Trial Outcomes & Findings for A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine (NCT NCT03443427)

NCT ID: NCT03443427

Last Updated: 2021-08-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361
• Results posted on: 2021-08-31

Participant Flow

Participant milestones

Measure	Schedule 0-2-6 Group Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Overall Study STARTED	100	100
Overall Study COMPLETED	88	89
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Measure	Schedule 0-2-6 Group Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Overall Study Adverse Event	2	3
Overall Study CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT	6	2
Overall Study Other	4	6

Baseline Characteristics

A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine

Baseline characteristics by cohort

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).	Total n=200 Participants Total of all reporting groups
Age, Continuous	58.4 Years STANDARD_DEVIATION 10.3 • n=5 Participants	59.8 Years STANDARD_DEVIATION 10.1 • n=7 Participants	59.1 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	43 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	57 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	100 Participants n=5 Participants	99 Participants n=7 Participants	199 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361

Population: Analysis was performed on the Exposed Set (ES) which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided solicited safety data.

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

Outcome measures

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Any, Dose 1	64 Participants	64 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Grade 3, Dose 1	2 Participants	1 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Any, Dose 2	72 Participants	69 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Grade 3, Dose 2	13 Participants	3 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Any, Dose 3	67 Participants	4 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Grade 3, Dose 3	12 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Any, Dose 4	9 Participants	73 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Pain, Grade 3, Dose 4	0 Participants	8 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Any, Dose 1	9 Participants	18 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Grade 3, Dose 1	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Any, Dose 2	12 Participants	11 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Grade 3, Dose 2	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Any, Dose 3	13 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Grade 3, Dose 3	1 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Any, Dose 4	1 Participants	12 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Redness, Grade 3, Dose 4	0 Participants	1 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Any, Dose 1	8 Participants	10 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Grade 3, Dose 1	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Any, Dose 2	7 Participants	7 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Grade 3, Dose 2	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Any, Dose 3	9 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Grade 3, Dose 3	1 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Any, Dose 4	1 Participants	10 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Swelling, Grade 3, Dose 4	0 Participants	1 Participants

PRIMARY outcome

Timeframe: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361

Population: Analysis was performed on the Exposed Set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided solicited safety data.

Assessed solicited general symptoms were chills, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), fatigue, myalgia, headache and fever [defined Oral cavity or axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C.

Outcome measures

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Any, Dose 1	6 Participants	5 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Grade 3, Dose 1	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Any, Dose 2	13 Participants	8 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Grade 3, Dose 2	4 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Any, Dose 3	12 Participants	2 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Grade 3, Dose 3	4 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Any, Dose 4	2 Participants	18 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Chills, Grade 3, Dose 4	1 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Any, Dose 1	11 Participants	7 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Grade 3, Dose 1	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Any, Dose 2	11 Participants	10 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Grade 3, Dose 2	1 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Any, Dose 3	9 Participants	7 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Grade 3, Dose 3	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Any, Dose 4	3 Participants	15 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Gastrointestinal symptoms, Grade 3, Dose 4	1 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Any, Dose 1	22 Participants	16 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Grade 3, Dose 1	0 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Any, Dose 2	28 Participants	32 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Grade 3, Dose 2	9 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Any, Dose 3	20 Participants	13 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Grade 3, Dose 3	4 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Any, Dose 4	8 Participants	35 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Grade 3, Dose 2	7 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Any, Dose 1	13 Participants	15 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Any, Dose 3	20 Participants	3 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Grade 3, Dose 3	6 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Any, Dose 4	4 Participants	28 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fatigue, Grade 3, Dose 4	3 Participants	5 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Any, Dose 1	17 Participants	16 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Grade 3, Dose 1	1 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Any, Dose 2	22 Participants	23 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Grade 3, Dose 1	0 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Any, Dose 2	24 Participants	21 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Grade 3, Dose 2	2 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Any, Dose 3	24 Participants	7 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Grade 3, Dose 3	4 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Any, Dose 3	4 Participants	2 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Grade 3, Dose 3	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Any, Dose 4	3 Participants	5 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Grade 3, Dose 4	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Myalgia, Grade 3, Dose 4	1 Participants	5 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Any, Dose 4	5 Participants	27 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Headache, Grade 3, Dose 4	1 Participants	1 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Any, Dose 1	3 Participants	3 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Grade 3, Dose 1	0 Participants	0 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Any, Dose 2	3 Participants	6 Participants
Number of Subjects Reported With Each Solicited General Adverse Event (AE) (Any and Grade 3) Within Each Vaccination Schedule Fever, Grade 3, Dose 2	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered at Day 1, Day 61, Day 181 and Day 361

