Respiratory Disorders
Conditions
Keywords
Immunogenicity, Observer-blind, Reactogenicity, Chronic Obstructive Pulmonary Disease, Safety
Brief 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.
Interventions
BIOLOGICALNTHi-10-AS01E
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
DRUGNaCl Placebo
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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: * 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.
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Serious Adverse Events (SAEs). | 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. |
| Number of Subjects With Any Solicited General AEs | 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. | 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 | 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. | 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 Reporting Any Potential Immune-mediated Diseases (pIMDs). | 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 Solicited Local Adverse Events (AEs). | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450 | 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. |
| Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450. | 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. |
| Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | At Day 0, Day 90, Day 270 and at Day 450. | 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. |
| Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | At Day 0, Day 90, Day 270 and at Day 450. | 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. |
| Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450. | 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. |
Countries
Sweden, United Kingdom
Participant flow
Recruitment details
145 subjects, aged 40 to 80 years were recruited from 4 sites in Sweden and 11 sites in the United Kingdom.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| 10-AS01E Group Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine. | 73 |
| Control Group Approximately 70 subjects who received 2 doses of placebo. | 72 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other- unable to perform study procedure | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Serious Adverse Event | 1 | 4 |
| Overall Study | Sponsor study termination | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | 10-AS01E Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 67 Years STANDARD_DEVIATION 8.41 | 66.8 Years STANDARD_DEVIATION 7.21 | 66.9 Years STANDARD_DEVIATION 7.81 |
| Race/Ethnicity, Customized White- Caucasian/ European Heritage | 73 Participants | 72 Participants | 145 Participants |
| Sex: Female, Male Female | 34 Participants | 36 Participants | 70 Participants |
| Sex: Female, Male Male | 39 Participants | 36 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 73 | 2 / 72 |
| other Total, other adverse events | 65 / 73 | 42 / 72 |
| serious Total, serious adverse events | 15 / 73 | 17 / 72 |
Outcome results
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.
Time frame: From first vaccination (Day 0) up to study conclusion (Day 450).
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10-AS01E Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs). | 2 Participants |
| Control Group | Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs). | 0 Participants |
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.
Time frame: From first vaccination (Day 0) up to study conclusion (Day 450).
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 15 Participants |
| Control Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 17 Participants |
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.
Time frame: During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs | Any Fatigue | 28 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs | Any Gastrointestinal symptoms | 15 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs | Any Headache | 20 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs | Any Temperature/(Oral) (°C) | 10 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs | Any Temperature/(Oral) (°C) | 1 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs | Any Fatigue | 13 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs | Any Headache | 13 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs | Any Gastrointestinal symptoms | 6 Participants |
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.
Time frame: During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs. | Any Fatigue | 21 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs. | Any Gastrointestinal symptoms | 12 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs. | Any Headache | 19 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited General AEs. | Any Temperature/(Oral) (°C) | 2 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs. | Any Temperature/(Oral) (°C) | 6 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs. | Any Fatigue | 19 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs. | Any Headache | 13 Participants |
| Control Group | Number of Subjects With Any Solicited General AEs. | Any Gastrointestinal symptoms | 10 Participants |
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.
Time frame: During a 7-day follow-up period (from Day 0 to Day 6) after first dose.
Population: Analysis was performed on the Total Vaccinated Cohort (TVC) that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Solicited Local Adverse Events (AEs). | Any Pain | 49 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited Local Adverse Events (AEs). | Any Redness (mm) | 9 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited Local Adverse Events (AEs). | Any Swelling (mm) | 4 Participants |
| Control Group | Number of Subjects With Any Solicited Local Adverse Events (AEs). | Any Pain | 5 Participants |
| Control Group | Number of Subjects With Any Solicited Local Adverse Events (AEs). | Any Redness (mm) | 0 Participants |
| Control Group | Number of Subjects With Any Solicited Local Adverse Events (AEs). | Any Swelling (mm) | 0 Participants |
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.
Time frame: During a 7-day follow-up period (from Day 60 to Day 66) after second dose.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Solicited Local AEs. | Any Pain | 49 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited Local AEs. | Any Redness (mm) | 15 Participants |
| 10-AS01E Group | Number of Subjects With Any Solicited Local AEs. | Any Swelling (mm) | 8 Participants |
| Control Group | Number of Subjects With Any Solicited Local AEs. | Any Pain | 5 Participants |
| Control Group | Number of Subjects With Any Solicited Local AEs. | Any Redness (mm) | 2 Participants |
| Control Group | Number of Subjects With Any Solicited Local AEs. | Any Swelling (mm) | 0 Participants |
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.
