Trial Outcomes & Findings for Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older (NCT NCT01751165)

NCT ID: NCT01751165

Last Updated: 2018-10-18

Results Overview

Vaccine response was 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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 354 participants
• Primary outcome timeframe: At one month (M1) after Dose 2
• Results posted on: 2018-10-18

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	GSK1437173A-0,2 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.	GSK1437173A-0,6 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Overall Study STARTED	119	119	116
Overall Study COMPLETED	117	116	113
Overall Study NOT COMPLETED	2	3	3

Reasons for withdrawal

Measure	GSK1437173A-0,2 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.	GSK1437173A-0,6 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Overall Study Adverse event, serious fatal	1	0	1
Overall Study Withdrawal by Subject	0	0	1
Overall Study Serious adverse event	0	2	0
Overall Study Lost to Follow-up	1	1	1

Baseline Characteristics

Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older

Baseline characteristics by cohort

Measure	GSK1437173A-0,2 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	Total n=354 Participants Total of all reporting groups
Age, Continuous	64.5 Years STANDARD_DEVIATION 8.9 • n=5 Participants	64 Years STANDARD_DEVIATION 8.6 • n=7 Participants	64.1 Years STANDARD_DEVIATION 9.2 • n=5 Participants	64.2 Years STANDARD_DEVIATION 8.88 • n=4 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	77 Participants n=7 Participants	79 Participants n=5 Participants	246 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	42 Participants n=7 Participants	37 Participants n=5 Participants	108 Participants n=4 Participants

PRIMARY outcome

Timeframe: At one month (M1) after Dose 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.

Vaccine response was 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.

The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=114 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=110 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).	110 Subjects	104 Subjects	—

PRIMARY outcome

Timeframe: At one month (M1) after Dose 2

Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=118 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=114 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=111 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Concentrations of Antibodies Against Anti-gE as Determined by ELISA.	44376.3 mIU/mL Interval 39697.0 to 49607.2	38153.7 mIU/mL Interval 34205.8 to 42557.3	37435.8 mIU/mL Interval 30813.8 to 45480.8

SECONDARY outcome

Timeframe: Prior (PRE) to vaccination and twelve (M12) post Dose 2

Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=118 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=115 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=110 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Concentrations of Antibodies Against Anti-gE as Determined by ELISA. Anti-gE, PRE [N=118,114,110]	1079.1 mIU/mL Interval 891.9 to 1305.5	1066.1 mIU/mL Interval 891.3 to 1275.3	1019.4 mIU/mL Interval 858.6 to 1210.2
Concentrations of Antibodies Against Anti-gE as Determined by ELISA. Anti-gE, M12 [N=117,115,110]	14245.4 mIU/mL Interval 12450.8 to 16298.6	12911.5 mIU/mL Interval 11412.7 to 14607.2	11892.1 mIU/mL Interval 10236.4 to 13815.6

SECONDARY outcome

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

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

Solicited local symptoms assessed include pain, redness and swelling. "Grade 3 pain" was defined as crying when limb was moved/spontaneously painful. "Grade 3 swelling/redness" was defined as swelling/redness larger than (>) 100 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With Solicited Local Symptoms. Any Pain, D1 [N=119,119,115]	84 Subjects	77 Subjects	80 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Pain, D1 [N=119,119,115]	1 Subjects	0 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms. Any Redness, D1 [N=119,119,115]	37 Subjects	39 Subjects	32 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Redness, D1 [N=119,119,115]	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms. Any Swelling, D1 [N=119,119,115]	17 Subjects	23 Subjects	25 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Swelling, D1 [N=119,119,115]	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms. Any Pain, D2 [N=118,117,111]	71 Subjects	83 Subjects	87 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Pain, D2 [N=118,117,111]	6 Subjects	6 Subjects	10 Subjects
Number of Subjects With Solicited Local Symptoms. Any Redness, D2 [N=118,117,111]	28 Subjects	27 Subjects	37 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Redness, D2 [N=118,117,111]	2 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms. Any Swelling, D2 [N=118,117,111]	15 Subjects	9 Subjects	24 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Swelling, D2 [N=118,117,111]	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms. Any Pain, Across [N=119,119,116]	91 Subjects	95 Subjects	98 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Pain, Across [N=119,119,116]	7 Subjects	6 Subjects	12 Subjects
Number of Subjects With Solicited Local Symptoms. Any Redness, Across [N=119,119,116]	48 Subjects	50 Subjects	53 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Redness, Across [N=119,119,116]	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Solicited Local Symptoms. Any Swelling, Across [N=119,119,116]	26 Subjects	28 Subjects	39 Subjects
Number of Subjects With Solicited Local Symptoms. Grade 3 Swelling, Across [N=119,119,116]	0 Subjects	0 Subjects	0 Subjects

