Trial Outcomes & Findings for A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response. (NCT NCT03281876)

Last Updated: 2021-01-11

Results Overview

Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

606 participants

Primary outcome timeframe

From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Results posted on

2021-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	GSK3277511A Group Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Overall Study STARTED	304	302
Overall Study COMPLETED	281	263
Overall Study NOT COMPLETED	23	39

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK3277511A Group Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Overall Study Adverse Event	4	15
Overall Study Lost to Follow-up	1	4
Overall Study Withdrawal by Subject	11	15
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	2	0
Overall Study OTHER	5	5

Baseline Characteristics

A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3277511A Group n=304 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=302 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.	Total n=606 Participants Total of all reporting groups
Age, Continuous	65.7 Years STANDARD_DEVIATION 7.5 • n=5 Participants	66.3 Years STANDARD_DEVIATION 7.3 • n=7 Participants	66.0 Years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	125 Participants n=7 Participants	245 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants	177 Participants n=7 Participants	361 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 Asian - Central / South Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	294 Participants n=5 Participants	296 Participants n=7 Participants	590 Participants n=5 Participants

PRIMARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Population: The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year	1.22 exacerbations per person-year Interval 1.09 to 1.36	1.17 exacerbations per person-year Interval 1.06 to 1.3

PRIMARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year	1.22 exacerbations per person-year Interval 1.05 to 1.41	1.17 exacerbations per person-year Interval 1.02 to 1.34

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided solicited safey data.

Assessed solicited local symptoms were pain, redness and swelling

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=291 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) Pain, Dose 1	153 Participants	16 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) Pain, Dose 2	163 Participants	13 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) Redness (mm), Dose 1	18 Participants	1 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) Redness (mm), Dose 2	37 Participants	0 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) Swelling (mm), Dose 1	13 Participants	2 Participants
Number of Subjects Reported With Each Solicited Local Adverse Event (AE) Swelling (mm), Dose 2	31 Participants	0 Participants

SECONDARY outcome

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

Assessed solicited general symptoms were Chills, fatigue, fever \[defined as (oral cavity or axillary) temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache and myalgia.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=291 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects Reported With Each Solicited General AE Myalgia, Dose 1	78 Participants	72 Participants
Number of Subjects Reported With Each Solicited General AE Headache, Dose 2	75 Participants	64 Participants
Number of Subjects Reported With Each Solicited General AE Myalgia, Dose 2	74 Participants	43 Participants
Number of Subjects Reported With Each Solicited General AE Chills, Dose 1	29 Participants	35 Participants
Number of Subjects Reported With Each Solicited General AE Chills, Dose 2	35 Participants	28 Participants
Number of Subjects Reported With Each Solicited General AE Fatigue, Dose 1	157 Participants	167 Participants
Number of Subjects Reported With Each Solicited General AE Fatigue, Dose 2	136 Participants	130 Participants
Number of Subjects Reported With Each Solicited General AE Fever, Dose 1	24 Participants	25 Participants
Number of Subjects Reported With Each Solicited General AE Fever, Dose 2	18 Participants	11 Participants
Number of Subjects Reported With Each Solicited General AE Gastrointestinal symptoms, Dose 1	47 Participants	54 Participants
Number of Subjects Reported With Each Solicited General AE Gastrointestinal symptoms, Dose 2	39 Participants	35 Participants
Number of Subjects Reported With Each Solicited General AE Headache, Dose 1	98 Participants	76 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=304 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=302 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects Reported With Any Unsolicited Adverse Event (AE)	110 Participants	103 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to Study end (at Day 451)

Population: The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided safety data.

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

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=304 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=302 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to Study end (at Day 451)

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one documented study vaccine administration and who provided safety data.

