Respiratory DisordersPhase 2NCT02075541
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.
A Phase 2 study testing NTHi-10-AS01E in people with Respiratory Disorders, run by GlaxoSmithKline at 14 sites in 2 countries.
Trial summary
The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with moderate and severe persistent airflow obstruction. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Respiratory Disorders
- What is being tested?
- NTHi-10-AS01E
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 8 Jul 2014to 19 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% and ≥ 30% predicted.
- Current or former smoker with a cigarette smoking history of ≥ 10 pack-years.
- Stable COPD patient with documented history of at least 1 moderate or severe acute exacerbation of COPD within the 12 months before Screening.
Show all 13Show fewer
- Regular sputum producer.
- Capable to comply with the daily electronic Diary Card completion throughout the study period, according to investigator's judgement at Visit 1.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception 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.
Who cannot join
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/ product.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
- Previous vaccination with any vaccine containing NTHi antigens.
- Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Chronic administration of non-steroid immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
Show all 29Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of immune-mediated disease other than COPD.
- Administration of systemic corticosteroids within the 30 days before Screening.
- Administration of systemic antibiotics within the 30 days before Screening.
- Chronic use of antibiotics for prevention of acute exacerbations of COPD (AECOPD).
- Receiving oxygen therapy.
- Planned lung transplantation.
- Planned/ underwent lung resection surgery.
- Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.
- Diagnosed with a respiratory disorder other than COPD, or chest X-ray/ CT scan revealing evidence of clinically significant abnormalities not believed to be due to the presence of COPD. Subjects with allergic rhinitis can be enrolled.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines and/ or the bronchodilator used for spirometry assessment during the study.
- Contraindication for spirometry testing.
- Clinically significant abnormality in haematology or biochemistry parameter.
- Acute cardiac insufficiency.
- Malignancies within the previous 5 years or lymphoproliferative disorder.
- Any known disease or condition likely to cause death during the study period.
- Acute disease and/ or fever at the time of Screening.
- Fever is defined as oral or axillary temperature ≥ 37.5°C. The preferred route for recording temperature in this study will be oral.
- Subjects with acute disease and/ or fever at the time of Screening may be enrolled at a later date if enrolment is still open. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Pregnant or lactating female.
- Current alcoholism and/or drug abuse.
- Other condition which the investigator judges may put the safety of the subject at risk through study participation or which may interfere with the study findings.
- Planned move to a location that will complicate participation in the trial through study end.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United Kingdom11 sites
GSK Investigational Site
Bradford, BD9 6RJ
GSK Investigational Site
Dundee, DD1 9SY
GSK Investigational Site
Edinburgh, EH16 4SA
GSK Investigational Site
Leicester, Leicestershire, LE3 9QP
GSK Investigational Site
Liverpool, L9 7AL
GSK Investigational Site
Llanelli, Carmarthenshire, SA14 8QF
GSK Investigational Site
Poole, Dorset, BH15 2JB
GSK Investigational Site
Salford, M6 8HD
GSK Investigational Site
Southampton, SO16 6YD
GSK Investigational Site
Stoke-on-Trent, Staffordshire, ST4 6QG
GSK Investigational Site
Wolverhampton, WV10 0QP
Sweden3 sites
GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Örebro, SE-703 62
About this study
Official title: An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients
The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with moderate and severe persistent airflow obstruction.
- Conditions
- Respiratory Disorders
- Being tested
- NTHi-10-AS01E, NaCl Placebo
- Keywords
- Immunogenicity, Observer-blind, Reactogenicity, Chronic Obstructive Pulmonary Disease, Safety
- Medical subject headings
- Respiration Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTHi-10-AS01EBiological
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NaCl PlaceboDrug
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
| Study group | Role | What they receive |
|---|---|---|
| 10-AS01E group | Experimental | Subjects in this group will receive the investigational NTHi vaccine. Receives: Biological: NTHi-10-AS01E |
| Control group | Placebo comparator | Subjects in this group will receive placebo. Receives: Drug: NaCl Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Any Solicited Local Adverse Events (AEs).
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (from Day 0 to Day 6) after first dose.
Number of Subjects With Any Solicited Local AEs.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (from Day 60 to Day 66) after second dose.
Number of Subjects With Any Solicited General AEs.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.
Number of Subjects With Any Solicited General AEs
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.
Number of Subjects With Any Unsolicited AEs.
Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.
Number of Subjects With Any Unsolicited AEs
Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 0.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 7.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 30.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 60.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 67.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 90.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 270.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 450.
Number of Subjects Reporting 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.
Measured: From first vaccination (Day 0) up to study conclusion (Day 450).
Number of Subjects With Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
Measured: From first vaccination (Day 0) up to study conclusion (Day 450).
Secondary outcomes (5)
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens.
Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay was 153 EL.U/mL for anti-PD.
Measured: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens.
Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 8 EL.U/mL for anti-PE.
Measured: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens.
Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 7 EL.U/mL for anti-PilA.
Measured: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.