Population: Analysis was performed on the Exposed Set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided unsolicited safety data.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Outcome measures

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Any Unsolicited Adverse Event (AE) Within Each Vaccination Schedule Dose 1	16 Participants	20 Participants
Number of Subjects Reported With Any Unsolicited Adverse Event (AE) Within Each Vaccination Schedule Dose 2	15 Participants	20 Participants
Number of Subjects Reported With Any Unsolicited Adverse Event (AE) Within Each Vaccination Schedule Dose 3	13 Participants	11 Participants
Number of Subjects Reported With Any Unsolicited Adverse Event (AE) Within Each Vaccination Schedule Dose 4	7 Participants	9 Participants

PRIMARY outcome

Timeframe: From first vaccination (Day 1) up to Day 541 (an average of 18 months)

Population: Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided safety data.

An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.

Outcome measures

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Any Serious Adverse Event (SAE) Within Each Vaccination Schedule	12 Participants	8 Participants

PRIMARY outcome

Timeframe: From first vaccination (Day 1) up to Day 541 (an average of 18 months)

Population: Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided safety data.

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

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs) Within Each Vaccination Schedule	3 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 541 up to Day 721 (an average of 6 months)

Population: Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose administered and who provided safety data.

An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.

Outcome measures

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Any SAE Within Each Vaccination Schedule	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From Day 541 up to Day 721 (an average of 6 months)

Population: Analysis was performed on the Exposed set which included all eligible subjects, enrolled in this study, who provided informed consent, had at least one vaccine dose.

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

Outcome measures

Measure	Schedule 0-2-6 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Subjects Reported With Any pIMDs Within Each Vaccination Schedule	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

Anti-Protein D (PD) antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (153 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 1	88 EU/mL Interval 79.2 to 97.9	88.1 EU/mL Interval 79.8 to 97.2
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 91	1365.5 EU/mL Interval 1073.0 to 1737.8	1394.1 EU/mL Interval 1116.9 to 1740.1
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 181	853.4 EU/mL Interval 665.4 to 1094.6	835.6 EU/mL Interval 665.4 to 1049.3
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 211	2338 EU/mL Interval 1840.1 to 2970.8	679 EU/mL Interval 541.7 to 850.9
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 361	1199 EU/mL Interval 942.8 to 1524.9	483.1 EU/mL Interval 386.4 to 603.9
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 391	1064.1 EU/mL Interval 829.4 to 1365.2	2677 EU/mL Interval 2111.4 to 3394.1
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 541	826.5 EU/mL Interval 646.3 to 1057.0	1346.4 EU/mL Interval 1072.1 to 1690.8
Anti-Protein D (PD) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 721	679.6 EU/mL Interval 529.5 to 872.1	900.4 EU/mL Interval 716.1 to 1132.2