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

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=304 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=302 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects Reported With Any Serious Adverse Event (SAE)	89 Participants	99 Participants

SECONDARY outcome

Timeframe: During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)

The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The severity of AECOPD can be graded according to the intensity of medical intervention required. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 0 TO 3 MONTHS	1.35 exacerbations per person-year Interval 1.1 to 1.66	1.15 exacerbations per person-year Interval 0.92 to 1.43
Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 3 TO 6 MONTHS	1.33 exacerbations per person-year Interval 1.08 to 1.63	1.44 exacerbations per person-year Interval 1.19 to 1.75
Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 6 TO 9 MONTHS	1.36 exacerbations per person-year Interval 1.11 to 1.67	1.19 exacerbations per person-year Interval 0.96 to 1.48
Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 9 TO 12 MONTHS	0.87 exacerbations per person-year Interval 0.69 to 1.11	0.9 exacerbations per person-year Interval 0.71 to 1.14

SECONDARY outcome

Timeframe: During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months, 0-12 months (observation starting 1 month post-Dose 2)

The rates of any AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The intention of the analysis of the Rate during 3, 6, 9 and 12 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 and 0-12 months.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 0 TO 3 MONTHS	1.47 exacerbations per person-year Interval 1.21 to 1.79	1.33 exacerbations per person-year Interval 1.09 to 1.63
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 3 TO 6 MONTHS	1.56 exacerbations per person-year Interval 1.29 to 1.89	1.56 exacerbations per person-year Interval 1.29 to 1.88
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 6 TO 9 MONTHS	1.49 exacerbations per person-year Interval 1.23 to 1.82	1.29 exacerbations per person-year Interval 1.05 to 1.59
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period FROM 9 TO 12 MONTHS	0.98 exacerbations per person-year Interval 0.78 to 1.22	1.04 exacerbations per person-year Interval 0.84 to 1.3
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period From 0 TO 12 MONTHS	1.36 exacerbations per person-year Interval 1.19 to 1.57	1.31 exacerbations per person-year Interval 1.15 to 1.48

SECONDARY outcome

Timeframe: During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)

The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: It is calculated proportionally to the follow-up time per subject and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for each period considered. The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MILD, FROM 0 TO 3 MONTHS	0.02 exacerbations per person Standard Deviation 0.15	0.03 exacerbations per person Standard Deviation 0.20
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MILD, FROM 3 TO 6 MONTHS	0.05 exacerbations per person Standard Deviation 0.24	0.02 exacerbations per person Standard Deviation 0.14
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MILD, FROM 6 TO 9 MONTHS	0.03 exacerbations per person Standard Deviation 0.19	0.03 exacerbations per person Standard Deviation 0.18
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MILD, FROM 9 TO 12 MONTHS	0.03 exacerbations per person Standard Deviation 0.17	0.03 exacerbations per person Standard Deviation 0.16
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MODERATE, FROM 0 TO 3 MONTHS	0.29 exacerbations per person Standard Deviation 0.62	0.23 exacerbations per person Standard Deviation 0.48
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MODERATE, FROM 3 TO 6 MONTHS	0.27 exacerbations per person Standard Deviation 0.51	0.3 exacerbations per person Standard Deviation 0.57
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MODERATE, FROM 6 TO 9 MONTHS	0.3 exacerbations per person Standard Deviation 0.56	0.25 exacerbations per person Standard Deviation 0.51
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period MODERATE, FROM 9 TO 12 MONTHS	0.2 exacerbations per person Standard Deviation 0.44	0.17 exacerbations per person Standard Deviation 0.42
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period SEVERE, FROM 0 TO 3 MONTHS	0.04 exacerbations per person Standard Deviation 0.24	0.05 exacerbations per person Standard Deviation 0.23
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period SEVERE, FROM 3 TO 6 MONTHS	0.05 exacerbations per person Standard Deviation 0.22	0.06 exacerbations per person Standard Deviation 0.29
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period SEVERE, FROM 6 TO 9 MONTHS	0.05 exacerbations per person Standard Deviation 0.29	0.05 exacerbations per person Standard Deviation 0.24
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period SEVERE, FROM 9 TO 12 MONTHS	0.01 exacerbations per person Standard Deviation 0.11	0.05 exacerbations per person Standard Deviation 0.24

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Number of subjects with first occurrence of moderate or severe episode of AECOPD was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects With First Moderate or Severe AECOPD	158 Participants	176 Participants

