Tuberculosis
Conditions
Keywords
Tuberculosis
Brief summary
This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.
Detailed description
The study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1 month apart and follow-up until 1 month post dose 2), which will be performed in an observer blinded manner. This will be followed by 3 years of follow-up which will continue in an open manner. No new subjects will be recruited at the follow-up phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
Intramuscular injection, 2 doses at 0, 1 month
BIOLOGICALComparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system
Intramuscular injection, 2 doses at 0, 1 month
BIOLOGICALComparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline
Intramuscular injection, 2 doses at 0, 1 month
Intramuscular injection, 2 doses at 0, 1 month
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol * A male or female between, and including, 18 and 50 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to any study procedure. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Subjects must have PPD negative skin reactivity (0 mm induration 48 to 72 hours after PPD skin test administration). * Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis. * Seronegative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies * If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. * No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
Exclusion criteria
* History of previous exposure to experimental products containing components of the experimental vaccine. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. * Any chronic drug therapy to be continued during the study period. Vitamins and/or dietary supplements, herbal medications, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (nonsteroidal anti-inflammatory drugs e.g. aspirin, ibuprofen), and acetaminophen are allowed. * History of documented exposure to Mycobacterium tuberculosis. * History of prior vaccination with experimental Mycobacterium tuberculosis vaccines. * Administration of any immunoglobulins, any immunotherapy and/or any blood products within the 3 months preceding the first dose of study vaccination, or planned administrations during the study period. * Participation in another experimental protocol during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency. * History of hypersensitivity to vaccines or vaccine components * History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine. * Volunteers with a personal history of autoimmune disease or who describe a first-degree relative with clearly documented autoimmune disease. * History of any neurological disorders or seizures. * History of chronic alcohol consumption and/or drug abuse. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects. * Pregnant female, lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Immunoglobulin E | At Day 0 | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses | Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) follow-up period after each vaccine dose | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the Active Vaccination Phase (from Day 0 up to Month 2) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With SAEs | From Month 2 up to Month 12 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | At Day 0 | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. |
| Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | At Day 7 | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. |
| Levels of C-reactive Protein | At Day 0 | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 | At Year 2 (Month 24) and Year 3 (Month 36) | Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EU/mL). The reference seropositivity cut-off value for anti-M72 antibodies was ≥ 2.8 EU/mL. |
| Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). Note: No vaccine induced responses were observed for CD8+ T-cells, so no results are presented throughout the record. |
| Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines | At Year 2 (Month 24) and Year 3 (Month 36) | Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). |
| Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | Expressed cytokine combinations for CD4+ T-cells were CD40-L and interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. |
| Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers. |
| Concentrations of IFN-γ Produced in Serum Samples | Prior to (Day 0 and Day 30) and one day (Day 1 and Day 31) after each vaccination | Concentrations are presented as geometric mean concentrations (GMCs), expressed in picogram per milliliter (pg/mL). The reference seropositivity cut-off value was equal to or above (≥) 1 pg/mL. |
| Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The reference seropositivity cut-off values for anti-M72 and anti-Mtb72F antibodies were ≥ 2.8 EU/mL and ≥ 1.0 EU/mL, respectively. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| M72/AS01B Group Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | 40 |
| M72/AS02A Group Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | 40 |
| Mtb72F/AS02A Group Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | 10 |
| Non-adjuvanted Group Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | 10 |
| Control Group Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | 10 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Unspecified reasons | 12 | 9 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | M72/AS01B Group | M72/AS02A Group | Mtb72F/AS02A Group | Non-adjuvanted Group | Control Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 25.0 Years STANDARD_DEVIATION 6.5 | 26.4 Years STANDARD_DEVIATION 7.97 | 28.5 Years STANDARD_DEVIATION 6.95 | 24.8 Years STANDARD_DEVIATION 5.33 | 25.9 Years STANDARD_DEVIATION 7.95 | 25.89 Years STANDARD_DEVIATION 7.11 |
| Race/Ethnicity, Customized Unspecified | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 38 Participants | 39 Participants | 10 Participants | 10 Participants | 10 Participants | 107 Participants |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 9 Participants | 4 Participants | 7 Participants | 67 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 1 Participants | 6 Participants | 3 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 40 / 40 | 40 / 40 | 10 / 10 | 9 / 10 | 10 / 10 |
| serious Total, serious adverse events | 2 / 40 | 0 / 40 | 1 / 10 | 0 / 10 | 1 / 10 |
Outcome results
Primary
Levels of C-reactive Protein
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of C-reactive Protein | 0.10 mg/dL |
| M72/AS02A Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Mtb72F/AS02A Group | Levels of C-reactive Protein | 0.15 mg/dL |
| Non-adjuvanted Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Control Group | Levels of C-reactive Protein | 0.30 mg/dL |
Primary
Levels of C-reactive Protein
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Time frame: At Day 37
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of C-reactive Protein | 0.30 mg/dL |
| M72/AS02A Group | Levels of C-reactive Protein | 0.20 mg/dL |
| Mtb72F/AS02A Group | Levels of C-reactive Protein | 0.20 mg/dL |
| Non-adjuvanted Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Control Group | Levels of C-reactive Protein | 0.25 mg/dL |
Primary
Levels of C-reactive Protein
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Time frame: At Day 31
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of C-reactive Protein | 1.65 mg/dL |
| M72/AS02A Group | Levels of C-reactive Protein | 1.25 mg/dL |
| Mtb72F/AS02A Group | Levels of C-reactive Protein | 1.15 mg/dL |
| Non-adjuvanted Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Control Group | Levels of C-reactive Protein | 0.75 mg/dL |
Primary
Levels of C-reactive Protein
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Time frame: At Day 30
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of C-reactive Protein | 0.10 mg/dL |
| M72/AS02A Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Mtb72F/AS02A Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Non-adjuvanted Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Control Group | Levels of C-reactive Protein | 0.20 mg/dL |
Primary
Levels of C-reactive Protein
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of C-reactive Protein | 0.20 mg/dL |
| M72/AS02A Group | Levels of C-reactive Protein | 0.20 mg/dL |
| Mtb72F/AS02A Group | Levels of C-reactive Protein | 0.20 mg/dL |
| Non-adjuvanted Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Control Group | Levels of C-reactive Protein | 0.15 mg/dL |
Primary
Levels of C-reactive Protein
The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL).
Time frame: At Day 1
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of C-reactive Protein | 1.45 mg/dL |
| M72/AS02A Group | Levels of C-reactive Protein | 1.05 mg/dL |
| Mtb72F/AS02A Group | Levels of C-reactive Protein | 0.70 mg/dL |
| Non-adjuvanted Group | Levels of C-reactive Protein | 0.10 mg/dL |
| Control Group | Levels of C-reactive Protein | 1.10 mg/dL |
Primary
Levels of Immunoglobulin E
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of Immunoglobulin E | 30.10 1000 U/L |
| M72/AS02A Group | Levels of Immunoglobulin E | 61.55 1000 U/L |
| Mtb72F/AS02A Group | Levels of Immunoglobulin E | 46.75 1000 U/L |
| Non-adjuvanted Group | Levels of Immunoglobulin E | 39.55 1000 U/L |
| Control Group | Levels of Immunoglobulin E | 45.25 1000 U/L |
Primary
Levels of Immunoglobulin E
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Time frame: At Day 37
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of Immunoglobulin E | 35.00 1000 U/L |
| M72/AS02A Group | Levels of Immunoglobulin E | 60.35 1000 U/L |
| Mtb72F/AS02A Group | Levels of Immunoglobulin E | 49.15 1000 U/L |
| Non-adjuvanted Group | Levels of Immunoglobulin E | 40.85 1000 U/L |
| Control Group | Levels of Immunoglobulin E | 44.20 1000 U/L |
Primary
Levels of Immunoglobulin E
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Time frame: At Day 31
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of Immunoglobulin E | 34.20 1000 U/L |
| M72/AS02A Group | Levels of Immunoglobulin E | 64.10 1000 U/L |
| Mtb72F/AS02A Group | Levels of Immunoglobulin E | 46.40 1000 U/L |
| Non-adjuvanted Group | Levels of Immunoglobulin E | 39.05 1000 U/L |
| Control Group | Levels of Immunoglobulin E | 45.35 1000 U/L |
Primary
Levels of Immunoglobulin E
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Time frame: At Day 30
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of Immunoglobulin E | 31.05 1000 U/L |
| M72/AS02A Group | Levels of Immunoglobulin E | 58.60 1000 U/L |
| Mtb72F/AS02A Group | Levels of Immunoglobulin E | 43.70 1000 U/L |
| Non-adjuvanted Group | Levels of Immunoglobulin E | 38.10 1000 U/L |
| Control Group | Levels of Immunoglobulin E | 43.55 1000 U/L |
Primary
Levels of Immunoglobulin E
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of Immunoglobulin E | 36.10 1000 U/L |
| M72/AS02A Group | Levels of Immunoglobulin E | 65.50 1000 U/L |
| Mtb72F/AS02A Group | Levels of Immunoglobulin E | 43.25 1000 U/L |
| Non-adjuvanted Group | Levels of Immunoglobulin E | 38.00 1000 U/L |
| Control Group | Levels of Immunoglobulin E | 45.80 1000 U/L |
Primary
Levels of Immunoglobulin E
The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L).
Time frame: At Day 1
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| M72/AS01B Group | Levels of Immunoglobulin E | 29.55 1000 U/L |
| M72/AS02A Group | Levels of Immunoglobulin E | 61.90 1000 U/L |
| Mtb72F/AS02A Group | Levels of Immunoglobulin E | 46.50 1000 U/L |
| Non-adjuvanted Group | Levels of Immunoglobulin E | 41.05 1000 U/L |
| Control Group | Levels of Immunoglobulin E | 41.75 1000 U/L |
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 7 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 39 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 4 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 6 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 7 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 3 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 12 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 13 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 40 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 4 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 38 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 6 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 9 Participants |
| M72/AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 40 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 5 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 8 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 3 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 37 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 4 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 9 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 3 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 40 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 6 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 4 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 5 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 10 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 10 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 10 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 3 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 8 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 24 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 32 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 17 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 24 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 33 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 2 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 18 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 20 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 3 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 3 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 9 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 23 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 1 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 32 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 25 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 6 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 26 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 19 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 25 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 27 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 36 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 15 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 33 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 8 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 36 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 5 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 32 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 33 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 11 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 22 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 7 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 27 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 8 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 23 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 12 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 19 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 9 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 24 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 19 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 21 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 29 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 7 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 24 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 10 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 28 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 5 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 3 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 7 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 7 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 3 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 3 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 6 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 6 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 8 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 7 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 6 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 5 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 7 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 3 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 3 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 3 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 4 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 6 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 6 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 4 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) follow-up period after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 37 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 31 Participants |
| M72/AS01B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 12 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 7 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 33 Participants |
| M72/AS02A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 21 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 8 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 7 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 7 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 4 Participants |
Primary
Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 37 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Inside | 37 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Above | 11 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 29 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 36 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 4 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Above | 7 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 33 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 8 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 7 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Above | 3 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 7 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Above | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 8 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 8 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Above | 2 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 8 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Above | 1 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | WBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
Primary
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 3 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 37 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 3 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 37 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 3 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 36 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 10 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 29 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 37 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 3 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 8 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 36 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 32 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 8 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 6 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 4 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 8 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 6 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 8 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 4 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
Primary
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Time frame: At Day 60
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 11 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 29 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 36 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 36 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 4 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 5 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 37 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 35 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 8 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 2 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 7 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 8 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 3 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 8 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
Primary
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Time frame: At Day 37
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 3 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 37 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 37 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 8 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 30 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 37 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 3 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 4 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 35 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 7 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 3 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 7 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 3 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
Primary
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range.
Time frame: At Day 30
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 39 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 7 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 2 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 33 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 38 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 40 Participants |
| M72/AS01B Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 36 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 40 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 3 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 39 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 38 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 2 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 11 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 37 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 29 Participants |
| M72/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 39 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 1 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 7 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 3 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 8 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 9 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 8 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Inside | 6 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Above | 4 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Eosinophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Monocytes, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Inside | 9 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | ALT, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Creatinine, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haematocrite, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | RBC, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Neutrophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Missing | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | AST, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Lymphocytes, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Below | 1 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Platelets, Inside | 10 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Basophils, Below | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Haemoglobin, Above | 0 Participants |
| Control Group | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | WBC, Above | 0 Participants |
Primary
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 3 continued only for the M72/AS01B Group and M72/AS02A Group.
Time frame: From Month 24 up to Month 36
Population: The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 3 Safety Follow-Up (M72/AS01B and M72/AS02A groups).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M72/AS01B Group | Number of Subjects With SAEs | 0 Participants |
| M72/AS02A Group | Number of Subjects With SAEs | 0 Participants |
Primary
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 2 continued only for the M72/AS01B Group and M72/AS02A Group.
Time frame: From Month 12 up to Month 24
Population: The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 2 Safety Follow-Up (M72/AS01B and M72/AS02A groups).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M72/AS01B Group | Number of Subjects With SAEs | 0 Participants |
| M72/AS02A Group | Number of Subjects With SAEs | 0 Participants |
Primary
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 2 up to Month 12
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M72/AS01B Group | Number of Subjects With SAEs | 2 Participants |
| M72/AS02A Group | Number of Subjects With SAEs | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With SAEs | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With SAEs | 0 Participants |
| Control Group | Number of Subjects With SAEs | 1 Participants |
Primary
Number of Subjects With 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.
Time frame: During the Active Vaccination Phase (from Day 0 up to Month 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M72/AS01B Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| M72/AS02A Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Non-adjuvanted Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Antibody Concentrations Against M. Tuberculosis Fusion Protein M72
Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EU/mL). The reference seropositivity cut-off value for anti-M72 antibodies was ≥ 2.8 EU/mL.
Time frame: At Year 2 (Month 24) and Year 3 (Month 36)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| M72/AS01B Group | Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 | Anti-M72, Month 24 | 38.9 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 | Anti-M72, Month 36 | 29.2 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 | Anti-M72, Month 24 | 21.6 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 | Anti-M72, Month 36 | 19.3 EU/mL |
Secondary
Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F
Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The reference seropositivity cut-off values for anti-M72 and anti-Mtb72F antibodies were ≥ 2.8 EU/mL and ≥ 1.0 EU/mL, respectively.
Time frame: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)
Population: The analysis was performed on the According to protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Day 0 | 1.4 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 1 | 24.7 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 2 | 722.6 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 12 | 59.5 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Day 0 | 0.5 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 1 | 27.6 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 12 | 731.6 EU/mL |
| M72/AS01B Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 2 | 44.7 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 2 | 470.8 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 1 | 11.5 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Day 0 | 1.4 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 12 | 42.5 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 1 | 10.4 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 2 | 30.1 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Day 0 | 0.5 EU/mL |
| M72/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 12 | 473.1 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 12 | 512.1 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 2 | 31.6 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 12 | 43.2 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 1 | 16.0 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 2 | 491.9 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 1 | 14.4 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Day 0 | 1.4 EU/mL |
| Mtb72F/AS02A Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Day 0 | 0.5 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 1 | 1.8 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 2 | 5.3 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 12 | 2.7 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Day 0 | 0.5 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 1 | 0.8 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 2 | 1.4 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Day 0 | 1.4 EU/mL |
| Non-adjuvanted Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 12 | 3.2 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 12 | 1.4 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 2 | 0.5 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 2 | 1.4 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 12 | 0.5 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Day 0 | 1.4 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Month 1 | 0.5 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-M72, Month 1 | 1.4 EU/mL |
| Control Group | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Anti-Mtb72F, Day 0 | 0.5 EU/mL |
Secondary
Concentrations of IFN-γ Produced in Serum Samples
Concentrations are presented as geometric mean concentrations (GMCs), expressed in picogram per milliliter (pg/mL). The reference seropositivity cut-off value was equal to or above (≥) 1 pg/mL.
Time frame: Prior to (Day 0 and Day 30) and one day (Day 1 and Day 31) after each vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| M72/AS01B Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 0 | 0.6 pg/mL |
| M72/AS01B Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 1 | 4.5 pg/mL |
| M72/AS01B Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 30 | 0.6 pg/mL |
| M72/AS01B Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 31 | 77.2 pg/mL |
| M72/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 0 | 0.6 pg/mL |
| M72/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 31 | 20.1 pg/mL |
| M72/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 1 | 1.0 pg/mL |
| M72/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 30 | 0.6 pg/mL |
| Mtb72F/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 31 | 23.4 pg/mL |
| Mtb72F/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 1 | 2.2 pg/mL |
| Mtb72F/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 30 | 0.6 pg/mL |
| Mtb72F/AS02A Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 0 | 0.6 pg/mL |
| Non-adjuvanted Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 0 | 1.0 pg/mL |
| Non-adjuvanted Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 1 | 0.7 pg/mL |
| Non-adjuvanted Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 31 | 1.4 pg/mL |
| Non-adjuvanted Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 30 | 1.1 pg/mL |
| Control Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 31 | 4.1 pg/mL |
| Control Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 30 | 1.1 pg/mL |
| Control Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 1 | 3.3 pg/mL |
| Control Group | Concentrations of IFN-γ Produced in Serum Samples | IFN-γ, Day 0 | 1.0 pg/mL |
Secondary
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
Time frame: At Year 2 (Month 24) and Year 3 (Month 36)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 24 | 1467.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 36 | 1106.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 24 | 574.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 36 | 833.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 24 | 1320.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 36 | 1087.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 24 | 387.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 36 | 373.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 36 | 106.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 24 | 800.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 24 | 787.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 36 | 493.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 24 | 200.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 24 | 307.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 36 | 479.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 36 | 293.0 CD4+ T-cells/million cells |
Secondary
Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule
Expressed cytokine combinations for CD4+ T-cells were CD40-L and interleukin-2 \[IL-2\] or interferon-gamma \[IFN-γ\] or tumour necrosis factor-alpha \[TNF-α\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
Time frame: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Day 0 | 65.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 1 | 883.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 2 | 2333.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 12 | 1234.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Day 0 | 63.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 1 | 466.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 2 | 1394.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 12 | 545.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Day 0 | 41.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 1 | 886.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 2 | 2325.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 12 | 1212.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Day 0 | 34.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 1 | 168.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 2 | 820.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 12 | 317.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 1 | 112.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 1 | 451.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Day 0 | 44.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 2 | 275.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 12 | 321.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Day 0 | 33.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 12 | 718.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 1 | 420.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Day 0 | 50.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Day 0 | 34.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 1 | 250.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 2 | 1466.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 12 | 109.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 12 | 650.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 2 | 1489.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 2 | 744.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 1 | 107.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 12 | 597.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Day 0 | 45.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 1 | 291.5 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 2 | 863.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 12 | 314.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 2 | 335.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Day 0 | 41.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 1 | 732.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 2 | 1729.5 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 12 | 569.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Day 0 | 35.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Day 0 | 90.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 12 | 120.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 1 | 715.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 2 | 1997.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 1 | 141.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 12 | 27.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 2 | 223.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 1 | 33.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 12 | 98.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 1 | 59.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Day 0 | 46.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 12 | 137.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Day 0 | 81.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 2 | 238.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 12 | 50.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Day 0 | 34.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Day 0 | 50.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 2 | 58.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 2 | 110.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 1 | 158.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Day 0 | 57.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 1 | 62.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 2 | 1.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Day 0 | 40.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 1 | 56.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 12 | 1.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 2 | 29.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 12 | 41.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 1 | 82.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Day 0 | 54.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Day 0 | 37.0 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IL-2, Month 12 | 77.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ TNF-α, Month 2 | 15.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ IFN-γ, Month 1 | 62.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 12 | 77.5 CD4+ T-cells/million cells |
| Control Group | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | CD4+ CD40-L, Month 2 | 29.0 CD4+ T-cells/million cells |
Secondary
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). Note: No vaccine induced responses were observed for CD8+ T-cells, so no results are presented throughout the record.
Time frame: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| M72/AS01B Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Day 0 | 90.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 1 | 955.5 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 2 | 2641.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 12 | 1282.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Day 0 | 65.5 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 12 | 769.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 1 | 484.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 2 | 1589.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 12 | 642.0 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 1 | 745.5 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 2 | 2082.5 CD4+ T-cells/million cells |
| Mtb72F/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Day 0 | 58.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Day 0 | 134.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 1 | 173.0 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 12 | 153.5 CD4+ T-cells/million cells |
| Non-adjuvanted Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 2 | 278.0 CD4+ T-cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 12 | 82.0 CD4+ T-cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 2 | 43.0 CD4+ T-cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 1 | 95.5 CD4+ T-cells/million cells |
| Control Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Day 0 | 45.0 CD4+ T-cells/million cells |
Secondary
Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines
Among cytokines expressed were interleukin-2 \[IL-2\] and/or interferon-gamma \[IFN-γ\] and/or tumour necrosis factor-alpha \[TNF-α\] and/or cluster of differentiation 40-ligand \[CD40-L\]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).
Time frame: At Year 2 (Month 24) and Year 3 (Month 36)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| M72/AS01B Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 24 | 1506.0 CD4+ T-cells/million cells |
| M72/AS01B Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 36 | 1313.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 24 | 826.0 CD4+ T-cells/million cells |
| M72/AS02A Group | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines | CD4+ All doubles, Month 36 | 507.0 CD4+ T-cells/million cells |
Secondary
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.
Time frame: At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Day 0 | 3 Participants |
| M72/AS01B Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 1 | 38 Participants |
| M72/AS01B Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 2 | 39 Participants |
| M72/AS01B Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 12 | 39 Participants |
| M72/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Day 0 | 2 Participants |
| M72/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 12 | 35 Participants |
| M72/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 1 | 33 Participants |
| M72/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 2 | 39 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 12 | 8 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 1 | 9 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 2 | 10 Participants |
| Mtb72F/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Day 0 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Day 0 | 0 Participants |
| Non-adjuvanted Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 1 | 3 Participants |
| Non-adjuvanted Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 12 | 2 Participants |
| Non-adjuvanted Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 2 | 5 Participants |
| Control Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 12 | 1 Participants |
| Control Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 2 | 0 Participants |
| Control Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 1 | 0 Participants |
| Control Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Day 0 | 1 Participants |
Secondary
Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers
The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers.
Time frame: At Year 2 (Month 24) and Year 3 (Month 36)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M72/AS01B Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 24 | 31 Participants |
| M72/AS01B Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 36 | 24 Participants |
| M72/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 24 | 36 Participants |
| M72/AS02A Group | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | Month 36 | 23 Participants |