (SAEs) At least one SAE	17 Participants	29 Participants	—	—
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From first vaccination up to 30 days post last vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose 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. Related = pIMds assessed by the investigator as causally related to the study vaccination

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs) Related pIMDs	0 Participants	0 Participants	—	—
Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs) Any pIMDs	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: At Month 2

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=184 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=165 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations	69.0 Percentage Interval 61.8 to 75.6	0.6 Percentage Interval 0.0 to 3.3	—	—

SECONDARY outcome

Timeframe: At Month 2

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=184 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=165 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Anti-gE Antibody Concentrations	15795.5 mIU/mL Interval 11603.3 to 21502.2	791.6 mIU/mL Interval 648.9 to 965.5	—	—

SECONDARY outcome

Timeframe: From Month 0 until study end (Month 13)

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

Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T\[year)\]). Follow-up period starts Day 1 of vaccination. Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Time to Occurrence of Any Confirmed HZ Case	0.020 Person-year rate Interval 0.009 to 0.045	0.071 Person-year rate Interval 0.045 to 0.111	—	—

SECONDARY outcome

Timeframe: At Months 0, 1, 2 and 13

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=217 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=198 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Anti-gE Antibody Concentrations Anti-gE, Month 0	964.0 mIU/mL Interval 814.5 to 1140.8	883.7 mIU/mL Interval 749.9 to 1041.4	—	—
Anti-gE Antibody Concentrations Anti-gE, Month 1	4216.5 mIU/mL Interval 3328.6 to 5341.4	824.2 mIU/mL Interval 699.4 to 971.3	—	—
Anti-gE Antibody Concentrations Anti-gE, Month 2	13445.6 mIU/mL Interval 10158.9 to 17795.6	832.0 mIU/mL Interval 701.1 to 987.3	—	—
Anti-gE Antibody Concentrations Anti-gE, Month 13	5202.7 mIU/mL Interval 4074.8 to 6642.8	895.4 mIU/mL Interval 734.5 to 1091.5	—	—

SECONDARY outcome

Timeframe: At Months 1, 2 and 13

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=217 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=198 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations VRR, anti-gE, Month 1	44.2 Percentage Interval 37.4 to 51.1	0.0 Percentage Interval 0.0 to 1.9	—	—
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations VRR, anti-gE, Month 2	65.4 Percentage Interval 58.7 to 71.7	0.5 Percentage Interval 0.0 to 2.8	—	—
Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations VRR, anti-gE, Month 13	52.1 Percentage Interval 44.2 to 59.9	3.6 Percentage Interval 1.2 to 8.1	—	—

SECONDARY outcome

Timeframe: At Months 0, 1, 2 and 13

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

Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=58 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=51 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers CD4 [2+], Month 0	226.78 CD4 [2+] T-cells/million T-cells Standard Deviation 659.84	147.30 CD4 [2+] T-cells/million T-cells Standard Deviation 191.91	—	—
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers CD4 [2+], Month 1	1261.67 CD4 [2+] T-cells/million T-cells Standard Deviation 2318.36	196.74 CD4 [2+] T-cells/million T-cells Standard Deviation 332.52	—	—
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers CD4 [2+], Month 2	6083.98 CD4 [2+] T-cells/million T-cells Standard Deviation 10467.57	318.20 CD4 [2+] T-cells/million T-cells Standard Deviation 1000.90	—	—
Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers CD4 [2+], Month 13	3626.87 CD4 [2+] T-cells/million T-cells Standard Deviation 7758.18	181.23 CD4 [2+] T-cells/million T-cells Standard Deviation 387.90	—	—

SECONDARY outcome

Timeframe: At Months 1, 2 and 13

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

Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x\<320\> Events/106 CD4+ T cells). For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=48 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=47 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers CD4 [2+], Month 1	37.5 Percentage Interval 24.0 to 52.6	2.1 Percentage Interval 0.1 to 11.3	—	—
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers CD4 [2+], Month 2	83.7 Percentage Interval 69.3 to 93.2	6.8 Percentage Interval 1.4 to 18.7	—	—
Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers CD4 [2+], Month 13	66.7 Percentage Interval 48.2 to 82.0	6.5 Percentage Interval 0.8 to 21.4	—	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects With Serious Adverse Events (SAEs) At least one SAE, up to Month 6	50 Participants	60 Participants	—	—
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs, up to Month 6	0 Participants	1 Participants	—	—
Number of Subjects With Serious Adverse Events (SAEs) At least one SAE, up to Month 13	66 Participants	82 Participants	—	—
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs, up to Month 13	1 Participants	1 Participants	—	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=283 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) Up to Month 6	3 Participants	1 Participants	—	—
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) Up to Month 13	3 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: At Months 0 and 2

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=2 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=257 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group n=12 Participants Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group n=240 Participants Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies Month 2	184.0 mIU/ml Interval 0.0 to 4187800000.0	12517.4 mIU/ml Interval 9662.0 to 16216.6	960.5 mIU/ml Interval 454.2 to 2031.1	802.9 mIU/ml Interval 686.7 to 938.9
Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies PRE	115.9 mIU/ml Interval 0.0 to 7406196.0	973.6 mIU/ml Interval 835.6 to 1134.4	984.5 mIU/ml Interval 500.7 to 1935.7	866.3 mIU/ml Interval 745.5 to 1006.6

SECONDARY outcome

Timeframe: At Month 2

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=2 Participants Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=253 Participants Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of placebo could be administered 1 - 2 months after the first dose).	Placebo HZ Cases Sub-Group n=12 Participants Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with confirmed Herpes Zoster (HZ).	Placebo Non-HZ Cases Sub-Group n=233 Participants Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose), with non-confirmed Herpes Zoster (HZ).
Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations	1.59 Ratio Interval 0.0 to 565.45	13.07 Ratio Interval 9.93 to 17.22	0.98 Ratio Interval 0.8 to 1.19	0.94 Ratio Interval 0.88 to 1.0

Adverse Events

GSK1437173A Group

Serious events: 66 serious events

Other events: 252 other events

Deaths: 29 deaths

Placebo Group

Serious events: 82 serious events

Other events: 146 other events

Deaths: 37 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1437173A Group n=283 participants at risk Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine could be administered 1 - 2 months after the first dose).	Placebo Group n=279 participants at risk Subjects who received placebo doses according to a 0, 1 Months schedule (The second dose of placebo could be administered 1 - 2 months after the first dose).
Gastrointestinal disorders Gastrointestinal disorder	26.9% 76/283 • Number of events 101 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	10.4% 29/279 • Number of events 40 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
General disorders Chills	24.4% 69/283 • Number of events 89 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	6.8% 19/279 • Number of events 24 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
General disorders Fatigue	57.6% 163/283 • Number of events 250 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	36.6% 102/279 • Number of events 140 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
General disorders Pain	78.1% 221/283 • Number of events 372 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	16.5% 46/279 • Number of events 60 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
General disorders Pyrexia	26.1% 74/283 • Number of events 96 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	8.6% 24/279 • Number of events 30 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
General disorders Swelling	22.3% 63/283 • Number of events 89 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	0.72% 2/279 • Number of events 3 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
Musculoskeletal and connective tissue disorders Myalgia	43.5% 123/283 • Number of events 175 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	17.2% 48/279 • Number of events 60 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
Nervous system disorders Headache	40.6% 115/283 • Number of events 166 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	23.3% 65/279 • Number of events 86 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.
Skin and subcutaneous tissue disorders Erythema	41.0% 116/283 • Number of events 165 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.	2.2% 6/279 • Number of events 7 • Solicited and unsolicited symptoms: within the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end, at Month 13.

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