Trial Outcomes & Findings for Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age (NCT NCT02075515)

NCT ID: NCT02075515

Last Updated: 2021-05-14

Results Overview

Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

651 participants

Primary outcome timeframe

At Month 3

Results posted on

2021-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	GSK1437173A Lot A Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Overall Study STARTED	218	217	216
Overall Study COMPLETED	214	212	208
Overall Study NOT COMPLETED	4	5	8

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Lot A Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Overall Study Serious Adverse Event	1	1	1
Overall Study Non-Serious Adverse Event	0	1	0
Overall Study Withdrawal by Subject	2	0	1
Overall Study Lost to Follow-up	1	3	6

Baseline Characteristics

Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Lot A Group n=218 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	Total n=651 Participants Total of all reporting groups
Age, Continuous	64.8 Years STANDARD_DEVIATION 8.8 • n=5 Participants	64.3 Years STANDARD_DEVIATION 9.4 • n=7 Participants	64.4 Years STANDARD_DEVIATION 8.8 • n=5 Participants	64.5 Years STANDARD_DEVIATION 8.99 • n=4 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	130 Participants n=7 Participants	114 Participants n=5 Participants	360 Participants n=4 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	87 Participants n=7 Participants	102 Participants n=5 Participants	291 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Month 3

Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.

Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=210 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=210 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=202 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value	210 Subjects	210 Subjects	202 Subjects

SECONDARY outcome

Timeframe: At Month 0 and Month 3

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.

Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=210 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=210 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=202 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Anti-gE Humoral Immunogenicity Anti-gE, Month 0	1378.4 mIU/mL Interval 1180.0 to 1610.0	1166.5 mIU/mL Interval 1005.5 to 1353.4	1381.2 mIU/mL Interval 1190.9 to 1601.9
Anti-gE Humoral Immunogenicity Anti-gE, Month 3	59556.1 mIU/mL Interval 54587.6 to 64976.7	60733.8 mIU/mL Interval 55995.2 to 65873.3	62058.3 mIU/mL Interval 57422.3 to 67068.7

SECONDARY outcome

Timeframe: At Month 3

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.

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=210 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=210 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=202 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA	201 Subjects	205 Subjects	197 Subjects

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after each vaccine dose and across doses

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=215 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	160 Subjects	179 Subjects	166 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	4 Subjects	6 Subjects	7 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	29 Subjects	48 Subjects	41 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	1 Subjects	1 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	24 Subjects	33 Subjects	26 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	155 Subjects	152 Subjects	155 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	18 Subjects	13 Subjects	7 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	38 Subjects	47 Subjects	43 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	3 Subjects	2 Subjects	2 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	22 Subjects	28 Subjects	25 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	3 Subjects	1 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across Doses	188 Subjects	196 Subjects	185 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	22 Subjects	16 Subjects	13 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across Doses	52 Subjects	68 Subjects	62 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	4 Subjects	3 Subjects	3 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	38 Subjects	44 Subjects	39 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	3 Subjects	1 Subjects	2 Subjects

SECONDARY outcome

Timeframe: During the 7 days (Days 0-6) after each vaccine dose

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

The number of days with any local symptoms reported during the solicited post-vaccination period.

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=215 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Days With Any Solicited Local Symptoms Swelling post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Any Solicited Local Symptoms Pain post-Dose 1	2.0 Days Interval 2.0 to 3.5	3.0 Days Interval 2.0 to 3.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Any Solicited Local Symptoms Pain post-Dose 2	2.0 Days Interval 2.0 to 4.0	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 3.0
Number of Days With Any Solicited Local Symptoms Redness post-Dose 1	2.0 Days Interval 2.0 to 3.0	3.0 Days Interval 1.5 to 3.0	2.0 Days Interval 2.0 to 4.0
Number of Days With Any Solicited Local Symptoms Redness post-Dose 2	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 3.0	3.0 Days Interval 2.0 to 3.0
Number of Days With Any Solicited Local Symptoms Swelling post-Dose 2	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after each vaccine dose and across doses

