Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy (NCT NCT01798056)

Last Updated: 2021-05-13

Results Overview

Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

237 participants

Primary outcome timeframe

At Month 2

Results posted on

2021-05-13

Participant Flow

Out of the 237 subjects initially enrolled in the study, only 232 subject were included in the Total Vaccinated Cohort.

Participant milestones

Participant milestones
Measure	GSK1437173A Group Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placebo Group Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Overall Study STARTED	117	115
Overall Study COMPLETED	90	90
Overall Study NOT COMPLETED	27	25

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placebo Group Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Overall Study Serious Adverse Event	13	12
Overall Study Withdrawal by Subject	12	9
Overall Study Migrated/moved from study area	1	1
Overall Study Lost to Follow-up	1	1
Overall Study Other	0	2

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=117 Participants Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placebo Group n=115 Participants Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Total n=232 Participants Total of all reporting groups
Age, Continuous	57.1 Years STANDARD_DEVIATION 10.8 • n=5 Participants	58.5 Years STANDARD_DEVIATION 11.7 • n=7 Participants	57.79 Years STANDARD_DEVIATION 11.25 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage/African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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 - East Asian Heritage	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian Heritage	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European Heritage	92 Participants n=5 Participants	88 Participants n=7 Participants	180 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Mixed Origin	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Missing	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 2

Population: The analysis was performed on the PreChemo groups from the According-to-Protocol (ATP) cohort for Humoral immunogenicity which included all evaluable subjects up to 30 days post last vaccination and who had met all eligibility criteria and complied with the procedures and intervals defined in the protocol for active phase of the study.

Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=65 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=76 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups	24501.57 EL.U/mL Interval 19051.99 to 31509.94	1056.77 EL.U/mL Interval 990.37 to 1127.62

PRIMARY outcome

Timeframe: At Month 2

Population: The analysis was performed on the ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time point Month 2 data were obtained from the ATP cohort for Humoral Immunogenicity.

Antibody concentrations as determined by ELISA are 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-PreChemo n=87 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=98 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations	18291.7 mIU/mL Interval 14432.1 to 23183.5	1060.5 mIU/mL Interval 873.9 to 1287.1

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 dose of study vaccine administered, who had their symptom sheets filled in.

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 every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=112 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=110 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	83 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	8 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	33 Participants	0 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	15 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	52 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	4 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	20 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	8 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	90 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	11 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	40 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	18 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	0 Participants

PRIMARY outcome

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

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

The number of days with any local symptoms has been assessed during the post-vaccination period.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=83 Doses with the symptom Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=5 Doses with the symptom Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Days With Solicited Local Symptoms Swelling, Dose 2	3.5 Days Interval 2.0 to 5.5	—
Number of Days With Solicited Local Symptoms Pain, Dose 1	2.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited Local Symptoms Pain, Dose 2	2.0 Days Interval 1.0 to 3.5	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Local Symptoms Redness, Dose 1	3.0 Days Interval 2.0 to 5.0	—
Number of Days With Solicited Local Symptoms Redness, Dose 2	4.0 Days Interval 2.0 to 5.0	—
Number of Days With Solicited Local Symptoms Swelling, Dose 1	4.0 Days Interval 2.0 to 5.0	7.0 Days Interval 7.0 to 7.0

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 dose of study vaccine administered, who had their symptom sheets filled in.

Assessed solicited general symptoms were fatigue, gastrointestinal \[symptoms included nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and fever \[defined as oral, axillary or tympanic temperature equal to or above 37.5 degrees Celsius (°C)\]. 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-PreChemo n=112 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=110 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	56 Participants	44 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	15 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	32 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	2 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	9 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	28 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	10 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	25 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	27 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	5 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	12 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	13 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	11 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	57 Participants	57 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	9 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	5 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	6 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	29 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	7 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	32 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	4 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	13 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	20 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	6 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	8 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	4 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	78 Participants	68 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	16 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	19 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across doses	51 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	6 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	16 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	60 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	12 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	30 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	39 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	6 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	16 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	20 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	14 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	10 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	50 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	8 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	6 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	41 Participants	39 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	6 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across doses	11 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	43 Participants	40 Participants