SECONDARY outcome

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

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

Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). "Any" = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. "Related" = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. "Grade 3 Fatigue" = fatigue that prevented normal activity. "Grade 3 Gastrointestinal" = gastrointestinal that prevented normal every day activities. "Grade 3 Headache" = headache that prevented normal activity. "Grade 3 Myalgia" = myalgia that prevented normal activity. "Grade 3 Shivering" = shivering that prevented normal activity. "Grade 3 Temperature" = temperature higher than (>) 39.0°C.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With Solicited General Symptoms. Any Fatigue, D1 [N=119,119,115]	42 Subjects	50 Subjects	46 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Fatigue, D1 [N=119,119,115]	3 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms. Related Fatigue, D1 [N=119,119,115]	37 Subjects	49 Subjects	38 Subjects
Number of Subjects With Solicited General Symptoms. Any Gastrointestinal, D1 [N=119,119,115]	22 Subjects	17 Subjects	17 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Gastrointestinal, D1 [N=119,119,115]	3 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms. Related Gastrointestinal, D1 [N=119,119,115]	19 Subjects	14 Subjects	12 Subjects
Number of Subjects With Solicited General Symptoms. Any Headache, D1 [N=119,119,115]	35 Subjects	39 Subjects	34 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Headache, D1 [N=119,119,115]	1 Subjects	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms. Related Headache, D1 [N=119,119,115]	31 Subjects	31 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms. Any Myalgia, D1 [N=119,119,115]	43 Subjects	38 Subjects	46 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Myalgia, D1 [N=119,119,115]	2 Subjects	2 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms. Related Myalgia, D1 [N=119,119,115]	36 Subjects	33 Subjects	40 Subjects
Number of Subjects With Solicited General Symptoms. Any Shivering, D1 [N=119,119,115]	25 Subjects	25 Subjects	29 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Shivering, D1 [N=119,119,115]	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms. Related Shivering, D1 [N=119,119,115]	22 Subjects	22 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms. Any Temperature, D1 [N=119,119,115]	21 Subjects	22 Subjects	14 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Temperature, D1 [N=119,119,115]	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms. Related Temperature, D1 [N=119,119,115]	19 Subjects	21 Subjects	13 Subjects
Number of Subjects With Solicited General Symptoms. Any Fatigue, D2 [N=118,117,111]	43 Subjects	46 Subjects	59 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Fatigue, D2 [N=118,117,111]	4 Subjects	4 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms. Related Fatigue, D2 [N=118,117,111]	41 Subjects	41 Subjects	56 Subjects
Number of Subjects With Solicited General Symptoms. Any Gastrointestinal, D2 [N=118,117,111]	14 Subjects	5 Subjects	12 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Gastrointestinal, D2 [N=118,117,111]	0 Subjects	1 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms. Related Gastrointestinal, D2 [N=118,117,111]	14 Subjects	5 Subjects	10 Subjects
Number of Subjects With Solicited General Symptoms. Any Headache, D2 [N=118,117,111]	36 Subjects	27 Subjects	37 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Headache, D2 [N=118,117,111]	2 Subjects	3 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms. Related Headache, D2 [N=118,117,111]	32 Subjects	22 Subjects	33 Subjects
Number of Subjects With Solicited General Symptoms. Any Myalgia, D2 [N=118,117,111]	48 Subjects	42 Subjects	43 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Myalgia, D2 [N=118,117,111]	5 Subjects	2 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms. Related Myalgia, D2 [N=118,117,111]	46 Subjects	39 Subjects	38 Subjects
Number of Subjects With Solicited General Symptoms. Any Shivering, D2 [N=118,117,111]	25 Subjects	23 Subjects	35 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Shivering, D2 [N=118,117,111]	3 Subjects	3 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms. Related Shivering, D2 [N=118,117,111]	24 Subjects	20 Subjects	31 Subjects
Number of Subjects With Solicited General Symptoms. Any Temperature, D2 [N=118,117,111]	20 Subjects	16 Subjects	26 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Temperature, D2 [N=118,117,111]	0 Subjects	0 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms. Related Temperature, D2 [N=118,117,111]	19 Subjects	16 Subjects	24 Subjects
Number of Subjects With Solicited General Symptoms. Any Fatigue, Across [N=119,119,116]	54 Subjects	63 Subjects	71 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Fatigue, Across [N=119,119,116]	7 Subjects	5 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms. Related Fatigue, Across [N=119,119,116]	49 Subjects	57 Subjects	65 Subjects
Number of Subjects With Solicited General Symptoms. Any Gastrointestinal, Across [N=119,119,116]	27 Subjects	20 Subjects	27 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Gastrointestinal, Across [N=119,119,116]	3 Subjects	2 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms. Related Gastrointestinal, Across [N=119,119,116]	26 Subjects	17 Subjects	21 Subjects
Number of Subjects With Solicited General Symptoms. Any Headache, Across [N=119,119,116]	47 Subjects	47 Subjects	53 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Headache, Across [N=119,119,116]	2 Subjects	4 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms. Related Headache, Across [N=119,119,116]	41 Subjects	38 Subjects	45 Subjects
Number of Subjects With Solicited General Symptoms. Any Myalgia, Across [N=119,119,116]	63 Subjects	57 Subjects	64 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Myalgia, Across [N=119,119,116]	7 Subjects	4 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms. Related Myalgia, Across [N=119,119,116]	57 Subjects	52 Subjects	57 Subjects
Number of Subjects With Solicited General Symptoms. Any Shivering, Across [N=119,119,116]	37 Subjects	35 Subjects	48 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Shivering, Across [N=119,119,116]	4 Subjects	3 Subjects	3 Subjects
Number of Subjects With Solicited General Symptoms. Related Shivering, Across [N=119,119,116]	34 Subjects	29 Subjects	43 Subjects
Number of Subjects With Solicited General Symptoms. Any Temperature, Across [N=119,119,116]	32 Subjects	32 Subjects	33 Subjects
Number of Subjects With Solicited General Symptoms. Grade 3 Temperature, Across [N=119,119,116]	1 Subjects	0 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms. Related Temperature, Across [N=119,119,116]	29 Subjects	31 Subjects	30 Subjects

