A Phase 2 interventional study of NTHi Mcat investigational vaccine (GSK3277511A) and Placebo in Respiratory Disorders, sponsored by GlaxoSmithKline. Completed at 67 sites in 8 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
Among 22 studies in Respiration Disorders by GlaxoSmithKline — none open to participants now, 1 under way, 1 of them phase 3. Respiration Disorders · GlaxoSmithKline.
Among the 22 studies in Respiration Disorders by GlaxoSmithKline, this one is the 3rd largest by enrollment of the 19 interventional ones that give a count, is one of 3 that started in 2017, is one of 4 in phase 2, and was the 17th registered.
359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.
Browse Respiration Disorders studies →None of the 22 studies in Respiration Disorders by GlaxoSmithKline is open now. The open studies under Respiration Disorders, anywhere →
Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2017.
This study's enrollment of 606 is above the median of 69 across 216 interventional studies indexed under Respiration Disorders.
Median enrollment 120 across the 19 interventional studies, 2,116 across the 3 observational. Of the 21 that completed or were terminated, 10 (48%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Respiration Disorders by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
The purpose of this Phase IIB proof-of-concept (POC) study in moderate to very severe COPD patients (i.e. GOLD grade 2, 3 and 4) aged 40 to 80 years with a history of moderate or severe acute exacerbations of COPD (AECOPD) in the previous 12 months is to evaluate whether the NTHi-Mcat vaccine can reduce the frequency of AECOPD in this population and to assess the vaccine's safety, reactogenicity and immunogenicity.
Several formulations of a vaccine containing the NTHi antigens (low or high formulation) either non-adjuvanted or combined with different adjuvants (aluminium [Al], adjuvant system) were already evaluated in two previous Phase I clinical trials (NTHI-002 in healthy adults aged 18 - 40 years and NTHI-003 in current and former healthy smokers of 50-70 years old). The investigational vaccines were well-tolerated, with an acceptable safety and reactogenicity profile. These studies allowed the dose selection of the NTHi antigens (low formulation) and the adjuvant system currently evaluated for the first time in moderate and severe COPD patients aged 45 - 81 years in the Phase II study NTHI-004.
The safety, reactogenicity and immunogenicity of different formulations of the NTHi-Mcat investigational vaccine have been evaluated in the Phase I study in healthy adults aged 19 - 40 years and in current and former smokers aged 50 - 70 years (study NTHI MCAT-001). Based on results obtained up to 30 days post-Dose 2 from this study, the adjuvanted formulation containing NTHi proteins PD and PE-PilA and of UspA2 has been selected for evaluation in the current NTHI MCAT-002 study. Placebo will be used as a control. The NTHi-Mcat investigational vaccine and placebo will be given on top of standard of care to subjects in the respective study groups.
In the current study, moderate, severe and very severe COPD patients (i.e. GOLD grade 2, 3 and 4) with a history of AECOPD will receive 2 doses of the NTHi-Mcat investigational vaccine or placebo intramuscularly (IM) according to a 0, 2 month vaccination schedule, in addition to standard care.
Scheduled study visits, during which the effect of immunisation against NTHi and Mcat will be evaluated, will take place at pre-defined timepoints.
In addition to the scheduled study visits, ad hoc AECOPD-driven study visit(s) and/ or phone contact(s) will take place for each AECOPD occurring from first vaccination up to study conclusion:
Rationale for the protocol amendment:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable COPD patient* with documented history** of at least 1 moderate or severe AECOPD within the 12 months before Screening.
Patient for whom the last episode of AECOPD is resolved for at least 30 days at the time of first vaccination.
has practiced adequate for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
Subjects who received systemic corticosteroids within this period may be enrolled at a later date if enrolment is still open.
Inhaled and topical steroids are allowed.
Subjects who received systemic antibiotics within this period may be enrolled at a later date if enrolment is still open.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Myocardial infarction or unstable angina in the last 6 months. Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months Class IV Heart failure
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) at Day 1 and Day 61.
Biological: NTHi Mcat investigational vaccine (GSK3277511A)
Healthy males and females, 40 to 80 years of age, who received two doses of placebo vaccine at Day 1 and Day 61.
Biological: Placebo
Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Subjects Reported With Each Solicited Local Adverse Event (AE)
Assessed solicited local symptoms were pain, redness and swelling
Time frame: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61
Number of Subjects Reported With Each Solicited General AE
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.