PRIMARY outcome

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

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

The number of days with any general symptoms has been assessed during the post-vaccination period.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=57 Doses with the symptom Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=57 Doses with the symptom Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Days With Solicited General Symptoms Fatigue, Dose 1	3.0 Days Interval 1.5 to 6.0	5.0 Days Interval 2.0 to 6.0
Number of Days With Solicited General Symptoms Gastrointestinal symptoms, Dose 1	2.5 Days Interval 1.5 to 4.0	4.0 Days Interval 2.0 to 6.0
Number of Days With Solicited General Symptoms Gastrointestinal symptoms, Dose 2	4.0 Days Interval 3.0 to 7.0	3.0 Days Interval 2.0 to 7.0
Number of Days With Solicited General Symptoms Headache, Dose 1	2.0 Days Interval 1.0 to 3.5	2.0 Days Interval 1.5 to 4.5
Number of Days With Solicited General Symptoms Headache, Dose 2	2.0 Days Interval 2.0 to 6.0	2.0 Days Interval 1.0 to 5.0
Number of Days With Solicited General Symptoms Myalgia, Dose 1	2.5 Days Interval 1.0 to 4.0	2.0 Days Interval 2.0 to 6.0
Number of Days With Solicited General Symptoms Myalgia, Dose 2	3.0 Days Interval 2.0 to 5.5	5.0 Days Interval 3.0 to 7.0
Number of Days With Solicited General Symptoms Shivering, Dose 2	3.0 Days Interval 1.0 to 6.0	2.0 Days Interval 1.0 to 4.0
Number of Days With Solicited General Symptoms Temperature, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Temperature, Dose 2	1.5 Days Interval 1.0 to 2.5	1.0 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Fatigue, Dose 2	5.0 Days Interval 2.0 to 7.0	5.0 Days Interval 3.0 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 2.0

PRIMARY 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 subjects with at least one dose of study vaccine 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-PreChemo n=117 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=115 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	100 Participants	103 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	10 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	18 Participants	15 Participants

PRIMARY outcome

Timeframe: From first dose 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 dose of study vaccine administered.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=117 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=115 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Serious Adverse Events (SAEs) Any SAEs	16 Participants	14 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 dose of study vaccine 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-PreChemo n=117 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=115 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Any pIMDs	0 Participants	0 Participants
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Related pIMDs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Months 0, 1, 6 and 13

Population: The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=87 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=97 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Anti-VZV gE Antibody Concentrations Anti-VZV gE, Month 0	1049.8 mIU/mL Interval 865.8 to 1273.0	1116.7 mIU/mL Interval 918.4 to 1358.0
Anti-VZV gE Antibody Concentrations Anti-VZV gE, Month 1	24793.1 mIU/mL Interval 18747.8 to 32787.6	1107.2 mIU/mL Interval 920.0 to 1332.6
Anti-VZV gE Antibody Concentrations Anti-VZV gE, Month 6	7730.4 mIU/mL Interval 5358.4 to 11152.2	1380.2 mIU/mL Interval 1066.3 to 1786.6
Anti-VZV gE Antibody Concentrations Anti-VZV gE, Month 13	4477.3 mIU/mL Interval 3482.4 to 5756.3	1064.7 mIU/mL Interval 845.9 to 1340.1

SECONDARY outcome

Timeframe: At Months 1, 2, 6 and 13

Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/ml); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=87 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=94 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations Vaccine responders Month 1	73 Participants	0 Participants
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations Vaccine responders Month 2	75 Participants	0 Participants
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations Vaccine responders Month 6	31 Participants	1 Participants
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations Vaccine responders Month 13	35 Participants	0 Participants

SECONDARY outcome

Timeframe: At Months 0, 1, 2 and 13

Population: The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.

