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.
CompletedPhase 2Results postedLast updated 11 January 2021
What this trial tests
Phase 2 trial testing NTHi Mcat investigational vaccine (GSK3277511A) in Respiratory Disorders in 606 participants. Completed in 26 March 2020.
Adults 40 to 80, any sex, with Respiratory Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 YearPrimary· From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
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
Group
Value
95% CI
GSK3277511A Group
1.22
1.09 – 1.36
Control Group
1.17
1.06 – 1.3
Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 YearPrimary· From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
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
Group
Value
95% CI
GSK3277511A Group
1.22
1.05 – 1.41
Control Group
1.17
1.02 – 1.34
Number of Subjects Reported With Each Solicited Local Adverse Event (AE)Secondary· 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 local symptoms were pain, redness and swelling
Pain, Dose 1
Group
Value
95% CI
GSK3277511A Group
153
Control Group
16
Pain, Dose 2
Group
Value
95% CI
GSK3277511A Group
163
Control Group
13
Redness (mm), Dose 1
Group
Value
95% CI
GSK3277511A Group
18
Control Group
1
Redness (mm), Dose 2
Group
Value
95% CI
GSK3277511A Group
37
Control Group
0
Swelling (mm), Dose 1
Group
Value
95% CI
GSK3277511A Group
13
Control Group
2
Swelling (mm), Dose 2
Group
Value
95% CI
GSK3277511A Group
31
Control Group
0
Number of Subjects Reported With Each Solicited General AESecondary· 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.
Chills, Dose 1
Group
Value
95% CI
GSK3277511A Group
29
Control Group
35
Chills, Dose 2
Group
Value
95% CI
GSK3277511A Group
35
Control Group
28
Fatigue, Dose 1
Group
Value
95% CI
GSK3277511A Group
157
Control Group
167
Fatigue, Dose 2
Group
Value
95% CI
GSK3277511A Group
136
Control Group
130
Fever, Dose 1
Group
Value
95% CI
GSK3277511A Group
24
Control Group
25
Fever, Dose 2
Group
Value
95% CI
GSK3277511A Group
18
Control Group
11
Gastrointestinal symptoms, Dose 1
Group
Value
95% CI
GSK3277511A Group
47
Control Group
54
Gastrointestinal symptoms, Dose 2
Group
Value
95% CI
GSK3277511A Group
39
Control Group
35
Number of Subjects Reported With Any Unsolicited Adverse Event (AE)Secondary· 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.
Group
Value
95% CI
GSK3277511A Group
110
Control Group
103
Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs)Secondary· From first vaccination (Day 1) up to Study end (at Day 451)
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.
Group
Value
95% CI
GSK3277511A Group
6
Control Group
3
Number of Subjects Reported With Any Serious Adverse Event (SAE)Secondary· From first vaccination (Day 1) up to Study end (at Day 451)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
Group
Value
95% CI
GSK3277511A Group
89
Control Group
99
Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months PeriodSecondary· 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
FROM 0 TO 3 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.35
1.1 – 1.66
Control Group
1.15
0.92 – 1.43
FROM 3 TO 6 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.33
1.08 – 1.63
Control Group
1.44
1.19 – 1.75
FROM 6 TO 9 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.36
1.11 – 1.67
Control Group
1.19
0.96 – 1.48
FROM 9 TO 12 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.87
0.69 – 1.11
Control Group
0.9
0.71 – 1.14
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months PeriodSecondary· 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.
FROM 0 TO 3 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.47
1.21 – 1.79
Control Group
1.33
1.09 – 1.63
FROM 3 TO 6 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.56
1.29 – 1.89
Control Group
1.56
1.29 – 1.88
FROM 6 TO 9 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.49
1.23 – 1.82
Control Group
1.29
1.05 – 1.59
FROM 9 TO 12 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.98
0.78 – 1.22
Control Group
1.04
0.84 – 1.3
From 0 TO 12 MONTHS
Group
Value
95% CI
GSK3277511A Group
1.36
1.19 – 1.57
Control Group
1.31
1.15 – 1.48
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months PeriodSecondary· 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 hospitalizat
MILD, FROM 0 TO 3 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.02
± 0.15
Control Group
0.03
± 0.20
MILD, FROM 3 TO 6 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.05
± 0.24
Control Group
0.02
± 0.14
MILD, FROM 6 TO 9 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.03
± 0.19
Control Group
0.03
± 0.18
MILD, FROM 9 TO 12 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.03
± 0.17
Control Group
0.03
± 0.16
MODERATE, FROM 0 TO 3 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.29
± 0.62
Control Group
0.23
± 0.48
MODERATE, FROM 3 TO 6 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.27
± 0.51
Control Group
0.3
± 0.57
MODERATE, FROM 6 TO 9 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.3
± 0.56
Control Group
0.25
± 0.51
MODERATE, FROM 9 TO 12 MONTHS
Group
Value
95% CI
GSK3277511A Group
0.2
± 0.44
Control Group
0.17
± 0.42
Number of Subjects With First Moderate or Severe AECOPDSecondary· 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.
Group
Value
95% CI
GSK3277511A Group
158
Control Group
176
Number of Subjects With First AECOPD of Any SeveritySecondary· 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.
Group
Value
95% CI
GSK3277511A Group
168
Control Group
188
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited AEs reported during the 7-day follow-up period and Unsolicited AEs reported during the 30-day follow-up period after any vaccination. SAEs reported from first vaccination (Day 1) up to Study end (at Day 451 - an average of 15 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GSK3277511A Group
Serious: 89/304 (29%)
Deaths: 1/304
Control Group
Serious: 99/302 (33%)
Deaths: 10/302
Serious adverse events (146 terms)
Reaction
System
GSK3277511A Group
Control Group
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
—
—
Pneumonia
Infections and infestations
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
—
—
Influenza
Infections and infestations
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Transient ischaemic attack
Nervous system disorders
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Cardiac failure
Cardiac disorders
—
—
Cardiac failure congestive
Cardiac disorders
—
—
Bronchitis
Infections and infestations
—
—
Pneumonia pneumococcal
Infections and infestations
—
—
Urosepsis
Infections and infestations
—
—
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Alcohol withdrawal syndrome
Psychiatric disorders
—
—
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Acute left ventricular failure
Cardiac disorders
—
—
Angina pectoris
Cardiac disorders
—
—
Angina unstable
Cardiac disorders
—
—
Arrhythmia
Cardiac disorders
—
—
Other adverse events (159 terms — click to expand)
The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response.
In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care.
The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza \[NTHi\] and Moraxella catarrhalis \[Mcat\]) will be evaluated at pre-defined timepoints (scheduled study visits).
In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 11 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03281876.