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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003062-13 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10-AS01E group | Experimental | Subjects in this group will receive the investigational NTHi vaccine. |
|
| Control group | Placebo Comparator | Subjects in this group will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTHi-10-AS01E | Biological | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450. |
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Inclusion Criteria:
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.
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:
Exclusion Criteria:
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.
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Eskilstuna | SE-631 88 | Sweden | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38655676 | Derived | 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. | |
| 31447126 |
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All enrolled subjects were included in the study.
145 subjects, aged 40 to 80 years were recruited from 4 sites in Sweden and 11 sites in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10-AS01E Group | Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine. |
| FG001 | Control Group | Approximately 70 subjects who received 2 doses of placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2016 | Apr 16, 2018 |
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| NaCl Placebo | Drug | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From first vaccination (Day 0) up to study conclusion (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. | 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. | 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. | 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. | At Day 0, Day 90, Day 270 and at Day 450. |
| Gothenburg |
| SE-413 45 |
| Sweden |
| GSK Investigational Site | Örebro | SE-703 62 | Sweden |
| GSK Investigational Site | Llanelli | Carmarthenshire | SA14 8QF | United Kingdom |
| GSK Investigational Site | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| GSK Investigational Site | Stoke-on-Trent | Staffordshire | ST4 6QG | United Kingdom |
| GSK Investigational Site | Bradford | BD9 6RJ | United Kingdom |
| GSK Investigational Site | Dundee | DD1 9SY | United Kingdom |
| GSK Investigational Site | Edinburgh | EH16 4SA | United Kingdom |
| GSK Investigational Site | Liverpool | L9 7AL | United Kingdom |
| GSK Investigational Site | Poole, Dorset | BH15 2JB | United Kingdom |
| GSK Investigational Site | Salford | M6 8HD | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
| GSK Investigational Site | Wolverhampton | WV10 0QP | United Kingdom |
| Wilkinson 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10-AS01E Group | Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine. |
| BG001 | Control Group | Approximately 70 subjects who received 2 doses of placebo. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was performed on the Total Vaccinated Cohort (TVC) that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | During a 7-day follow-up period (from Day 0 to Day 6) after first dose. |
|
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | During a 7-day follow-up period (from Day 60 to Day 66) after second dose. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | During a 7-day follow-up period (from Day 0 to Day 6) following the first dose. |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | During a 7-day follow-up period (from Day 60 to Day 66) following the second dose. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | During the 30-day follow-up period (from Day 0 to Day 29) following the first dose. |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | During the 30-day follow-up period (from Day 60 to Day 89) following the second dose. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 0. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 7. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 30. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 60. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 67. |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 90. |
|
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 270. |
|
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | At Day 450. |
|
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination (Day 0) up to study conclusion (Day 450). |
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| Primary | 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. | Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented. | Posted | Count of Participants | Participants | From first vaccination (Day 0) up to study conclusion (Day 450). |
|
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| Secondary | 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. | Analysis was performed on the According to Protocol (ATP) cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450. |
|
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| Secondary | 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. | Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450 |
|
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| Secondary | 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. | Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay. | Posted | Geometric Mean | 95% Confidence Interval | El.U/mL | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450. |
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| Secondary | 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. | Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable. | Posted | Mean | Standard Deviation | CD4+ T-cells/ million cells | At Day 0, Day 90, Day 270 and at Day 450. |
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| Secondary | 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. | Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable. | Posted | Mean | Standard Deviation | CD8+ T-cells/ million cells | At Day 0, Day 90, Day 270 and at Day 450. |
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Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10-AS01E Group | Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine. | 1 | 73 | 15 | 73 | 65 | 73 |
| EG001 | Control Group | Approximately 70 subjects who received 2 doses of placebo. | 2 | 72 | 17 | 72 | 42 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dressler's syndrome | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | lp542096@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2016 | Apr 16, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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