Trial Outcomes & Findings for Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age (NCT NCT02979639)

Last Updated: 2019-10-08

Results Overview

Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

404 participants

Primary outcome timeframe

From Baseline at Day -7 to Day 8 after first dose

Results posted on

2019-10-08

Participant Flow

A total of 404 subjects were enrolled in the study. However,1 subject was considered not eligible per the exclusion criteria (had previously received a Zoster vaccine) \& 2 subjects were not vaccinated due to voluntary consent withdrawal.Hence,401 subjects were considered to have started the study \& administered the first study vaccine (Exposed Set)

Participant milestones

Participant milestones
Measure	GSK1437173A Group Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Overall Study STARTED	401
Overall Study COMPLETED	387
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Overall Study Withdrawal based on medical judgement	1
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2

Baseline Characteristics

Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=401 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Age, Continuous	64.6 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	235 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage/African American	48 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	7 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	332 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline at Day -7 to Day 8 after first dose

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=400 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose	1.9 Score units Standard Deviation 10.44

SECONDARY outcome

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

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

Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=389 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose	-0.4 Score units Standard Deviation 10.38

SECONDARY outcome

Timeframe: From Baseline at Day -7 to Day 8 after first dose

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

Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=400 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in Mean SF-36 PF Single Item Scores After First Dose Vigorous activites	6.8 Score units Standard Deviation 26.26
Change in Mean SF-36 PF Single Item Scores After First Dose Moderate activites	1.5 Score units Standard Deviation 16.76
Change in Mean SF-36 PF Single Item Scores After First Dose Lifting or carrying groceries	1.5 Score units Standard Deviation 13.84
Change in Mean SF-36 PF Single Item Scores After First Dose Climbing several flights	0.7 Score units Standard Deviation 17.77
Change in Mean SF-36 PF Single Item Scores After First Dose Climbing one flight	0.5 Score units Standard Deviation 16.26
Change in Mean SF-36 PF Single Item Scores After First Dose Bending, kneeling or stooping	5.8 Score units Standard Deviation 19.86
Change in Mean SF-36 PF Single Item Scores After First Dose Walking more than a mile	-0.2 Score units Standard Deviation 19.28
Change in Mean SF-36 PF Single Item Scores After First Dose Walking several hundred yards	-0.1 Score units Standard Deviation 16.66
Change in Mean SF-36 PF Single Item Scores After First Dose Walking one hundred yards	1.8 Score units Standard Deviation 15.11
Change in Mean SF-36 PF Single Item Scores After First Dose Bathing or dressing himself/herself	0.9 Score units Standard Deviation 11.35

SECONDARY outcome

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

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

Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=389 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in Mean SF-36 PF Single Item Scores After Second Dose Walking several 100 yards	-2.0 Score units Standard Deviation 15.30
Change in Mean SF-36 PF Single Item Scores After Second Dose Climbing one flight	-1.6 Score units Standard Deviation 16.09
Change in Mean SF-36 PF Single Item Scores After Second Dose Walking 100 Yards	-0.1 Score units Standard Deviation 13.48
Change in Mean SF-36 PF Single Item Scores After Second Dose Bathing/dressing self	1.0 Score units Standard Deviation 12.01
Change in Mean SF-36 PF Single Item Scores After Second Dose Bending or kneeling	3.9 Score units Standard Deviation 19.32
Change in Mean SF-36 PF Single Item Scores After Second Dose Walking more than mile	-2.3 Score units Standard Deviation 17.77
Change in Mean SF-36 PF Single Item Scores After Second Dose Vigorous activities	2.6 Score units Standard Deviation 22.58
Change in Mean SF-36 PF Single Item Scores After Second Dose Moderate activities	-1.2 Score units Standard Deviation 16.82
Change in Mean SF-36 PF Single Item Scores After Second Dose Carrying groceries	-0.2 Score units Standard Deviation 13.05
Change in Mean SF-36 PF Single Item Scores After Second Dose Climbing several flights	-3.7 Score units Standard Deviation 18.76

SECONDARY outcome

Timeframe: From Baseline at Day -7 to Day 8 after first dose

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

Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=286 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in SF-36 Role Physical Scores After First Dose	1.4 Score units Standard Deviation 14.97

SECONDARY outcome

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

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

Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=291 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in SF-36 Role Physical Scores After Second Dose	-1.8 Score units Standard Deviation 16.40

SECONDARY outcome

Timeframe: From Baseline at Day -7 to Day 8 after first dose

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

Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=399 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in Quality-adjusted Life Year (QALY) After First Dose	0.1829 Score units Standard Deviation 0.55551

SECONDARY outcome

Timeframe: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)

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

Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life).