SECONDARY outcome

Timeframe: During the 30 Days (Day 0-29) following vaccination

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

An adverse event (AE) is 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.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With Unsolicited Adverse Events (AEs). Any AEs	27 Subjects	27 Subjects	23 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs). Grade 3 AEs	4 Subjects	4 Subjects	4 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs). Related AEs	9 Subjects	5 Subjects	7 Subjects

SECONDARY outcome

Timeframe: From first vaccination up to one month (30 Days) post last vaccination

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With Serious Adverse Events (SAEs).	0 Subjects	4 Subjects	8 Subjects

SECONDARY outcome

Timeframe: Starting from 30 Days post last vaccine administration up to study end at Month 24

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With SAE(s).	5 Subjects	6 Subjects	4 Subjects

SECONDARY outcome

Timeframe: During the 7 Days (Day 0-6) following vaccination

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

Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Days With Solicited Local Symptoms. Days with Pain, D1	84 Days	77 Days	80 Days
Number of Days With Solicited Local Symptoms. Days with Pain, D2	71 Days	83 Days	87 Days
Number of Days With Solicited Local Symptoms. Days with Redness, D1	37 Days	39 Days	32 Days
Number of Days With Solicited Local Symptoms. Days with Redness, D2	28 Days	27 Days	37 Days
Number of Days With Solicited Local Symptoms. Days with Swelling, D1	17 Days	23 Days	25 Days
Number of Days With Solicited Local Symptoms. Days with Swelling, D2	15 Days	9 Days	24 Days

SECONDARY outcome

Timeframe: During the 7 Days (Day 0-6) following vaccination

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

Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Days With Solicited General Symptoms. Days with Fatigue, D1	42 Days	50 Days	46 Days
Number of Days With Solicited General Symptoms. Days with Fatigue, D2	43 Days	46 Days	59 Days
Number of Days With Solicited General Symptoms. Days with Gastrointestinal, D1	22 Days	17 Days	17 Days
Number of Days With Solicited General Symptoms. Days with Gastrointestinal, D2	14 Days	5 Days	12 Days
Number of Days With Solicited General Symptoms. Days with Headache, D1	35 Days	39 Days	34 Days
Number of Days With Solicited General Symptoms. Days with Headache, D2	36 Days	27 Days	37 Days
Number of Days With Solicited General Symptoms. Days with Myalgia, D1	43 Days	38 Days	46 Days
Number of Days With Solicited General Symptoms. Days with Myalgia, D2	48 Days	42 Days	43 Days
Number of Days With Solicited General Symptoms. Days with Shivering, D1	25 Days	25 Days	29 Days
Number of Days With Solicited General Symptoms. Days with Shivering, D2	25 Days	23 Days	35 Days
Number of Days With Solicited General Symptoms. Days with Temperature, D1	21 Days	22 Days	14 Days
Number of Days With Solicited General Symptoms. Days with Temperature, D2	20 Days	16 Days	26 Days