Time frame: During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Unsolicited AEs | 25 Participants |
| Control Group | Number of Subjects With Any Unsolicited AEs | 22 Participants |
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.
Time frame: During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 10-AS01E Group | Number of Subjects With Any Unsolicited AEs. | 27 Participants |
| Control Group | Number of Subjects With Any Unsolicited AEs. | 26 Participants |
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.
Time frame: At Day 60.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 8 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 12 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 13 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 11 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 12 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 7 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
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.
Time frame: At Day 0.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 2 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 12 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 15 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 12 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 2 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 4 Participants |
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.
Time frame: At Day 7.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 2 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 8 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 15 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 12 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 10 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 12 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 7 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
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.
Time frame: At Day 30.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 9 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 14 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 14 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 8 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 8 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 12 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 10 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 11 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
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.
Time frame: At Day 67.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 16 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 11 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 8 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 12 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 11 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 11 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 4 Participants |
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.
Time frame: At Day 90.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 13 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 11 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 2 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 8 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 10 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 13 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 10 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 4 Participants |
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.
Time frame: At Day 270.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 4 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 9 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 11 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 13 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 5 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 9 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 11 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 10 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 2 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
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.
Time frame: At Day 450.
Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 17 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 14 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 8 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 10 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 3 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 6 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 7 Participants |
| 10-AS01E Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine above | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | WBC above | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Basophils above | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Eosinophils above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes below | 9 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Lymphocytes above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Monocytes above | 5 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils below | 1 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Neutrophils above | 4 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets below | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Platelets above | 13 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin below | 10 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Haemoglobin above | 6 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | ALT above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST below | 0 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | AST above | 3 Participants |
| Control Group | Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. | Creatinine below | 0 Participants |
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.
Time frame: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10-AS01E Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 0 | 12.3 El.U/mL |
| 10-AS01E Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 30 | 234.3 El.U/mL |
| 10-AS01E Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 60 | 207.5 El.U/mL |
| 10-AS01E Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 90 | 1353.7 El.U/mL |
| 10-AS01E Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 270 | 333.5 El.U/mL |
| 10-AS01E Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 450 | 206.8 El.U/mL |
| Control Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 270 | 16.8 El.U/mL |
| Control Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 0 | 14.5 El.U/mL |
| Control Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 90 | 16.5 El.U/mL |
| Control Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 30 | 15.6 El.U/mL |
| Control Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 450 | 16.2 El.U/mL |
| Control Group | Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PilA antibody, Day 60 | 15.1 El.U/mL |
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.
Time frame: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10-AS01E Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 90 | 1692.1 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 0 | 107.3 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 270 | 598.3 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 60 | 538 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 450 | 463 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 30 | 840.1 EL.U/mL |
| Control Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 450 | 108.4 EL.U/mL |
| Control Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 30 | 102.6 EL.U/mL |
| Control Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 60 | 104.1 EL.U/mL |
| Control Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 90 | 103 EL.U/mL |
| Control Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 270 | 109.3 EL.U/mL |
| Control Group | Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. | Anti-PD antibody, Day 0 | 100.3 EL.U/mL |
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.
Time frame: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10-AS01E Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 0 | 14.1 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 30 | 1007 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 60 | 823.7 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 90 | 10953.4 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 270 | 1743.3 EL.U/mL |
| 10-AS01E Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 450 | 1247.5 EL.U/mL |
| Control Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 270 | 12.6 EL.U/mL |
| Control Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 0 | 14.8 EL.U/mL |
| Control Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 90 | 15 EL.U/mL |
| Control Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 30 | 13.6 EL.U/mL |
| Control Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 450 | 13.6 EL.U/mL |
| Control Group | Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. | Anti-PE antobody, Day 60 | 13.9 EL.U/mL |
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.