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

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	66 Subjects	68 Subjects	64 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	5 Subjects	4 Subjects	4 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	62 Subjects	63 Subjects	58 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	23 Subjects	22 Subjects	26 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	1 Subjects	0 Subjects	4 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	19 Subjects	20 Subjects	23 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	63 Subjects	68 Subjects	49 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	5 Subjects	4 Subjects	4 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	59 Subjects	63 Subjects	43 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	85 Subjects	89 Subjects	76 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	4 Subjects	3 Subjects	4 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	71 Subjects	78 Subjects	62 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	31 Subjects	21 Subjects	22 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	1 Subjects	4 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	30 Subjects	19 Subjects	21 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	28 Subjects	23 Subjects	22 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	24 Subjects	21 Subjects	19 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	91 Subjects	85 Subjects	82 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	14 Subjects	7 Subjects	6 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	89 Subjects	80 Subjects	76 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	33 Subjects	34 Subjects	29 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	2 Subjects	2 Subjects	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	29 Subjects	29 Subjects	28 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	74 Subjects	80 Subjects	66 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	9 Subjects	11 Subjects	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	69 Subjects	76 Subjects	63 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	99 Subjects	91 Subjects	83 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	20 Subjects	11 Subjects	7 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	85 Subjects	81 Subjects	76 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	67 Subjects	60 Subjects	44 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	11 Subjects	5 Subjects	7 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	66 Subjects	59 Subjects	43 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	43 Subjects	34 Subjects	25 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	40 Subjects	33 Subjects	25 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across Doses	114 Subjects	109 Subjects	107 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across Doses	18 Subjects	11 Subjects	10 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across Doses	111 Subjects	102 Subjects	103 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across Doses	46 Subjects	45 Subjects	50 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Gastrointestinal,Across Doses	3 Subjects	2 Subjects	9 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across Doses	101 Subjects	108 Subjects	89 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across Doses	13 Subjects	13 Subjects	9 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across Doses	95 Subjects	101 Subjects	82 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across Doses	128 Subjects	119 Subjects	113 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across Doses	24 Subjects	12 Subjects	10 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across Doses	112 Subjects	107 Subjects	102 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across Doses	80 Subjects	67 Subjects	60 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across Doses	12 Subjects	7 Subjects	7 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across Doses	79 Subjects	65 Subjects	58 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across Doses	59 Subjects	49 Subjects	43 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across Doses	2 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across Doses	53 Subjects	46 Subjects	41 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across Doses	41 Subjects	39 Subjects	46 Subjects

SECONDARY outcome

Timeframe: During the 7 days (Days 0-6) after each vaccine dose

The number of days with any general symptoms reported during the solicited post-vaccination period.

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Days With Any Solicited General Symptoms Fatigue post-Dose 1	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Any Solicited General Symptoms Fatigue post-Dose 2	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 2.0
Number of Days With Any Solicited General Symptoms Gastrointestinal symptoms post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Any Solicited General Symptoms Gastrointestinal symptoms post-Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Any Solicited General Symptoms Headache post-Dose 1	1.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Any Solicited General Symptoms Headache post-Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Any Solicited General Symptoms Myalgia post-Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Any Solicited General Symptoms Myalgia post-Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Number of Days With Any Solicited General Symptoms Shivering post-Dose 1	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Number of Days With Any Solicited General Symptoms Shivering post-Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.5	1.0 Days Interval 1.0 to 2.0
Number of Days With Any Solicited General Symptoms Temperature post-Dose 1	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0
Number of Days With Any Solicited General Symptoms Temperature post-Dose 2	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)

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

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=218 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) pIMDs from Month 0 to Month 3	3 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) pIMDs from Month 4 to Month 14	2 Subjects	0 Subjects	2 Subjects

SECONDARY outcome

Timeframe: During 30 days (Days 0-29) after each vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the 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 Lot A Group n=218 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	72 Subjects	69 Subjects	76 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	13 Subjects	15 Subjects	9 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	23 Subjects	22 Subjects	27 Subjects

SECONDARY outcome

Timeframe: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)

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

Outcome measures

Outcome measures
Measure	GSK1437173A Lot A Group n=218 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 Participants Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Number of Subjects With Any Serious Adverse Events (SAEs) SAEs from Month 0 to Month 3	5 Subjects	7 Subjects	4 Subjects
Number of Subjects With Any Serious Adverse Events (SAEs) SAEs from Month 4 to Month 14	10 Subjects	8 Subjects	16 Subjects

Adverse Events

GSK1437173A Lot A Group

Serious events: 13 serious events

Other events: 202 other events

Deaths: 0 deaths

GSK1437173A Lot B Group

Serious events: 14 serious events

Other events: 201 other events

Deaths: 0 deaths

GSK1437173A Lot C Group

Serious events: 20 serious events

Other events: 198 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1437173A Lot A Group n=218 participants at risk Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot B Group n=217 participants at risk Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.	GSK1437173A Lot C Group n=216 participants at risk Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
Gastrointestinal disorders Gastrointestinal disorder	21.1% 46/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	20.7% 45/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	23.1% 50/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
General disorders Chills	36.7% 80/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	30.9% 67/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	28.2% 61/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
General disorders Fatigue	52.3% 114/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	50.2% 109/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	49.5% 107/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
General disorders Pain	86.2% 188/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	90.3% 196/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	85.6% 185/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
General disorders Pyrexia	27.5% 60/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	23.0% 50/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	19.9% 43/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
General disorders Swelling	17.4% 38/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	20.3% 44/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	18.5% 40/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
Infections and infestations Upper respiratory tract infection	3.2% 7/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	3.2% 7/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	5.1% 11/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
Musculoskeletal and connective tissue disorders Myalgia	58.7% 128/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	54.8% 119/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	52.3% 113/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
Nervous system disorders Headache	46.3% 101/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	49.8% 108/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	41.2% 89/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).
Skin and subcutaneous tissue disorders Erythema	25.2% 55/218 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	32.3% 70/217 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).	28.7% 62/216 • Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination; Unsolicited AEs: during 30 days (Days 0-29) after each vaccination; SAEs: from first vaccination up to study end (Month 0-Month 14).

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