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=388 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Change in QALY After Second Dose	0.1128 Score units Standard Deviation 0.52000

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after first dose

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

Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=401 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Reactogenicity-triggered Medically Attended Visits After First Dose Attended by Telephone Call	2 Visits
Number of Reactogenicity-triggered Medically Attended Visits After First Dose Attended by General Practicioner	1 Visits
Number of Reactogenicity-triggered Medically Attended Visits After First Dose Attended by Specialist	0 Visits
Number of Reactogenicity-triggered Medically Attended Visits After First Dose Attended by Emergency Room	0 Visits
Number of Reactogenicity-triggered Medically Attended Visits After First Dose Attended by Hospitalization	0 Visits

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after second dose

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=391 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Reactogenicity-triggered Medically Attended Visits After Second Dose Attended by Telephone Call	4 Visits
Number of Reactogenicity-triggered Medically Attended Visits After Second Dose Attended by General Practitioner	1 Visits
Number of Reactogenicity-triggered Medically Attended Visits After Second Dose Attended by Specialist	0 Visits
Number of Reactogenicity-triggered Medically Attended Visits After Second Dose Attended by Emergency Room	0 Visits
Number of Reactogenicity-triggered Medically Attended Visits After Second Dose Attended by Hospitalization	0 Visits

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after first dose

Population: The analysis was performed on the total number of subjects who reported work loss after the first vaccination and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered

Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=5 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Days of Work Loss for Subjects After First Dose	1.3 Days Standard Deviation 1.0

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after second dose

Population: The analysis was performed on the total number of subjects who reported work loss after the second dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered

Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=13 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Days of Work Loss for Subjects After Second Dose	1.1 Days Standard Deviation 0.4

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after first dose

Population: The analysis was performed on the total number of non-dedicated caregivers who reported work loss after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered

Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after second dose

Population: The analysis was performed on the total number of non-dedicated caregivers who reported work loss after second dose and were a part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.

Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after first dose

Population: The analysis was performed on the total number of dedicated caregivers who reported extra work after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.

Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after second dose

Population: The analysis was performed on the total number of dedicated caregivers who reported extra work after second dose and were part of the exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.

Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

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

Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=400 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose Any Pain	310 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose Grade 3 Pain	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose Any Erythema	92 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose Grade 3 Erythema	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose Any Swelling	53 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose Grade 3 swelling	3 Participants

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

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

Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=389 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose Any Erythema	87 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose Grade 3 Erythema	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose Any Pain	292 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose Grade 3 Pain	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose Any Swelling	54 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose Grade 3 Swelling	3 Participants

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

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

Assessed solicited local symptoms were pain, erythema and swelling.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=400 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Days With Solicited Local Symptoms After First Dose Pain	3 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms After First Dose Erythema	2 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms After First Dose Swelling	2 Days Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

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

Assessed solicited local symptoms were pain, erythema and swelling.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=292 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Days With Solicited Local Symptoms After Second Dose Pain	2.5 Days Interval 2.0 to 3.0
Number of Days With Solicited Local Symptoms After Second Dose Erythema	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Local Symptoms After Second Dose Swelling	3.0 Days Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=400 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Any Fatigue	134 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Grade 3 Fatigue	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Related Fatigue	120 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Any Gastrointestinal symptoms	53 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Grade 3 Gastrointestinal symptoms	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Related Gastrointestinal symptoms	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Any Headache	113 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Grade 3 Headache	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Related Headache	98 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Any Myalgia	107 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Grade 3 Myalgia	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Related Myalgia	100 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Any Shivering	50 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Grade 3 Shivering	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Related Shivering	48 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Any Temperature (oral route)	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Grade 3 Temperature(≥39.0 °C)	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose Related Temperature	34 Participants

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature \[defined as oral, axillary, tympanic temperature ≥ 37.5 °C\]. 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 Group n=389 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Any Fatigue	180 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Grade 3 Fatigue	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Related Fatigue	172 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Any Gastrointestinal symptoms	53 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Grade 3 Gastrointestinal symptoms	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Related Gastrointestinal symptoms	44 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Any Headache	146 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Grade 3 Headache	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Related Headache	127 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Any Myalgia	128 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Grade 3 Myalgia	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Related Myalgia	121 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Any Shivering	97 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Grade 3 Shivering	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Related Shivering	86 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Any Temperature (oral route)	69 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Grade 3 Temperature(≥39.0 °C)	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose Related Temperature	64 Participants

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after first dose.

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=400 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Days With Solicited General Symptoms After First Dose Fatigue	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After First Dose Gastrointestinal symptoms	1 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After First Dose Headache	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After First Dose Myalgia	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After First Dose Shivering	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms After First Dose Temperature	1 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: During a 7-day follow-up period (Day 1 to Day 7) after second dose.

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=180 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Days With Solicited General Symptoms After Second Dose Fatigue	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After Second Dose Gastrointestinal symptoms	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After Second Dose Headache	1.5 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms After Second Dose Myalgia	2.0 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms After Second Dose Shivering	1.0 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms After Second Dose Temperature	1.0 Days Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses).