Time frame: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61
Number of Subjects Reported With Any Unsolicited Adverse Event (AE)
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.
Time frame: During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered approximately at Day 1 and Day 61
Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs)
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.
Time frame: From first vaccination (Day 1) up to Study end (at Day 451)
Number of Subjects Reported With Any Serious Adverse Event (SAE)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
Time frame: From first vaccination (Day 1) up to Study end (at Day 451)
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
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.
Time frame: 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)
Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period
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.
Time frame: 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)
Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period
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.
Time frame: 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)
Number of Subjects With First Moderate or Severe AECOPD
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Subjects With First AECOPD of Any Severity
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Subjects With First AECOPD Classified by Severity
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Days With Moderate and Severe AECOPDs
The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Days With AECOPDs of Any Severity
The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Days With AECOPDs Classified by Severity
The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD
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. Respiratory pathogens NTHi and Mcat was determined by Polymerase chain reaction (PCR) analysis in sputum samples.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity
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
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity
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.
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD
The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity
The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity
The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
Time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA)
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.)
Time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
Anti-PE Antibody Concentrations as Measured by ELISA
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.
Time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
Anti-PilA Antibody Concentrations as Measured by ELISA
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.
Time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
Anti-UspA2 Antibody Concentrations as Measured by ELISA
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.
Time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
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
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.
Time frame: At Day 1, Day 91, Day 271 and at Day 451
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
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.
Time frame: At Day 1, Day 91, Day 271 and at Day 451
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
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.
Time frame: At Day 1, Day 91, Day 271 and at Day 451
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
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.
Time frame: At Day 1, Day 91, Day 271 and at Day 451
| Milestone | GSK3277511A Group | Control Group |
|---|---|---|
| Started | 304 | 302 |
| Completed | 281 | 263 |
| Not completed | 23 | 39 |
| Withdrew: Adverse event | 4 | 15 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Withdrawal by subject | 11 | 15 |
| Withdrew: Migrated / moved from the study area | 2 | 0 |
| Withdrew: Other | 5 | 5 |
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.
| exacerbations per person-year | GSK3277511A Group | Control Group |
|---|---|---|
| Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year | 1.22 (1.09 to 1.36) | 1.17 (1.06 to 1.3) |
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.
| exacerbations per person-year | GSK3277511A Group | Control Group |
|---|---|---|
| Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year | 1.22 (1.05 to 1.41) | 1.17 (1.02 to 1.34) |
Assessed solicited local symptoms were pain, redness and swelling
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Pain, Dose 1 | 153 | 16 |
| Pain, Dose 2 | 163 | 13 |
| Redness (mm), Dose 1 | 18 | 1 |
| Redness (mm), Dose 2 | 37 | 0 |
| Swelling (mm), Dose 1 | 13 | 2 |
| Swelling (mm), Dose 2 | 31 | 0 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Chills, Dose 1 | 29 | 35 |
| Chills, Dose 2 | 35 | 28 |
| Fatigue, Dose 1 | 157 | 167 |
| Fatigue, Dose 2 | 136 | 130 |
| Fever, Dose 1 | 24 | 25 |
| Fever, Dose 2 | 18 | 11 |
| Gastrointestinal symptoms, Dose 1 | 47 | 54 |
| Gastrointestinal symptoms, Dose 2 | 39 | 35 |
| Headache, Dose 1 | 98 | 76 |
| Headache, Dose 2 | 75 | 64 |
| Myalgia, Dose 1 | 78 | 72 |
| Myalgia, Dose 2 | 74 | 43 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects Reported With Any Unsolicited Adverse Event (AE) | 110 | 103 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs) | 6 | 3 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects Reported With Any Serious Adverse Event (SAE) | 89 | 99 |
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.
| exacerbations per person-year | GSK3277511A Group | Control Group |
|---|---|---|
| FROM 0 TO 3 MONTHS | 1.35 (1.1 to 1.66) | 1.15 (0.92 to 1.43) |
| FROM 3 TO 6 MONTHS | 1.33 (1.08 to 1.63) | 1.44 (1.19 to 1.75) |
| FROM 6 TO 9 MONTHS | 1.36 (1.11 to 1.67) | 1.19 (0.96 to 1.48) |
| FROM 9 TO 12 MONTHS | 0.87 (0.69 to 1.11) | 0.9 (0.71 to 1.14) |
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.