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

Anti-Protein E (PE) antibody concentrations as determined by ELISA, and expressed in EU/mL. Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (16 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 1	19.6 EU/mL Interval 15.1 to 25.5	18.4 EU/mL Interval 14.5 to 23.5
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 91	5867.9 EU/mL Interval 4644.4 to 7413.8	5896.7 EU/mL Interval 4755.2 to 7312.3
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 181	2649.1 EU/mL Interval 2113.3 to 3320.7	2787.1 EU/mL Interval 2266.0 to 3428.0
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 211	7557.1 EU/mL Interval 6107.9 to 9350.0	2309.9 EU/mL Interval 1892.1 to 2819.8
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 361	2735.3 EU/mL Interval 2196.7 to 3406.1	1298 EU/mL Interval 1058.6 to 1591.6
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 391	2604.2 EU/mL Interval 2118.3 to 3201.5	9339.4 EU/mL Interval 7670.2 to 11372.0
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 541	1762.2 EU/mL Interval 1443.9 to 2150.6	3620.7 EU/mL Interval 3009.9 to 4355.4
Anti-Protein E (PE) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 721	1348.3 EU/mL Interval 1085.6 to 1674.7	1942.0 EU/mL Interval 1591.0 to 2370.5

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

Anti-type IV pili subunit (PilA) antibody concentrations as determined by ELISA, and expressed in EU/mL. Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (8 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 1	10.9 EU/mL Interval 8.5 to 14.2	8.3 EU/mL Interval 6.5 to 10.5
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 91	992.5 EU/mL Interval 747.2 to 1318.5	893.1 EU/mL Interval 688.6 to 1158.3
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 181	589.3 EU/mL Interval 442.8 to 784.3	504.2 EU/mL Interval 388.4 to 654.3
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 211	1191.7 EU/mL Interval 920.0 to 1543.6	396.3 EU/mL Interval 310.9 to 505.2
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 361	546.6 EU/mL Interval 418.1 to 714.5	250.3 EU/mL Interval 195.3 to 320.7
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 391	456.4 EU/mL Interval 360.7 to 577.6	1163.9 EU/mL Interval 931.1 to 1454.9
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 541	330.4 EU/mL Interval 260.5 to 419.1	524.3 EU/mL Interval 421.0 to 653.1
Anti-Type IV Pili Subunit (PilA) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 721	242.9 EU/mL Interval 186.4 to 316.5	305.5 EU/mL Interval 239.8 to 389.2

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations as determined by ELISA, and expressed in EU/mL. Calculation of the GMCs are performed by taking the anti-logarithm in base 10 (anti-log10) of the mean of the log10 concentration transformations. Antibody concentrations below the assay cut-off (28 EU/mL) is given an arbitrary value of half the assay cut-off for the purpose of GMC calculation.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 1	682.4 EU/mL Interval 544.4 to 855.4	544.9 EU/mL Interval 441.8 to 672.1
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 91	1364.5 EU/mL Interval 1217.6 to 1529.1	1159.7 EU/mL Interval 1044.8 to 1287.2
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 181	1019.7 EU/mL Interval 920.9 to 1129.0	915.2 EU/mL Interval 834.1 to 1004.3
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 211	1270.9 EU/mL Interval 1138.1 to 1419.2	864.6 EU/mL Interval 779.5 to 959.1
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 361	885.8 EU/mL Interval 801.7 to 978.8	730 EU/mL Interval 665.6 to 800.6
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 391	909.9 EU/mL Interval 818.5 to 1011.4	1142.8 EU/mL Interval 1033.9 to 1263.3
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 541	898.2 EU/mL Interval 811.5 to 994.2	847.4 EU/mL Interval 771.6 to 930.7
Anti-Ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, as Measured by ELISA, Within Each Vaccination Schedule Day 721	790.6 EU/mL Interval 705.1 to 886.6	715.2 EU/mL Interval 644.0 to 794.1

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 153 EU/mL).Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 1	7 Participants	12 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 91	78 Participants	80 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 181	75 Participants	80 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 211	81 Participants	75 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 361	78 Participants	71 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 391	77 Participants	81 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 541	76 Participants	79 Participants
Number of Seropositive Subjects for Anti-PD Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 721	72 Participants	74 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 16 EU/mL). Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 1	43 Participants	43 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 91	79 Participants	82 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 181	81 Participants	87 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 211	80 Participants	84 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 361	82 Participants	87 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 391	81 Participants	82 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 541	80 Participants	84 Participants
Number of Seropositive Subjects for Anti-PE Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 721	77 Participants	79 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 8 EU/mL).Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 1	40 Participants	36 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 91	79 Participants	82 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 181	81 Participants	87 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 211	81 Participants	83 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 361	82 Participants	84 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 391	81 Participants	82 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 541	80 Participants	84 Participants
Number of Seropositive Subjects for Anti- PilA Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 721	75 Participants	79 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721