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

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

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=401 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any unsolicited adverse event	127 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 unsolicited adverse events	25 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related unsolicited adverse events	29 Participants

SECONDARY outcome

Timeframe: From Day 1 to study end at Month 14

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

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=401 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period Any SAEs	14 Participants
Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period Related SAEs	0 Participants

SECONDARY outcome

Timeframe: From Day 1 to study end at Month 14

Population: The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually 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

Outcome measures
Measure	GSK1437173A Group n=401 Participants Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) Any pIMDs	2 Participants
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) Related pIMDs	0 Participants

Adverse Events

GSK1437173A Group

Serious events: 14 serious events

Other events: 370 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	GSK1437173A Group n=401 participants at risk Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Cardiac disorders Aortic valve stenosis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Cardiac disorders Atrial fibrillation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Cardiac disorders Atrioventricular block complete	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Cardiac disorders Cardiomyopathy	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Cardiac disorders Coronary artery disease	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Cardiac disorders Stress cardiomyopathy	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Colitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Large intestine perforation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Diverticulitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Pneumonia	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Sepsis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Urinary tract infection	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Post procedural haematuria	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Post procedural inflammation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Vascular disorders Aortic stenosis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Death	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).

Other adverse events

Other adverse events
Measure	GSK1437173A Group n=401 participants at risk Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
Blood and lymphatic system disorders Lymphadenopathy	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Cardiac disorders Atrial fibrilation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Ear and labyrinth disorders Vertigo	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Eye disorders Conjunctivitis allergic	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Eye disorders Eye irritation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Eye disorders Eye pain	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Eye disorders Keratitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Constipation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Diarrhoea	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Gastrointestinal disorder	21.9% 88/401 • Number of events 107 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Haematochezia	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Haemorrhoids	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Nausea	1.00% 4/401 • Number of events 4 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Toothache	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Gastrointestinal disorders Vomiting	0.75% 3/401 • Number of events 3 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Application site erythema	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Application site hyperaesthesia	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Chills	28.7% 115/401 • Number of events 148 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Fatigue	56.6% 227/401 • Number of events 315 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Feeling cold	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Ill-defined disorder	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Inflammation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Injection site bruising	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders injection site erythema	31.2% 125/401 • Number of events 180 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Injection site pain	85.0% 341/401 • Number of events 603 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Injection site pruritus	2.0% 8/401 • Number of events 9 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Injection site warmth	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Malaise	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Oedema peripheral	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Pain	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Peripheral swelling	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Pyrexia	21.9% 88/401 • Number of events 107 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Immune system disorders Seasonal allergy	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Bronchitis	1.2% 5/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Cystitis	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Eye infection staphilococcal	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Fungal infection	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Gastroenteritis viral	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Gastrointestinal viral infection	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Groin abcess	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Nasopharyngithis	2.5% 10/401 • Number of events 10 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Oral herpes	1.00% 4/401 • Number of events 4 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Pneumonia	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Rhinitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Sinusitis	1.5% 6/401 • Number of events 6 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Tooth abcess	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Tooth infection	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Upper respiratory tract infection	2.0% 8/401 • Number of events 8 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Urinary tract infection	1.00% 4/401 • Number of events 4 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Infections and infestations Viral infection	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Arthropod bite	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Arthropod sting	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Fall	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Foot fracture	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Injection related reaction	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Ligament sprain	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Meniscus injury	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Procedural dizziness	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Procedural pain	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Skin laceration	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Superficial injury of eye	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Injury, poisoning and procedural complications Tooth fracture	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Metabolism and nutrition disorders Decreased appetite	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Metabolism and nutrition disorders Gout	0.25% 1/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Arthralgia	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Back pain	1.2% 5/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Bursitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Joint effusion	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 5/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Muscle tightness	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.75% 3/401 • Number of events 4 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Myalgia	42.1% 169/401 • Number of events 238 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Neck pain	1.00% 4/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Osteoporosis	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Pain in extremity	1.2% 5/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Musculoskeletal and connective tissue disorders Tendonitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Dizziness	1.2% 5/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Headache	47.1% 189/401 • Number of events 268 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Hypoaesthesia	0.75% 3/401 • Number of events 4 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Lethargy	0.75% 3/401 • Number of events 3 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Migraine	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Paraesthesia	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Sciatica	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Nervous system disorders Sinus headache	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Psychiatric disorders Anxiety	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Psychiatric disorders Insomnia	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Psychiatric disorders Panic attack	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Psychiatric disorders Stress	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Renal and urinary disorders Nephrolithiasis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Renal and urinary disorders Urinary tract disorder	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Renal and urinary disorders Urine odour abnormal	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Reproductive system and breast disorders Pelvic pain	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Cough	2.5% 10/401 • Number of events 10 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.2% 5/401 • Number of events 5 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.00% 4/401 • Number of events 4 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Skin and subcutaneous tissue disorders Dermatitis	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Skin and subcutaneous tissue disorders Erythema	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Skin and subcutaneous tissue disorders Night sweats	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Skin and subcutaneous tissue disorders Rash	0.50% 2/401 • Number of events 2 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Surgical and medical procedures Sinus operation	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
Vascular disorders Flushing	0.25% 1/401 • Number of events 1 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).
General disorders Injection site swelling	19.5% 78/401 • Number of events 107 • Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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