| exacerbations per person-year | GSK3277511A Group | Control Group |
|---|---|---|
| FROM 0 TO 3 MONTHS | 1.47 (1.21 to 1.79) | 1.33 (1.09 to 1.63) |
| FROM 3 TO 6 MONTHS | 1.56 (1.29 to 1.89) | 1.56 (1.29 to 1.88) |
| FROM 6 TO 9 MONTHS | 1.49 (1.23 to 1.82) | 1.29 (1.05 to 1.59) |
| FROM 9 TO 12 MONTHS | 0.98 (0.78 to 1.22) | 1.04 (0.84 to 1.3) |
| From 0 TO 12 MONTHS | 1.36 (1.19 to 1.57) | 1.31 (1.15 to 1.48) |
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.
| exacerbations per person | GSK3277511A Group | Control Group |
|---|---|---|
| MILD, FROM 0 TO 3 MONTHS | 0.02 ± 0.15 | 0.03 ± 0.20 |
| MILD, FROM 3 TO 6 MONTHS | 0.05 ± 0.24 | 0.02 ± 0.14 |
| MILD, FROM 6 TO 9 MONTHS | 0.03 ± 0.19 | 0.03 ± 0.18 |
| MILD, FROM 9 TO 12 MONTHS | 0.03 ± 0.17 | 0.03 ± 0.16 |
| MODERATE, FROM 0 TO 3 MONTHS | 0.29 ± 0.62 | 0.23 ± 0.48 |
| MODERATE, FROM 3 TO 6 MONTHS | 0.27 ± 0.51 | 0.3 ± 0.57 |
| MODERATE, FROM 6 TO 9 MONTHS | 0.3 ± 0.56 | 0.25 ± 0.51 |
| MODERATE, FROM 9 TO 12 MONTHS | 0.2 ± 0.44 | 0.17 ± 0.42 |
| SEVERE, FROM 0 TO 3 MONTHS | 0.04 ± 0.24 | 0.05 ± 0.23 |
| SEVERE, FROM 3 TO 6 MONTHS | 0.05 ± 0.22 | 0.06 ± 0.29 |
| SEVERE, FROM 6 TO 9 MONTHS | 0.05 ± 0.29 | 0.05 ± 0.24 |
| SEVERE, FROM 9 TO 12 MONTHS | 0.01 ± 0.11 | 0.05 ± 0.24 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects With First Moderate or Severe AECOPD | 158 | 176 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects With First AECOPD of Any Severity | 168 | 188 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| AFTER 1 MONTH POST DOSE 2, MILD | 27 | 27 |
| AFTER 1 MONTH POST DOSE 2, MODERATE | 144 | 154 |
| AFTER 1 MONTH POST DOSE 2, SEVERE | 30 | 41 |
The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.
| Days | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Days With Moderate and Severe AECOPDs | 16.6 ± 14.29 | 15.6 ± 13.93 |
The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
| Days | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Days With AECOPDs of Any Severity | 15.9 ± 13.79 | 15.3 ± 13.51 |
The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).
| Days | GSK3277511A Group | Control Group |
|---|---|---|
| MILD, AFTER 1 MONTH POST DOSE 2 | 8.9 ± 3.56 | 12.3 ± 9.11 |
| MODERATE, AFTER 1 MONTH POST DOSE 2 | 16.1 ± 13.90 | 14.5 ± 10.50 |
| SEVERE, AFTER 1 MONTH POST DOSE 2 | 20.4 ± 16.78 | 21.2 ± 23.85 |
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. Respiratory pathogens NTHi and Mcat was determined by Polymerase chain reaction (PCR) analysis in sputum samples.
| exacerbations per person-year | GSK3277511A Group | Control Group |
|---|---|---|
| Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD | 0.32 (0.25 to 0.42) | 0.32 (0.24 to 0.42) |
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.