Population: Analysis was performed on the Per Protocol Set which included all eligible subjects, enrolled in this study, who provided informed consent, who complied with the vaccination schedule and who provided immunogenicity data according to blood sample timings specified in the protocol

A Seropositive subject is defined as a subject whose antibody concentration is greater than or equal to the assay cut off (i.e. the ELISA lower limit of quantification = 28 EU/mL).Antibody concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), and expressed in EU/mL.

Outcome measures

Measure	Schedule 0-2-6 Group n=82 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=87 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 1	82 Participants	87 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 91	79 Participants	82 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 181	81 Participants	87 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 211	81 Participants	84 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 361	82 Participants	87 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 391	81 Participants	82 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 541	80 Participants	84 Participants
Number of Seropositive Subjects for Anti- UspA2 Antibody, as Measured by ELISA, Within Each Vaccination Schedule Day 721	77 Participants	79 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 181, Day 211, Day 361 and Day 391

Population: Analysis was performed on a subset of subjects (CMI sub cohort), which included approximately 20 subjects in each group,for which additional blood sample was taken at each pre-defined timepoint.

Frequency of specific CD4+ T-cells were measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers [such as Interleukin-2 (IL-2), IL-13, IL-17, Interferon-γ (IFN-γ), Tumor Necrosis Factor-α (TNF-α) and Cluster of Differentiation 40 Ligand (CD40L)]. The frequency of specific CD4+ T-cells are summarized with following descriptive statistics: Mean and standard deviation (SD) against each antigen (PD, PE,PilA and UspA2), by group and at each time point for which blood samples were collected for Cell-Mediated Immunity (CMI). The CMI sub-cohort subjects were selected from sites able to process the blood samples according to GSK procedures for peripheral blood mononuclear cell (PBMC) preparation.