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Number of subjects with first occurrence of any episode of AECOPD of any severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects With First AECOPD of Any Severity	168 Participants	188 Participants

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Number of subjects with first occurrence of any episode of AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects With First AECOPD Classified by Severity AFTER 1 MONTH POST DOSE 2, MILD	27 Participants	27 Participants
Number of Subjects With First AECOPD Classified by Severity AFTER 1 MONTH POST DOSE 2, MODERATE	144 Participants	154 Participants
Number of Subjects With First AECOPD Classified by Severity AFTER 1 MONTH POST DOSE 2, SEVERE	30 Participants	41 Participants

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=279 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Days With Moderate and Severe AECOPDs	16.6 Days Standard Deviation 14.29	15.6 Days Standard Deviation 13.93

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=279 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Days With AECOPDs of Any Severity	15.9 Days Standard Deviation 13.79	15.3 Days Standard Deviation 13.51

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=279 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Days With AECOPDs Classified by Severity MILD, AFTER 1 MONTH POST DOSE 2	8.9 Days Standard Deviation 3.56	12.3 Days Standard Deviation 9.11
Number of Days With AECOPDs Classified by Severity MODERATE, AFTER 1 MONTH POST DOSE 2	16.1 Days Standard Deviation 13.90	14.5 Days Standard Deviation 10.50
Number of Days With AECOPDs Classified by Severity SEVERE, AFTER 1 MONTH POST DOSE 2	20.4 Days Standard Deviation 16.78	21.2 Days Standard Deviation 23.85

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD	0.32 exacerbations per person-year Interval 0.25 to 0.42	0.32 exacerbations per person-year Interval 0.24 to 0.42

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The rates of AECOPD of any severity were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by polymerase chain reaction (PCR) analysis in sputum samples.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity	0.39 exacerbations per person- year Interval 0.3 to 0.5	0.35 exacerbations per person- year Interval 0.27 to 0.45

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: it is calculated proportionally to the follow-up time per subject, and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for the period considered. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity MILD, AFTER 1 MONTH POST DOSE 2	0.06 exacerbations per person Standard Deviation 0.28	0.03 exacerbations per person Standard Deviation 0.21
Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity MODERATE, AFTER 1 MONTH POST DOSE 2	0.3 exacerbations per person Standard Deviation 0.67	0.31 exacerbations per person Standard Deviation 0.74
Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity SEVERE, AFTER 1 MONTH POST DOSE 2	0.02 exacerbations per person Standard Deviation 0.18	0.01 exacerbations per person Standard Deviation 0.11

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Number of subjects with first occurrence of moderate or severe NTHI-associated and/or Mcat-associated AECOPD was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD	62 Participants	62 Participants

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD of any severity was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity	70 Participants	67 Participants

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=278 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity AFTER 1 MONTH POST DOSE 2, MILD	15 Participants	7 Participants
Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity AFTER 1 MONTH POST DOSE 2, MODERATE	58 Participants	59 Participants
Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity AFTER 1 MONTH POST DOSE 2, SEVERE	4 Participants	4 Participants

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=279 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD	14 Days Standard Deviation 10.43	12.3 Days Standard Deviation 5.59

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=279 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity	13.3 Days Standard Deviation 9.76	12.1 Days Standard Deviation 5.72

SECONDARY outcome

Timeframe: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)

The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=279 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=292 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity AFTER 1 MONTH POST DOSE 2, MILD	9.5 Days Standard Deviation 3.54	9.9 Days Standard Deviation 6.83
Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity AFTER 1 MONTH POST DOSE 2, MODERATE	13.8 Days Standard Deviation 10.41	12.5 Days Standard Deviation 5.62
Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity AFTER 1 MONTH POST DOSE 2, SEVERE	17.3 Days Standard Deviation 11.02	7.5 Days Standard Deviation 1.00

SECONDARY outcome

Timeframe: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451

Population: The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.

Anti-Protein D (PD) antibody concentrations as determined by ELISA, and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). For anti-PD antibodies, the cut-off of the assay is 153 ELISA Units per millilitre (EU/mL.)