| exacerbations per person- year | GSK3277511A Group | Control Group |
|---|---|---|
| Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity | 0.39 (0.30 to 0.50) | 0.35 (0.27 to 0.45) |
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
| exacerbations per person | GSK3277511A Group | Control Group |
|---|---|---|
| MILD, AFTER 1 MONTH POST DOSE 2 | 0.06 ± 0.28 | 0.03 ± 0.21 |
| MODERATE, AFTER 1 MONTH POST DOSE 2 | 0.3 ± 0.67 | 0.31 ± 0.74 |
| SEVERE, AFTER 1 MONTH POST DOSE 2 | 0.02 ± 0.18 | 0.01 ± 0.11 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD | 62 | 62 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity | 70 | 67 |
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.
| Participants | GSK3277511A Group | Control Group |
|---|---|---|
| AFTER 1 MONTH POST DOSE 2, MILD | 15 | 7 |
| AFTER 1 MONTH POST DOSE 2, MODERATE | 58 | 59 |
| AFTER 1 MONTH POST DOSE 2, SEVERE | 4 | 4 |
The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
| Days | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD | 14 ± 10.43 | 12.3 ± 5.59 |
The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
| Days | GSK3277511A Group | Control Group |
|---|---|---|
| Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity | 13.3 ± 9.76 | 12.1 ± 5.72 |
The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
| Days | GSK3277511A Group | Control Group |
|---|---|---|
| AFTER 1 MONTH POST DOSE 2, MILD | 9.5 ± 3.54 | 9.9 ± 6.83 |
| AFTER 1 MONTH POST DOSE 2, MODERATE | 13.8 ± 10.41 | 12.5 ± 5.62 |
| AFTER 1 MONTH POST DOSE 2, SEVERE | 17.3 ± 11.02 | 7.5 ± 1.00 |
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.)
| EU/mL. | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 103.7 (93.8 to 114.7) | 95.4 (86.3 to 105.4) |
| Day 31 | 1048.1 (910.2 to 1206.8) | 98.2 (85.3 to 113.1) |
| Day 61 | 654.6 (572.3 to 748.9) | 95.5 (83.6 to 109.1) |
| Day 91 | 1521.4 (1357.6 to 1704.9) | 90.3 (80.6 to 101.3) |
| Day 271 | 546 (480.3 to 620.8) | 94.8 (83.6 to 107.4) |
| Day 451 | 444.1 (390.2 to 505.4) | 97.9 (85.9 to 111.5) |
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.
| EU/mL. | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 20.9 (17.6 to 24.8) | 21.6 (18.2 to 25.7) |
| Day 31 | 1108.1 (921.5 to 1332.5) | 20.7 (17.2 to 24.9) |
| Day 61 | 872.8 (726.6 to 1048.3) | 20.5 (17.1 to 24.6) |
| Day 91 | 6020 (5181.2 to 6994.7) | 20.1 (17.3 to 23.4) |
| Day 271 | 1254.9 (1069.5 to 1472.5) | 19.3 (16.5 to 22.5) |
| Day 451 | 835.2 (715.0 to 975.6) | 19.7 (16.8 to 23.0) |
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.
| EU/mL. | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 8.3 (6.9 to 9.8) | 8.5 (7.1 to 10.1) |
| Day 31 | 153 (124.2 to 188.6) | 9.2 (7.5 to 11.4) |
| Day 61 | 134.2 (109.7 to 164.2) | 8.8 (7.2 to 10.8) |
| Day 91 | 913.5 (770.5 to 1082.9) | 8.9 (7.5 to 10.5) |
| Day 271 | 189.6 (159.2 to 225.7) | 8 (6.8 to 9.5) |
| Day 451 | 126.5 (106.1 to 150.8) | 8.3 (6.9 to 9.9) |
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.
| EU/mL | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 540.3 (452.6 to 645.0) | 604.7 (507.2 to 721.0) |
| Day 31 | 1092.1 (997.5 to 1195.5) | 485.2 (442.9 to 531.6) |
| Day 61 | 848.7 (781.5 to 921.5) | 473.5 (436.2 to 513.9) |
| Day 91 | 1223.7 (1110.8 to 1348.0) | 446 (404.5 to 491.8) |
| Day 271 | 645.1 (582.1 to 714.8) | 445.4 (402.7 to 492.6) |
| Day 451 | 575.9 (512.9 to 646.7) | 468.5 (416.5 to 527.1) |
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.