Outcome measures

Measure	Schedule 0-2-6 Group n=21 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=19 Participants Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PD, Day 1	76.995 CD4+ T-cells/million cells Standard Deviation 142.760	55.173 CD4+ T-cells/million cells Standard Deviation 109.539
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PD, Day 91	865.933 CD4+ T-cells/million cells Standard Deviation 919.585	1076.136 CD4+ T-cells/million cells Standard Deviation 970.670
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PD, Day 181	381.265 CD4+ T-cells/million cells Standard Deviation 356.496	463.939 CD4+ T-cells/million cells Standard Deviation 558.441
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PD, Day 211	664.044 CD4+ T-cells/million cells Standard Deviation 610.930	518.104 CD4+ T-cells/million cells Standard Deviation 513.462
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PD, Day 361	444.129 CD4+ T-cells/million cells Standard Deviation 520.204	378.78 CD4+ T-cells/million cells Standard Deviation 456.970
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PD, Day 391	321.28 CD4+ T-cells/million cells Standard Deviation 316.073	761.605 CD4+ T-cells/million cells Standard Deviation 974.791
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PE, Day 1	28.869 CD4+ T-cells/million cells Standard Deviation 44.944	21.223 CD4+ T-cells/million cells Standard Deviation 38.682
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PE, Day 91	1406.663 CD4+ T-cells/million cells Standard Deviation 1900.558	926.809 CD4+ T-cells/million cells Standard Deviation 785.046
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PE, Day 181	551.444 CD4+ T-cells/million cells Standard Deviation 635.058	352.471 CD4+ T-cells/million cells Standard Deviation 403.081
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PE, Day 211	986.138 CD4+ T-cells/million cells Standard Deviation 1570.491	463.076 CD4+ T-cells/million cells Standard Deviation 395.158
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PE, Day 361	636.539 CD4+ T-cells/million cells Standard Deviation 995.486	305.772 CD4+ T-cells/million cells Standard Deviation 337.400
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PE, Day 391	590.426 CD4+ T-cells/million cells Standard Deviation 714.051	481.133 CD4+ T-cells/million cells Standard Deviation 533.658
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PilA, Day 1	81.03 CD4+ T-cells/million cells Standard Deviation 178.861	79.205 CD4+ T-cells/million cells Standard Deviation 210.642
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PilA, Day 91	615.698 CD4+ T-cells/million cells Standard Deviation 686.114	523.195 CD4+ T-cells/million cells Standard Deviation 493.956
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PilA, Day 181	356.275 CD4+ T-cells/million cells Standard Deviation 350.909	265.097 CD4+ T-cells/million cells Standard Deviation 267.351
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PilA, Day 211	524.754 CD4+ T-cells/million cells Standard Deviation 654.443	257.806 CD4+ T-cells/million cells Standard Deviation 252.382
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PilA, Day 361	341.58 CD4+ T-cells/million cells Standard Deviation 433.970	205.388 CD4+ T-cells/million cells Standard Deviation 220.979
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens NTHi.PilA, Day 391	334.088 CD4+ T-cells/million cells Standard Deviation 300.114	368.693 CD4+ T-cells/million cells Standard Deviation 354.449
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens M catarrhalis.UspA2, Day 1	85.785 CD4+ T-cells/million cells Standard Deviation 99.051	53.391 CD4+ T-cells/million cells Standard Deviation 80.742
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens M catarrhalis.UspA2, Day 91	964.521 CD4+ T-cells/million cells Standard Deviation 709.134	730.725 CD4+ T-cells/million cells Standard Deviation 575.778
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens M catarrhalis.UspA2, Day 181	559.062 CD4+ T-cells/million cells Standard Deviation 524.096	355.992 CD4+ T-cells/million cells Standard Deviation 346.277
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens M catarrhalis.UspA2, Day 211	846.177 CD4+ T-cells/million cells Standard Deviation 750.349	424.981 CD4+ T-cells/million cells Standard Deviation 329.334
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens M catarrhalis.UspA2, Day 361	635.022 CD4+ T-cells/million cells Standard Deviation 617.485	347.65 CD4+ T-cells/million cells Standard Deviation 363.499
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Producing 2 or More Markers Upon in Vitro Stimulation With the Antigen, by NTHi and Mcat Antigens M catarrhalis.UspA2, Day 391	545.436 CD4+ T-cells/million cells Standard Deviation 464.272	474.238 CD4+ T-cells/million cells Standard Deviation 446.236

Adverse Events

Schedule 0-2-6 Group

Serious events: 12 serious events

Other events: 93 other events

Deaths: 1 deaths

Schedule 0-2-12 Group

Serious events: 9 serious events

Other events: 97 other events

Deaths: 2 deaths

Serious adverse events

Measure	Schedule 0-2-6 Group n=100 participants at risk Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 participants at risk Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Cardiac disorders Acute myocardial infarction	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Cardiac disorders Atrial flutter	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Cardiac disorders Myocardial infarction	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Cardiac disorders Right ventricular failure	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Colitis ulcerative	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Death	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Non-cardiac chest pain	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Cellulitis	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Diverticulitis	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Pneumonia	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Urinary tract infection	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Chest injury	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Head injury	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Tooth injury	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Cerebral artery occlusion	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Syncope	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Transient ischaemic attack	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Psychiatric disorders Conversion disorder	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Renal and urinary disorders Acute kidney injury	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Vascular disorders Aortic aneurysm	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Hemiparesis	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721