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=247 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=256 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA) Day 1	103.7 EU/mL. Interval 93.8 to 114.7	95.4 EU/mL. Interval 86.3 to 105.4
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA) Day 31	1048.1 EU/mL. Interval 910.2 to 1206.8	98.2 EU/mL. Interval 85.3 to 113.1
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA) Day 61	654.6 EU/mL. Interval 572.3 to 748.9	95.5 EU/mL. Interval 83.6 to 109.1
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA) Day 91	1521.4 EU/mL. Interval 1357.6 to 1704.9	90.3 EU/mL. Interval 80.6 to 101.3
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA) Day 271	546 EU/mL. Interval 480.3 to 620.8	94.8 EU/mL. Interval 83.6 to 107.4
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA) Day 451	444.1 EU/mL. Interval 390.2 to 505.4	97.9 EU/mL. Interval 85.9 to 111.5

SECONDARY outcome

Timeframe: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451

Anti-Protein E (PE) antibody concentrations as determined by ELISA and expressed as GMCs in EU/mL For Anti-PE antibodies, the cut-off of the assay is 16 EU/mL.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=246 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=256 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Anti-PE Antibody Concentrations as Measured by ELISA Day 1	20.9 EU/mL. Interval 17.6 to 24.8	21.6 EU/mL. Interval 18.2 to 25.7
Anti-PE Antibody Concentrations as Measured by ELISA Day 31	1108.1 EU/mL. Interval 921.5 to 1332.5	20.7 EU/mL. Interval 17.2 to 24.9
Anti-PE Antibody Concentrations as Measured by ELISA Day 61	872.8 EU/mL. Interval 726.6 to 1048.3	20.5 EU/mL. Interval 17.1 to 24.6
Anti-PE Antibody Concentrations as Measured by ELISA Day 91	6020 EU/mL. Interval 5181.2 to 6994.7	20.1 EU/mL. Interval 17.3 to 23.4
Anti-PE Antibody Concentrations as Measured by ELISA Day 271	1254.9 EU/mL. Interval 1069.5 to 1472.5	19.3 EU/mL. Interval 16.5 to 22.5
Anti-PE Antibody Concentrations as Measured by ELISA Day 451	835.2 EU/mL. Interval 715.0 to 975.6	19.7 EU/mL. Interval 16.8 to 23.0

SECONDARY outcome

Timeframe: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451

Anti-Type IV pilus assembly protein (PilA) antibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-PilA antibodies, the cut-off of the assay is 8 EU/mL.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=247 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=256 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Anti-PilA Antibody Concentrations as Measured by ELISA Day 1	8.3 EU/mL. Interval 6.9 to 9.8	8.5 EU/mL. Interval 7.1 to 10.1
Anti-PilA Antibody Concentrations as Measured by ELISA Day 31	153 EU/mL. Interval 124.2 to 188.6	9.2 EU/mL. Interval 7.5 to 11.4
Anti-PilA Antibody Concentrations as Measured by ELISA Day 61	134.2 EU/mL. Interval 109.7 to 164.2	8.8 EU/mL. Interval 7.2 to 10.8
Anti-PilA Antibody Concentrations as Measured by ELISA Day 91	913.5 EU/mL. Interval 770.5 to 1082.9	8.9 EU/mL. Interval 7.5 to 10.5
Anti-PilA Antibody Concentrations as Measured by ELISA Day 271	189.6 EU/mL. Interval 159.2 to 225.7	8 EU/mL. Interval 6.8 to 9.5
Anti-PilA Antibody Concentrations as Measured by ELISA Day 451	126.5 EU/mL. Interval 106.1 to 150.8	8.3 EU/mL. Interval 6.9 to 9.9