| T cells/million cells | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 56.6 ± 125.7 | 59.7 ± 118.2 |
| Day 91 | 890.2 ± 988.8 | 55.8 ± 88.2 |
| Day 271 | 364.6 ± 363.9 | 51.8 ± 90.9 |
| Day 451 | 267 ± 282.6 | 46.7 ± 101.1 |
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.
| T cells/million cells | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 63.1 ± 211.4 | 92.9 ± 266.0 |
| Day 91 | 797 ± 1082.9 | 76.2 ± 195.0 |
| Day 271 | 384.8 ± 539.9 | 61.4 ± 207.2 |
| Day 451 | 335.7 ± 493.7 | 81.2 ± 258.9 |
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.
| T cells/million cells | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 26.2 ± 45.4 | 53.3 ± 95.9 |
| Day 91 | 305.8 ± 321.7 | 44.6 ± 114.8 |
| Day 271 | 137.3 ± 163.2 | 42.1 ± 78.2 |
| Day 451 | 141 ± 147.1 | 42.4 ± 95.3 |
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.
| T cells/million cells | GSK3277511A Group | Control Group |
|---|---|---|
| Day 1 | 66.1 ± 177.1 | 47.2 ± 85.8 |
| Day 91 | 646.3 ± 545.2 | 70.3 ± 94.6 |
| Day 271 | 330.5 ± 278.5 | 60.8 ± 80.0 |
| Day 451 | 331.3 ± 310.4 | 61.5 ± 89.2 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK3277511A Group | 1/304 (0.3%) | 89/304 (29.3%) | 276/304 (90.8%) |
| Control Group | 10/302 (3.3%) | 99/302 (32.8%) | 247/302 (81.8%) |
| Event | GSK3277511A Group | Control Group |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 41/304 | 53/302 |
| PneumoniaInfections and infestations | 5/304 | 15/302 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 7/304 | 7/302 |
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 1/304 | 4/302 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/304 | 4/302 |
| Atrial fibrillationCardiac disorders | 4/304 | 2/302 |
| InfluenzaInfections and infestations | 4/304 | 2/302 |
| Urinary tract infectionInfections and infestations | 0/304 | 3/302 |
| Transient ischaemic attackNervous system disorders | 3/304 | 0/302 |
| Cardiac failureCardiac disorders | 0/304 | 2/302 |
| Event | GSK3277511A Group | Control Group |
|---|---|---|
| Injection site painGeneral disorders | 213/304 | 30/302 |
| FatigueGeneral disorders | 195/304 | 197/302 |
| HeadacheNervous system disorders | 127/304 | 111/302 |
| MyalgiaMusculoskeletal and connective tissue disorders | 115/304 | 94/302 |
| Gastrointestinal disorderGastrointestinal disorders | 71/304 | 77/302 |
| ChillsGeneral disorders | 52/304 | 52/302 |
| Injection site erythemaGeneral disorders | 43/304 | 1/302 |
| PyrexiaGeneral disorders | 39/304 | 32/302 |
| Injection site swellingGeneral disorders | 35/304 | 3/302 |
| NasopharyngitisInfections and infestations | 13/304 | 13/302 |
| Age, Continuous(Years) | GSK3277511A Group | Control Group | Total |
|---|---|---|---|
| Mean | 65.7 ± 7.5 | 66.3 ± 7.3 | 66.0 ± 7.4 |
| Sex: Female, Male(Participants) | GSK3277511A Group | Control Group | Total |
|---|---|---|---|
| Female | 120 | 125 | 245 |
| Male | 184 | 177 | 361 |
| Race/Ethnicity, Customized(Participants) | GSK3277511A Group | Control Group | Total |
|---|---|---|---|
| American Indian Or Alaska Native | 0 | 1 | 1 |
| Asian - Central / South Asian Heritage | 2 | 0 | 2 |
| Asian - South East Asian Heritage | 0 | 1 | 1 |
| Black Or African American | 5 | 4 | 9 |
| Other | 1 | 0 | 1 |
| White - Arabic / North African Heritage | 2 | 0 | 2 |
| White - Caucasian / European Heritage | 294 | 296 | 590 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Nov 2017 to primary completion in Mar 2020, 27 months.
Results were first posted in Jan 2021, 9 months after primary completion.
Of 12 phase 2 interventional studies under Respiration Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 33. This study's 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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