Other adverse events

Measure	Schedule 0-2-6 Group n=100 participants at risk Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 181 (Month 6) and one dose of placebo at Day 361 (Month 12).	Schedule 0-2-12 Group n=100 participants at risk Subjects between, and including, 40 and 80 years of age at the time of the first vaccination, receiving three doses of the GSK3277511A investigational vaccine at Day 1 (Month 0), Day 61 (Month 2) and Day 361 (Month 12) and one dose of placebo at Day 181 (Month 6).
Blood and lymphatic system disorders Iron deficiency anaemia	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Ear and labyrinth disorders Ear discomfort	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Ear and labyrinth disorders Ear pain	1.0% 1/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Ear and labyrinth disorders Vertigo	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Eye disorders Cataract	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Eye disorders Dry eye	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Eye disorders Vision blurred	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Abdominal discomfort	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Abdominal pain	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Abdominal pain upper	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Diarrhoea	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	3.0% 3/100 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Dry mouth	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Dyspepsia	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Food poisoning	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Gastrointestinal disorder	25.0% 25/100 • Number of events 34 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	28.0% 28/100 • Number of events 40 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Haemorrhoids	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Large intestine polyp	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Nausea	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Toothache	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Administration site pruritus	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Chest pain	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Chills	24.0% 24/100 • Number of events 33 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	25.0% 25/100 • Number of events 34 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Fatigue	44.0% 44/100 • Number of events 79 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	50.0% 50/100 • Number of events 97 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Feeling hot	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Influenza like illness	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Injection site erythema	21.0% 21/100 • Number of events 35 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	28.0% 28/100 • Number of events 41 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Injection site pain	89.0% 89/100 • Number of events 213 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	92.0% 92/100 • Number of events 210 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Injection site pruritus	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Injection site swelling	16.0% 16/100 • Number of events 25 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	20.0% 20/100 • Number of events 27 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Non-cardiac chest pain	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Peripheral swelling	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Pyrexia	11.0% 11/100 • Number of events 13 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	13.0% 13/100 • Number of events 16 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Immune system disorders Seasonal allergy	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Alveolar osteitis	1.0% 1/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Eye infection	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Gingival abscess	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Infected bite	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Localised infection	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Nasopharyngitis	6.0% 6/100 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	6.0% 6/100 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Ophthalmic herpes simplex	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Pneumonia	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Respiratory tract infection	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Sinusitis	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Tooth infection	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Upper respiratory tract infection	3.0% 3/100 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Urinary tract infection	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Vaginal infection	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Infections and infestations Viral upper respiratory tract infection	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Concussion	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Contusion	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Injury, poisoning and procedural complications Muscle strain	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Investigations Gamma-glutamyltransferase increased	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Investigations Weight increased	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Metabolism and nutrition disorders Decreased appetite	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Metabolism and nutrition disorders Gout	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Back pain	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	4.0% 4/100 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Limb discomfort	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Muscle spasms	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Myalgia	38.0% 38/100 • Number of events 63 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	41.0% 41/100 • Number of events 73 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Dizziness	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Headache	39.0% 39/100 • Number of events 69 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	41.0% 41/100 • Number of events 71 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Hypoaesthesia	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Migraine	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Nerve compression	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Presyncope	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Sciatica	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Nervous system disorders Tremor	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Psychiatric disorders Anxiety	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Psychiatric disorders Hallucination	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Psychiatric disorders Insomnia	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Psychiatric disorders Stress	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Reproductive system and breast disorders Testicular pain	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Cough	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	3.0% 3/100 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.0% 1/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Respiratory, thoracic and mediastinal disorders Wheezing	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Erythema	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Pruritus	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Psoriasis	1.0% 1/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Skin and subcutaneous tissue disorders Rash	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Vascular disorders Hot flush	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Vascular disorders Hypertension	0.00% 0/100 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	4.0% 4/100 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
General disorders Illness	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721
Musculoskeletal and connective tissue disorders Arthralgia	1.0% 1/100 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721	2.0% 2/100 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up (FU) period after any vaccination. Unsolicited AEs during the 30-day follow-up (FU) period after any vaccination and SAEs from Day 1 to Day 721

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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