Frequency of specific CD4+ T-cells were measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers [such as Interleukin-2 (IL-2), IL-13, IL-17, Interferon-γ (IFN-γ), Tumor Necrosis Factor-α (TNF-α) and Cluster of Differentiation 40 Ligand (CD40L)].The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.
Measured: At Day 0, Day 90, Day 270 and at Day 450.
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.
Frequency of specific CD8+ T-cells were measured by flow cytometry ICS expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L).The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.
Measured: At Day 0, Day 90, Day 270 and at Day 450.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start8 Jul 2014
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075541
- Sponsor's protocol ID
- 200157
- Other IDs
- 2013-003062-13
- Status last verified
- Jun 2018
- First submitted
- 27 Feb 2014
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Baffetta F, Buonsanti C, Moraschini L, Aprea S, Cane M, Lombardi S, Contorni M, Rondini S, Arora AK, Bardelli M, Finco O, Serruto D, Paccani SR. Lung mucosal immunity to NTHi vaccine antigens: Antibodies in sputum of chronic obstructive pulmonary disease patients. Hum Vaccin Immunother. 2024 Dec 31;20(1):2343544. doi: 10.1080/21645515.2024.2343544. Epub 2024 Apr 24.
PubMed 38655676Wilkinson TMA, Schembri S, Brightling C, Bakerly ND, Lewis K, MacNee W, Rombo L, Hedner J, Allen M, Walker PP, De Ryck I, Tasciotti A, Casula D, Moris P, Testa M, Arora AK. Non-typeable Haemophilus influenzae protein vaccine in adults with COPD: A phase 2 clinical trial. Vaccine. 2019 Sep 24;37(41):6102-6111. doi: 10.1016/j.vaccine.2019.07.100. Epub 2019 Aug 22.
PubMed 31447126
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT02075541
- Acronym / sponsor ID
- 200157
- Conditions
- Respiratory Disorders
- Keywords
- Immunogenicity, Observer-blind, Reactogenicity, Chronic Obstructive Pulmonary Disease, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2014 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with moderate and severe persistent airflow obstruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-AS01E group | Experimental | Biological: NTHi-10-AS01ESubjects in this group will receive the investigational NTHi vaccine. |
| Control group | Placebo comparator | Drug: NaCl PlaceboSubjects in this group will receive placebo. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% and ≥ 30% predicted.
- Current or former smoker with a cigarette smoking history of ≥ 10 pack-years.
Key exclusion criteria (29 listed)
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/ product.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
- Previous vaccination with any vaccine containing NTHi antigens.
- Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTHi-10-AS01EIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. | Biological | 10-AS01E group |
| NaCl PlaceboIntramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. | Drug | Control group |
Primary outcome
Number of Subjects With Any Solicited Local Adverse Events (AEs).
Time frame: During a 7-day follow-up period (from Day 0 to Day 6) after first dose.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local AEs.
Time frame: During a 7-day follow-up period (from Day 60 to Day 66) after second dose.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited General AEs.
Time frame: During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited General AEs
Time frame: During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Unsolicited AEs.
Time frame: During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.
Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Number of Subjects With Any Unsolicited AEs
Time frame: During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.
Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 0.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 7.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 30.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 60.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 67.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 90.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 270.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.
Time frame: At Day 450.
Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs).
Time frame: From first vaccination (Day 0) up to study conclusion (Day 450).
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.
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: From first vaccination (Day 0) up to study conclusion (Day 450).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
5 secondary outcomes
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens.
Time frame: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens.
Time frame: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens.
Time frame: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.
Time frame: At Day 0, Day 90, Day 270 and at Day 450.
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.
Time frame: At Day 0, Day 90, Day 270 and at Day 450.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38655676Baffetta F, Buonsanti C, Moraschini L, Aprea S, Cane M, Lombardi S, Contorni M, Rondini S, Arora AK, Bardelli M, Finco O, Serruto D, Paccani SR. Lung mucosal immunity to NTHi vaccine antigens: Antibodies in sputum of chronic obstructive pulmonary disease patients. Hum Vaccin Immunother. 2024 Dec 31;20(1):2343544. doi: 10.1080/21645515.2024.2343544. Epub 2024 Apr 24.
- Derived from this study: PubMed 31447126Wilkinson TMA, Schembri S, Brightling C, Bakerly ND, Lewis K, MacNee W, Rombo L, Hedner J, Allen M, Walker PP, De Ryck I, Tasciotti A, Casula D, Moris P, Testa M, Arora AK. Non-typeable Haemophilus influenzae protein vaccine in adults with COPD: A phase 2 clinical trial. Vaccine. 2019 Sep 24;37(41):6102-6111. doi: 10.1016/j.vaccine.2019.07.100. Epub 2019 Aug 22.
Related trials for Respiratory Disorders
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
RecruitingPhase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTHi-10-AS01E in people with Respiratory Disorders, run by GlaxoSmithKline at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Any Solicited Local Adverse Events (AEs). (time frame: During a 7-day follow-up period (from Day 0 to Day 6) after first dose.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.