Time frame: At Day 0, Day 90, Day 270 and at Day 450.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 0 | 97.1 CD8+ T-cells/ million cells | Standard Deviation 186.24 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 90 | 39.6 CD8+ T-cells/ million cells | Standard Deviation 73.78 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 270 | 55.3 CD8+ T-cells/ million cells | Standard Deviation 59.18 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 450 | 51.5 CD8+ T-cells/ million cells | Standard Deviation 60.19 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 0 | 97.7 CD8+ T-cells/ million cells | Standard Deviation 204.06 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 90 | 44.9 CD8+ T-cells/ million cells | Standard Deviation 47.72 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 270 | 29.9 CD8+ T-cells/ million cells | Standard Deviation 57.16 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 450 | 41 CD8+ T-cells/ million cells | Standard Deviation 74.41 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 0 | 63.1 CD8+ T-cells/ million cells | Standard Deviation 122.12 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 90 | 39.7 CD8+ T-cells/ million cells | Standard Deviation 73.42 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 270 | 27.4 CD8+ T-cells/ million cells | Standard Deviation 34.15 |
| 10-AS01E Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 450 | 63.7 CD8+ T-cells/ million cells | Standard Deviation 98.87 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 270 | 13 CD8+ T-cells/ million cells | Standard Deviation 15.12 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 0 | 47.9 CD8+ T-cells/ million cells | Standard Deviation 72.9 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 270 | 60.3 CD8+ T-cells/ million cells | Standard Deviation 83.47 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 90 | 45.8 CD8+ T-cells/ million cells | Standard Deviation 77.53 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 90 | 80.3 CD8+ T-cells/ million cells | Standard Deviation 125.84 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 270 | 48.7 CD8+ T-cells/ million cells | Standard Deviation 56.33 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 450 | 31.6 CD8+ T-cells/ million cells | Standard Deviation 43.34 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PD, Day 450 | 16.2 CD8+ T-cells/ million cells | Standard Deviation 24.04 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 450 | 31 CD8+ T-cells/ million cells | Standard Deviation 36.17 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 0 | 73.9 CD8+ T-cells/ million cells | Standard Deviation 131.71 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PilA, Day 0 | 23.1 CD8+ T-cells/ million cells | Standard Deviation 45.92 |
| Control Group | Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD8+ T-cells, PE, Day 90 | 30.6 CD8+ T-cells/ million cells | Standard Deviation 59.01 |
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.
Time frame: At Day 0, Day 90, Day 270 and at Day 450.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 0 | 33.1 CD4+ T-cells/ million cells | Standard Deviation 49.97 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 90 | 521.6 CD4+ T-cells/ million cells | Standard Deviation 287.39 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 270 | 189.6 CD4+ T-cells/ million cells | Standard Deviation 146.87 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 450 | 148.6 CD4+ T-cells/ million cells | Standard Deviation 141.11 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 0 | 51.3 CD4+ T-cells/ million cells | Standard Deviation 68.72 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 90 | 857.9 CD4+ T-cells/ million cells | Standard Deviation 642.76 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 270 | 304.4 CD4+ T-cells/ million cells | Standard Deviation 292.46 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 450 | 337.2 CD4+ T-cells/ million cells | Standard Deviation 302.42 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 0 | 29.7 CD4+ T-cells/ million cells | Standard Deviation 53.21 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 90 | 474.4 CD4+ T-cells/ million cells | Standard Deviation 321.58 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 270 | 145 CD4+ T-cells/ million cells | Standard Deviation 164.58 |
| 10-AS01E Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 450 | 157.7 CD4+ T-cells/ million cells | Standard Deviation 117.76 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 270 | 80.3 CD4+ T-cells/ million cells | Standard Deviation 95.6 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 0 | 79.7 CD4+ T-cells/ million cells | Standard Deviation 91.48 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 270 | 71.6 CD4+ T-cells/ million cells | Standard Deviation 90.51 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 90 | 38.4 CD4+ T-cells/ million cells | Standard Deviation 51.61 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 90 | 37.4 CD4+ T-cells/ million cells | Standard Deviation 46.53 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 270 | 51.8 CD4+ T-cells/ million cells | Standard Deviation 59.4 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 450 | 117.8 CD4+ T-cells/ million cells | Standard Deviation 53.24 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PD, Day 450 | 97.8 CD4+ T-cells/ million cells | Standard Deviation 98.4 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 450 | 102.8 CD4+ T-cells/ million cells | Standard Deviation 116.48 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 0 | 69.1 CD4+ T-cells/ million cells | Standard Deviation 82.87 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PilA, Day 0 | 98.3 CD4+ T-cells/ million cells | Standard Deviation 74.27 |
| Control Group | Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. | CD4+ T-cells, PE, Day 90 | 65 CD4+ T-cells/ million cells | Standard Deviation 92.86 |