Descriptive statistics were tabulated for CD4\[2+\] cells, which are gE specific CD4+ T-cells with at least two activation markers (\[2+\]), expressed from the activation markers interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40-ligand (CD40-L), as determined by intracellular cytokine staining (ICS) method.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=25 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=30 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 0	127.3 CD4 T-cells/million T-cells Interval 49.7 to 192.4	104.8 CD4 T-cells/million T-cells Interval 27.5 to 151.5
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 1	391.9 CD4 T-cells/million T-cells Interval 139.7 to 603.7	50.0 CD4 T-cells/million T-cells Interval 1.0 to 179.4
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 2	778.8 CD4 T-cells/million T-cells Interval 393.1 to 1098.2	61.8 CD4 T-cells/million T-cells Interval 17.4 to 139.5
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 13	332.9 CD4 T-cells/million T-cells Interval 114.9 to 604.6	51.2 CD4 T-cells/million T-cells Interval 1.0 to 288.6

SECONDARY outcome

Timeframe: At Months 1, 2 and 13

Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive 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-PreChemo n=25 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=27 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 1	5 Participants	0 Participants
Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 2	11 Participants	0 Participants
Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups CD4[2+] T-cells, Month 13	3 Participants	0 Participants

SECONDARY outcome

Timeframe: From 30 days post last vaccination up to study end (Month 13)

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=117 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=115 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Serious Adverse Events (SAEs) Any SAEs	30 Participants	31 Participants
Number of Subjects With Serious Adverse Events (SAEs) Related SAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 30 days post last vaccination up to study end (Month 13)

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

Outcome measures

Outcome measures
Measure	GSK1437173A-PreChemo n=117 Participants Subjects receiving the adjuvanted GSK1437173A vaccine, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placeb-PreChemo n=115 Participants Subjects receiving saline placebo, with the first vaccination at least 10 days (up to 1 month) before the start of a chemotherapy cycle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)	0 Participants	1 Participants

Adverse Events

GSK1437173A Group

Serious events: 36 serious events

Other events: 113 other events

Deaths: 12 deaths

Placebo Group

Serious events: 42 serious events

Other events: 103 other events

Deaths: 11 deaths

Serious adverse events

Other adverse events

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

Measure	GSK1437173A Group n=117 participants at risk Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.	Placebo Group n=115 participants at risk Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Skin and subcutaneous tissue disorders Alopecia	17.9% 21/117 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	20.0% 23/115 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Asthenia	25.6% 30/117 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	24.3% 28/115 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Chills	33.3% 39/117 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	21.7% 25/115 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Gastrointestinal disorders Constipation	13.7% 16/117 • Number of events 19 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	9.6% 11/115 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Metabolism and nutrition disorders Decreased appetite	7.7% 9/117 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	4.3% 5/115 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Gastrointestinal disorders Diarrhoea	7.7% 9/117 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	8.7% 10/115 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Nervous system disorders Dysgeusia	0.85% 1/117 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	5.2% 6/115 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Gastrointestinal disorders Dyspepsia	5.1% 6/117 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	11.3% 13/115 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Skin and subcutaneous tissue disorders Erythema	36.8% 43/117 • Number of events 58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Fatigue	68.4% 80/117 • Number of events 118 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	60.0% 69/115 • Number of events 109 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Gastrointestinal disorders Gastrointestinal disorder	43.6% 51/117 • Number of events 74 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	44.3% 51/115 • Number of events 63 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Nervous system disorders Headache	38.5% 45/117 • Number of events 61 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	35.7% 41/115 • Number of events 52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Mucosal inflammation	7.7% 9/117 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	5.2% 6/115 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Musculoskeletal and connective tissue disorders Myalgia	53.0% 62/117 • Number of events 88 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	28.7% 33/115 • Number of events 45 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Gastrointestinal disorders Nausea	26.5% 31/117 • Number of events 36 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	24.3% 28/115 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Blood and lymphatic system disorders Neutropenia	9.4% 11/117 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	12.2% 14/115 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Pain	76.9% 90/117 • Number of events 139 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	6.1% 7/115 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Pyrexia	18.8% 22/117 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	7.8% 9/115 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
General disorders Swelling	15.4% 18/117 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).
Gastrointestinal disorders Vomiting	8.5% 10/117 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).	12.2% 14/115 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from first dose up to study end (Month 13).