SECONDARY outcome

Timeframe: From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)

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

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

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With Potential Immune-mediated Diseases (pIMDs).	0 Subjects	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: From one month (30 Days) following the last vaccine administration up to study end at Month 24

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

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

Outcome measures

Measure	GSK1437173A-0,6 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=119 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.	GSK1437173A-0,12 M Group n=116 Participants Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Number of Subjects With pIMDs.	0 Subjects	0 Subjects	0 Subjects

Adverse Events

GSK1437173A-0,2 M Group

Serious events: 5 serious events

Other events: 107 other events

Deaths: 0 deaths

GSK1437173A-0,6 M Group

Serious events: 9 serious events

Other events: 106 other events

Deaths: 0 deaths

GSK1437173A-0,12 M Group

Serious events: 12 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK1437173A-0,2 M Group n=119 participants at risk Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.	GSK1437173A-0,6 M Group n=119 participants at risk Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=116 participants at risk Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
Blood and lymphatic system disorders Anaemia	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Acute myocardial infarction	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Atrial fibrillation	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Atrial flutter	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Bradycardia	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Cardiovascular disorder	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Coronary artery disease	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Cardiac disorders Ventricular extrasystoles	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Gastrointestinal disorders Diverticulum	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Gastrointestinal disorders Inguinal hernia	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Gastrointestinal disorders Large intestinal stenosis	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Gastrointestinal disorders Mallory-weiss syndrome	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Gastrointestinal disorders Varices oesophageal	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Infections and infestations Helicobacter gastritis	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Injury, poisoning and procedural complications Injury	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Musculoskeletal and connective tissue disorders Arthralgia	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Nervous system disorders Carotid artery disease	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Nervous system disorders Cerebral haemorrhage	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Nervous system disorders Cerebral infarction	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	1.7% 2/119 • Number of events 2 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Psychiatric disorders Psychotic disorder	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Renal and urinary disorders Nephrolithiasis	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Renal and urinary disorders Tubulointerstitial nephritis	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Vascular disorders Hypertension	0.84% 1/119 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/116 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Vascular disorders Venous thrombosis limb	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.00% 0/119 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	0.86% 1/116 • Number of events 1 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).

Other adverse events

Measure	GSK1437173A-0,2 M Group n=119 participants at risk Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.	GSK1437173A-0,6 M Group n=119 participants at risk Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.	GSK1437173A-0,12 M Group n=116 participants at risk Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
General disorders Chills	31.1% 37/119 • Number of events 50 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	29.4% 35/119 • Number of events 48 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	41.4% 48/116 • Number of events 64 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Skin and subcutaneous tissue disorders Erythema	40.3% 48/119 • Number of events 65 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	42.9% 51/119 • Number of events 69 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	45.7% 53/116 • Number of events 69 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
General disorders Fatigue	45.4% 54/119 • Number of events 85 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	52.9% 63/119 • Number of events 98 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	61.2% 71/116 • Number of events 105 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Gastrointestinal disorders Gastrointestinal disorder	22.7% 27/119 • Number of events 36 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	16.8% 20/119 • Number of events 22 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	23.3% 27/116 • Number of events 29 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Nervous system disorders Headache	40.3% 48/119 • Number of events 72 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	40.3% 48/119 • Number of events 68 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	45.7% 53/116 • Number of events 72 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
Musculoskeletal and connective tissue disorders Myalgia	52.9% 63/119 • Number of events 91 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	47.9% 57/119 • Number of events 80 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	55.2% 64/116 • Number of events 89 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
General disorders Pain	76.5% 91/119 • Number of events 155 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	79.8% 95/119 • Number of events 161 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	84.5% 98/116 • Number of events 167 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
General disorders Pyrexia	26.9% 32/119 • Number of events 41 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	26.9% 32/119 • Number of events 38 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	28.4% 33/116 • Number of events 40 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).
General disorders Swelling	21.8% 26/119 • Number of events 32 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	23.5% 28/119 • Number of events 33 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).	33.6% 39/116 • Number of events 49 • Serious Adverse Events were collected during the entire study period (up to Month 24). Other Adverse Events were collected during the 30 Day post-vaccination period (Day 0 - Day 29).

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