SECONDARY outcome

Timeframe: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451

Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) aantibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-UspA2 antibodies, the cut-off of the assay is 28 EU/mL.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=246 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=255 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Anti-UspA2 Antibody Concentrations as Measured by ELISA Day 271	645.1 EU/mL Interval 582.1 to 714.8	445.4 EU/mL Interval 402.7 to 492.6
Anti-UspA2 Antibody Concentrations as Measured by ELISA Day 1	540.3 EU/mL Interval 452.6 to 645.0	604.7 EU/mL Interval 507.2 to 721.0
Anti-UspA2 Antibody Concentrations as Measured by ELISA Day 31	1092.1 EU/mL Interval 997.5 to 1195.5	485.2 EU/mL Interval 442.9 to 531.6
Anti-UspA2 Antibody Concentrations as Measured by ELISA Day 61	848.7 EU/mL Interval 781.5 to 921.5	473.5 EU/mL Interval 436.2 to 513.9
Anti-UspA2 Antibody Concentrations as Measured by ELISA Day 91	1223.7 EU/mL Interval 1110.8 to 1348.0	446 EU/mL Interval 404.5 to 491.8
Anti-UspA2 Antibody Concentrations as Measured by ELISA Day 451	575.9 EU/mL Interval 512.9 to 646.7	468.5 EU/mL Interval 416.5 to 527.1

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 271 and at Day 451

Population: The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.

The ICS staining assay was used to assess cell-mediated immunogenicity (CMI) responses. After Peripheral blood mononuclear cell (PBMC) stimulation with the relevant antigen, the frequency of PD specific CD4+ T-cells expressing selected combination of cytokines such as interleukine-2, 13, 17 (IL-2, IL-13, IL-17), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L) are evaluated by flow cytometry and expressed as mean and standard deviation.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=47 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=41 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 1	56.6 T cells/million cells Standard Deviation 125.7	59.7 T cells/million cells Standard Deviation 118.2
Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 91	890.2 T cells/million cells Standard Deviation 988.8	55.8 T cells/million cells Standard Deviation 88.2
Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 271	364.6 T cells/million cells Standard Deviation 363.9	51.8 T cells/million cells Standard Deviation 90.9
Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 451	267 T cells/million cells Standard Deviation 282.6	46.7 T cells/million cells Standard Deviation 101.1

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 271 and at Day 451

The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PE specific CD4+ T-cells expressing selected combination of cytokines such as (IL-2, IL-13, IL-17), IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=47 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=41 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 1	63.1 T cells/million cells Standard Deviation 211.4	92.9 T cells/million cells Standard Deviation 266.0
Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 91	797 T cells/million cells Standard Deviation 1082.9	76.2 T cells/million cells Standard Deviation 195.0
Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 271	384.8 T cells/million cells Standard Deviation 539.9	61.4 T cells/million cells Standard Deviation 207.2
Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 451	335.7 T cells/million cells Standard Deviation 493.7	81.2 T cells/million cells Standard Deviation 258.9

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 271 and at Day 451

The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PilA specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=47 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=41 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 1	26.2 T cells/million cells Standard Deviation 45.4	53.3 T cells/million cells Standard Deviation 95.9
Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 91	305.8 T cells/million cells Standard Deviation 321.7	44.6 T cells/million cells Standard Deviation 114.8
Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 271	137.3 T cells/million cells Standard Deviation 163.2	42.1 T cells/million cells Standard Deviation 78.2
Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 451	141 T cells/million cells Standard Deviation 147.1	42.4 T cells/million cells Standard Deviation 95.3

SECONDARY outcome

Timeframe: At Day 1, Day 91, Day 271 and at Day 451

The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of UspA2 specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.

Outcome measures

Outcome measures
Measure	GSK3277511A Group n=47 Participants Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61	Control Group n=41 Participants Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.
Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 1	66.1 T cells/million cells Standard Deviation 177.1	47.2 T cells/million cells Standard Deviation 85.8
Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 91	646.3 T cells/million cells Standard Deviation 545.2	70.3 T cells/million cells Standard Deviation 94.6
Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 271	330.5 T cells/million cells Standard Deviation 278.5	60.8 T cells/million cells Standard Deviation 80.0
Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data Day 451	331.3 T cells/million cells Standard Deviation 310.4	61.5 T cells/million cells Standard Deviation 89.2

Adverse Events

GSK3277511A Group

Serious events: 89 serious events

Other events: 276 other events

Deaths: 1 deaths

Control Group

Serious events: 99 serious events

Other events: 247 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER